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ISUOG Consensus Statement on rationalization of early‐pregnancy care and provision of ultrasonography in context of SARS‐CoV‐2

ISUOG Consensus Statement on rationalization of early‐pregnancy care and provision of... CONSENSUS STATEMENT ISUOG Consensus Statement on rationalization of early-pregnancy care and provision of ultrasonography in context of SARS-CoV-2 INTRODUCTION In view of the challenges of the current coronavirus (SARS-CoV-2) pandemic and to protect both patients and healthcare providers (physicians, sonographers, allied healthcare professionals), the International Society of Ultrasound of Obstetrics and Gynecology (ISUOG) has compiled the following evidence and expert-opinion-based guidance for the management of early-pregnancy complications. This statement provides proposals and options for managing patients referred for assessment by early-pregnancy healthcare practitioners during the coronavirus disease 2019 (COVID-19) pandemic. Transvaginal ultrasonography is a crucial part of clinical decision-making in early pregnancy. However, appropriate triage is now essential to allow prioritization of use of this resource by pregnancies at high risk of complications, mainly ectopic pregnancy, in which hospital visits will be safer than remote consultation. Temporarily reducing physical patient throughput will reduce the risk of SARS-CoV-2 transmission between patients and between patients and healthcare professionals. Clinicians carrying out ultrasound scans are in close proximity to patients for a significant period of time and have been shown to be at high risk of being infected by SARS-CoV-2 . Rationalizing patient visits and the provision of pregnancy care is vital to allow mobilization of staff and resources in response to this unprecedented pandemic whilst ensuring that women at risk of early-pregnancy complications continue to be safely cared for. Considering the inevitable reduction in resources and capacity, which limits the number of scan appointments available, we recommend that early-pregnancy appointments should be triaged to one of the following three options:  Scans and/or visits that need to be undertaken without delay;  Scans and/or visits that can be delayed without affecting clinical care;  Scans and/or visits that can be avoided for the duration of the pandemic. This consensus statement focuses on women contacting their local early-pregnancy support services (e.g. early-pregnancy unit, emergency rooms with ultrasound, ultrasound clinic) with common complaints. Our proposed recommendations can be adapted to individual sites based on their resource availability and infrastructure, in order to continue to use ultrasound when indicated whilst reducing its use to the essential minimum. Guidance on rationalization of gynecological ultrasound services in the context of the COVID-19 pandemic have been provided in a separate document . This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1002/uog.22046 This article is protected by copyright. All rights reserved. Accepted Article Recommendations on triage of early-pregnancy scans based on onset of symptoms and on findings during previous ultrasound assessments are outlined in Tables 1 and 2, respectively. Justification for these is provided within this document. Table 1 Recommended rationalization of early-pregnancy management including ultrasound scans (USS), based on symptoms, in context of COVID-19 pandemic Symptom Details Recommended action Scans that need to be undertaken without delay Abdominal or pelvic pain (no Referrals from urgent care Offer scan within 24 h.† previous scan). centers, emergency rooms, primary care. Quantify pain using visual analogue score (1–10). Heavy bleeding for more than Referrals from urgent care Offer scan within 24 h.† 24 h and systemic symptoms of centers, emergency rooms, blood loss. primary care. Bleeding score 3–4. Presence of risk factors for Referrals from urgent care Offer scan within 24 h.† ectopic pregnancy* with pain centers, emergency rooms, and/or bleeding. primary care. Scans that can be delayed without affecting clinical care Moderate bleeding. Referrals from urgent care Telephone consultation with centers, emergency rooms, experienced clinician. primary care. Ask patient to take UPT in 1 week: Bleeding score 2. - Negative result: no follow-up; - Positive result: offer USS. Heavy bleeding that has resolved. Referrals from urgent care Telephone consultation with centers, emergency rooms, experienced clinician. primary care. Ask patient to take UPT in 1 week: Bleeding score 3–4, now resolved. - Negative result: no follow-up; - Positive result: offer USS. Early-pregnancy scans than can be avoided for duration of pandemic Reassurance. Referrals from urgent care Telephone consultation with centers, emergency rooms, experienced clinician. primary care. No routine scan. Previous miscarriage(s). Referral because of previous Telephone consultation with miscarriage(s). experienced clinician. No routine scan. Light bleeding with or without Referrals from urgent care Telephone consultation with pain, not troublesome to patient. centers, emergency rooms, experienced clinician. primary care. No routine scan. Bleeding score 1. Quantify pain using visual analogue score (1–10). *Risk factors: previous ectopic pregnancy; previous fallopian-tube surgery; previous pelvic or abdominal surgery; sexually transmitted infections; pelvic inflammatory disease; use of intrauterine contraceptive device or intrauterine system; use of assisted reproductive technology. UPT, urine pregnancy test. †When carrying out triage over telephone, clinical judgment must always be used, and if there are concerns about the patient’s clinical condition, provision should be made for immediate review. This article is protected by copyright. All rights reserved. Accepted Article Table 2 Recommended rationalization of early-pregnancy follow-up based on initial ultrasound scan (USS) findings, in context of COVID-19 pandemic Scan Finding Details Recommended action Live normally sited pregnancy. Scan shows embryo with No follow-up. heartbeat (even if it does not correspond to menstrual dates). Re-date pregnancy accordingly. Normally sited pregnancy of Scan shows early normally sited Findings consistent with menstrual unknown viability (PUV). pregnancy without embryo with dates: no follow-up. heartbeat. Findings not consistent with menstrual dates: explain risk of miscarriage and consider urine pregnancy test and telephone follow-up in 2 weeks. Pregnancy of unknown location Scan unable to identify Blood test to be taken as per local (PUL). intrauterine or extrauterine protocol. Measure β-hCG with or pregnancy. without progesterone. M6 model can be used (http://earlypregnancycare.co.uk/). Triage according to model or local policy. Ectopic pregnancy. Extrauterine or uterine ectopic Emphasis on conservative pregnancy. management, if possible. Use methotrexate with caution and following MDT discussion. Do not perform surgery unless USS is reviewed by senior clinician, and no other management option is available. If laparoscopy is performed, ensure strict precautions are taken to filter CO and use appropriate PPE. Alternatively, consider mini- laparotomy. Miscarriage. Normally sited pregnancy Perform medical or manual vacuum meeting miscarriage criteria. aspiration if possible. Regional anesthesia should be considered. Molar pregnancy. Ultrasound suggesting features For review by senior clinician of, or complete or partial, molar regarding management. pregnancy. Conditions that will require treating Hyperemesis gravidarum. Nausea and vomiting in Use PUQE screening tool. pregnancy requiring antiemetic Follow protocol regarding management. mediations to be prescribed. Ambulatory care if required. β-hCG, β‐human chorionic gonadotropin; MDT, multidisciplinary team; PPE, personal protective equipment; PUQE, pregnancy unique quantification of emesis. This article is protected by copyright. All rights reserved. Accepted Article GENERAL GUIDANCE Screening for SARS-CoV-2 All women in need of care should be triaged based on their symptoms and infection status. Ideally, this should be carried out over the phone by a senior healthcare practitioner prior to an appointment. However, in the event that the patient is first seen in the clinic, the healthcare professional undertaking triage should wear appropriate personal protective equipment (PPE). Triaging for common symptoms, such as cough and fever , is critical before a patient gains access to a clinical area for an ultrasound scan or consultation. Screening for travel, occupation, contact and cluster (TOCC) risk factors should also be implemented (Appendix 1). If the local prevalence of SARS- CoV-2 increases, a policy of managing all patients as high risk may need to be implemented at some point. We also recommend that senior healthcare practitioners acquire and consider the details of the clinical history of the women to determine whether they need to attend the hospital or clinic. Policy for patients with suspected or confirmed COVID-19 Any woman with suspected or confirmed COVID-19 should be asked to not attend the unit. If assessment is required, they must be seen in a designated COVID-19 area. Only screen-negative patients or patients with suspected COVID-19 who need to be reviewed without delay should be asked to attend the unit. If an ultrasound scan is required, we recommend that one ultrasound machine and room is designated for patients with suspected or confirmed COVID-19, if possible. It is important to clean the equipment according to safety guidelines . Any patient with a suspicion of possible SARS-CoV-2 infection must immediately be highlighted to all healthcare team members. Patients with suspicion of COVID-19 requiring admission If a patient with suspicion of COVID-19 is stable, they should be sent home to self-isolate for 7 days, if clinically appropriate. Ideally, any patient who is cohabiting with someone who shows possible symptoms of COVID-19 should self-isolate for 14 days; however, in the context of early-pregnancy care this is unlikely to be practical. Any rooms or areas in the department in which the patient was present will require deep cleaning. If the patient requires admission to the hospital, the location will depend on the reason for admission and availability of a side room until SARS-CoV-2 testing confirms their status. Any patient with a suspicion of possible SARS-CoV-2 infection must immediately be highlighted to all healthcare team members. APPOINTMENTS AND TRIAGE New appointments during normal working hours Referrals from urgent-care centers, emergency rooms, midwives and primary-care practitioners to early-pregnancy support services should be made via a dedicated phone number, if available, in order to allow telephone-based triage of both early-pregnancy symptoms and risk of COVID-19 by an experienced member of the team. If this is not possible due to logistic limitations or legal requirements, then the clinician on call to cover emergency gynecology should be contacted directly for discussion and advice. A standardized proforma should be completed to screen the patient for This article is protected by copyright. All rights reserved. Accepted Article TOCC risk factors and symptoms. The form includes three patient-specific details (name, date of birth, unique patient identifier); if a unique patient identifier is not available, then recording the patient’s address is advised (Appendix 1). This proforma can also be used to record the discussion accurately and in detail, and will determine if the patient requires urgent review or if advice can be provided remotely. This proforma is a medical record of the consultation and can be kept with the patient’s records. A basic requirement in all cases is that the woman should have a positive urine pregnancy test (UPT) in order for them to be considered for referral to early-pregnancy services. Cases of gynecological emergency, such as suspected ovarian torsion, should be discussed with the senior clinician on call. New appointments out of normal working hours (evenings, nights and weekends) Referrals should be made to the clinician on call covering emergency gynecology (if possible via telephone). This applies to out-of-hours primary-care practitioners as well as healthcare personnel working in the emergency room. Phone triage of patients should be applied as follows:  Acutely unwell patients should be advised to attend the emergency room. If they are already in the emergency room, they should be reviewed there by the responsible clinician on call for gynecology;  If ‘semi-acute’ assessment is required, the patient should be directed to a gynecology assessment unit or emergency room for review;  If the patient is stable, patient details should be collected. If possible, an experienced clinician should contact the patient by telephone for further triage assessment. Triage Ideally, triage should be performed remotely via telephone. Triage should collect the following information (Appendix 1), although this can be adapted based on available resources and infrastructure:  Unique patient identifier;  Symptoms related to COVID-19;  TOCC risk factors;  Details of presenting complaint (and advice given). Presenting complaint/request The most common presenting complaints are vaginal bleeding with or without pelvic pain. Objective measures of vaginal bleeding include a pictorial blood-loss assessment chart (Figure 1) . A visual analog score ranging from 0 to 10 (0 indicating no pain and 10 severe pain) can be used to document the level of pelvic pain. This article is protected by copyright. All rights reserved. Accepted Article Figure 1 Pictorial bleeding chart 0 – no bleeding 1 – minimal bleeding 2 – moderate bleeding 3 – soaked sanitary towel 4 – passing clots or flooding Passing clots or flooding It is important to note that if a woman presenting with vaginal bleeding and/or pelvic pain has had a previous ultrasound scan showing a normally sited pregnancy (ongoing or failed), they should first have a telephone consultation with an experienced clinician as soon as is practical, before being considered for ultrasound assessment. SYMPTOM-BASED ASSESSMENT AND FOLLOW-UP Early-pregnancy scans that need to be undertaken without delay (Appendix 4)  If a pregnant woman has pelvic pain and has not had a pelvic scan before documenting a normally sited pregnancy in the uterus, she should be invited to attend for an ultrasound scan within 24 h.  If a patient in early pregnancy has heavy vaginal bleeding (bleeding score of 3 or higher) for more than 24 h and develops symptoms due to blood loss, they should be invited to attend for an ultrasound scan within 24 h.  If a patient with risk factors for ectopic pregnancy develops symptoms (i.e. pelvic pain and/or vaginal bleeding), they should be invited to attend for an ultrasound scan within 24 h. Risk factors for ectopic pregnancy include : a) Previous ectopic pregnancy; b) Previous fallopian-tube surgery; c) Previous pelvic or abdominal surgery; d) Sexually transmitted infection; e) Pelvic inflammatory disease; f) Presence of an intrauterine contraceptive device or intrauterine system; g) Use of assisted reproductive technology. When carrying out telephone triage, clinical judgment must always be used, and if there are concerns about the patient’s clinical condition, provision should be made for immediate review. Early-pregnancy scans that can be delayed without affecting clinical care (Appendix 4)  If a patient in early pregnancy has moderate vaginal bleeding (bleeding score of 2), she can be asked to wait and repeat a UPT in 1 week: a) If the UPT is negative, no follow-up needs to be arranged; b) If the UPT is positive, an ultrasound assessment should be offered. The timing of this scan will depend on the patient’s clinical symptoms. This article is protected by copyright. All rights reserved. Accepted Article  If a patient in early pregnancy has had heavy vaginal bleeding (bleeding score of 3 or higher) which has now resolved, she can be asked to repeat a UPT in 1 week: a) If the UPT is negative, no follow-up needs to be arranged; b) If the UPT is positive, an ultrasound assessment should be offered. The timing of this scan will depend on the patient’s clinical symptoms. Early-pregnancy scans that can be avoided for the duration of the COVID-19 pandemic (Appendix 4)  Asymptomatic women in early pregnancy who request an ultrasound scan for reassurance, irrespective of risk factors.  Asymptomatic women in early pregnancy with a history of previous miscarriage(s).  Patients in early pregnancy who have minimal symptoms, such as light vaginal bleeding (bleeding score of 1) with or without mild pelvic discomfort (quantified using the visual analog scale for pelvic pain) that resolves spontaneously. Follow-up after ultrasound scan has been carried out (Appendix 5)  Live intrauterine pregnancy or intrauterine pregnancy of unknown viability: the patient should not be offered further ultrasound scans, unless it is deemed necessary clinically. Patients with a pregnancy of unknown viability can be asked to perform a UPT in 2 weeks’ time.  Pregnancy of unknown location (PUL): a blood test should be taken as per local protocol, measuring β-human chorionic gonadotropin (β-hCG) with or without progesterone. The most sensitive validated method of interpreting these results is via a two-step protocol (Figure 2) comprising initial serum progesterone level and the M6 risk prediction model, 7,8 which utilizes initial β-hCG, initial progesterone and 48-h β-hCG levels . In units in which measurement of progesterone is not part of the standard protocol, the version of the model using β-hCG alone can be used. Patients can then be managed in accordance with the model outcome and local policy. The M6 model is available to use for free online (http://earlypregnancycare.co.uk/). The model triages women with a PUL as being at high or low risk of complications as follows: a) Low-risk failing PUL: the patient should be advised to take UPT after 2 weeks; if the test is positive, they should contact the early-pregnancy unit; b) Low-risk intrauterine pregnancy: the patient should undergo a transvaginal scan after 1 week to confirm the location and viability of the pregnancy; c) High risk for ectopic pregnancy: the patient should be advised to return to the clinical unit for a repeat β-hCG measurement and ultrasound assessment after 48 h. This article is protected by copyright. All rights reserved. Accepted Article Figure 2 Proposed clinical management using the M6 model for characterization of pregnancies of unknown location (PUL) Step 1 Step 2  Nausea and vomiting in pregnancy (hyperemesis gravidarum): the patient should be assessed over the phone and advised regarding antiemetics. A validated screening tool for pregnant patients with nausea and vomiting is provided in Appendix 2 and a list of recommended antiemetic medications is provided in Appendix 3, as derived from UK guidance (and may be amended according to country or practice), for discussion over the phone . Prescriptions can be sent to primary-care practitioners or directly to the patient, if possible. If intravenous hydration is required, ambulatory departments would be an ideal location . The rare possibility of a molar pregnancy should be considered in patients with hyperemesis gravidarum and other symptoms, such as vaginal bleeding. In the event of routine dating ultrasound assessments being delayed as the clinical burden of the pandemic heightens, women should be offered assessment in early-pregnancy support services if gestational trophoblastic disease is suspected.  Ectopic pregnancy: patients should be managed in accordance with local protocols, with an emphasis on conservative management, if possible. Accurate diagnosis of an ectopic pregnancy is critical for guiding management; thus, ultrasound scans should be reviewed by the most senior clinician available. In the event that a senior clinician is at home self- isolating or not in the hospital, consideration should be given to allow review of ultrasound images online, with appropriate security. Suggestions and important good practice points relating to management of patients with an ectopic pregnancy include: This article is protected by copyright. All rights reserved. Accepted Article a) Expectant management: ensure appropriate follow-up, reduce contact with the patient as much as possible, limit the number of ultrasound scans and perform β- hCG monitoring if possible. b) Medical management: the commonly used medication is the antimetabolite methotrexate . Body surface area is used to calculate dosing. There is a known low risk of immunosuppression with use of methotrexate . It is currently unknown whether immunosuppression increases the effect of SARS-CoV-2 infection and whether administering such medication in SARS-CoV-2-positive patients exacerbates pneumonia-related complications. It is likely that the detrimental effects of methotrexate in patients with COVID-19 are minimal, but this possibility must be considered and medical treatment should be discussed with a senior clinician and reviewed in a multidisciplinary meeting. Screening of women prior to administration of methotrexate can be considered depending on local hospital policy. c) A joint statement by the UK Royal Colleges of Surgeons has stated that laparoscopy 13,14 should be carried out only in selected situations during the COVID-19 pandemic . Other national bodies, such as the British Society of Gynaecological Endoscopy and the Royal College of Obstetricians and Gynaecologists, permit the use of laparoscopy but with necessary precautions. There is limited evidence on the risk of SARS-CoV-2 infection during laparoscopy; therefore, during laparoscopic surgery, strict precautions should be taken to filter CO escaping into the operating theatre and the theatre staff should wear appropriate PPE . Laparotomy should be considered as an alternative to laparoscopy if these strict precautions cannot be met confidently.  Miscarriage: patients should be managed in accordance with local protocols. Counseling should be offered and performed over the phone, if possible. However, there should be an effort to reduce inpatient admissions; ideal options are medical management and use of manual vacuum aspiration if available in the local unit : a) Women undergoing expectant or medical management do not need to be offered further ultrasound scans, but should be asked to carry out a UPT in 3 weeks. If the diagnosis is made in hospital, patients should be provided with adequate analgesia, such as combined paracetamol and codeine preparations. Units should aim to provide telephone consultation to women 3 weeks following their miscarriage to assess physical and emotional wellbeing, if resources are available. b) The availability of surgery will need to be reviewed locally on a daily basis, and if surgical management is indicated, appropriate precautions related to surgery and PPE must be taken. If appropriate and available, manual vacuum aspiration should be performed to reduce the risk and required resources associated with general anesthesia. SCHEDULING AND ORGANIZING APPOINTMENTS This article is protected by copyright. All rights reserved. Accepted Article Pre-existing appointments  A review of the clinical urgency of all existing appointments should be made by the medical team on a weekly basis;  All non-urgent scans should be postponed for (at least) 14 days and organized according to the recommended schemes of essential care;  For routine or non-urgent appointments, women should be advised by phone that their pregnancy care will not be compromised but will be modified to keep her and her baby safe during the SARS-CoV-2 outbreak. Women should be advised not to attend the hospital, and to self-isolate for 14 days if appropriate, based on local and national guidelines. Precautions that should be taken in the waiting areas and examination rooms 1. Considering the recommendation for social distancing, it is important to respect the time of scheduled visits, to space out the appointment intervals in order to prevent crowding in the waiting room and to space the seats in the waiting areas to at least 2 meters apart. 2. Hand sanitizer should be made available at the entrance to and within the waiting rooms. Pregnant patients and their partners (if present) should be advised to use it immediately upon arrival, at frequent intervals during their stay in the department and prior to the ultrasound scan. If hand sanitizer is not available due to shortage, women should be advised to wash their hands with soap for a minimum of 20 sec prior to the scan. 3. Facemasks must be made available and used according to previously published guidance . Specifically, patients with symptoms or judged to have suspected or probable COVID-19 should wear a surgical mask. Sonographers should wear a surgical facemask or respirator (N95, FFP2, FFP3) depending on the risk profile of the patient. 4. Patients should be asked, when arranging their appointment, to either attend on their own or with only one other adult. No children or adult over the age of 60 years should attend the appointment. Women with symptoms suggestive of possible SARS-CoV-2 infection should avoid visiting the unit, unless there is a strong clinical indication for a visit. In such circumstances, the woman should be seen and assessed in a designated ‘contaminated’ area or SARS-CoV-2 assessment area. Guidance for staff undertaking routine or specialist ultrasound scans 1. Guidance on cleaning and disinfection of ultrasound transducers and equipment, and how to protect the patients and ultrasound providers during obstetric and gynecological scans, has been provided in a separate document . 2. All recommendations from local infection-control departments should be followed, including:  The sonographer’s arms should be bare below the elbows;  The sonographer should not wear a watch or any jewelry. 3. Practitioners should wash their hands or use hand sanitizer both before and after direct patient contact. 4. Practitioners should use latex-free disposable gloves during the ultrasound examination and change after each patient. 5. We recommend the use of a three-ply surgical mask as a minimum when performing ultrasound scans, as sonographers spend a significant time during an examination in close This article is protected by copyright. All rights reserved. Accepted Article proximity to the patient. When managing patients with suspected/probable/confirmed COVID-19, an appropriate respirator should be used (N95, FFP2, FFP3) . 6. The use of single-use gel packs is recommended, instead of gel containers, even for transabdominal scans. 7. Non-clinical staff (e.g. receptionists and clerks) are advised to follow local infection-control procedures. If they are able to perform their tasks without being in close proximity to patients, use of a three-ply surgical mask should not be necessary. 8. All personnel working in ultrasound units should be aware of the potential symptoms of SARS- CoV-2 infection, such as new onset of cough, fever and shortness of breath. If they develop any of these symptoms, they should immediately seek medical advice and arrange testing, if allowed by local protocols. Coordinating your local unit during the COVID-19 pandemic In addition to the usual day-to-day requirements for running your local unit, we recommend the following:  All PPE must be checked daily to ensure your unit is stocked and prepared;  All staff must be fit tested for FFP3 masks and records must be kept;  Managers should anticipate that staff (or members of their family) may become unwell during the pandemic, and therefore, careful planning of staff and contingency planning should be carried out in accordance with local availability;  If patients are tested for SARS-CoV-2, ensure that records of the tests sent are kept and that these results are checked daily. Ensure that the patient is informed of the result, and if they were admitted, the ward staff and team in the hospital are also informed as soon as possible;  If multidisciplinary team meetings (MDT) are relevant to practice, we highly encourage units to conduct weekly MDT, which can be arranged using an online meeting platform (e.g. Zoom), to discuss cases;  Considering that there is a high risk of SARS-CoV-2 transmission between staff, social distancing with colleagues should be observed when possible and meetings should be kept to the minimum necessary. Meal breaks should be taken in isolation and not as a group. This article is protected by copyright. All rights reserved. Accepted Article REFERENCES 1. Abramowicz JS, Basseal JM, Brezinka C, Dall’Asta A, Deng J, Harrison G, Marsal K, Lee JCS, Lim A, Miloro P, Poon LC, Salvesen KJ, Sande R, ter Haar G, Westerway SC, Xie MX, Lees C. 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Accepted Article AUTHORS T. Bourne, Tommy’s National Centre for Miscarriage Research, Queen Charlotte’s and Chelsea Hospital, Imperial College, London, UK; Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium; KU Leuven, Department of Development and Regeneration, Leuven, Belgium C. Kyriacou, Tommy’s National Centre for Miscarriage Research, Queen Charlotte’s and Chelsea Hospital, Imperial College, London, UK A. Coomarasamy, Tommy’s National Centre for Miscarriage Research, Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, UK M. Al-Memar, Tommy’s National Centre for Miscarriage Research, Queen Charlotte’s and Chelsea Hospital, Imperial College, London, UK M. Leonardi, Acute Gynecology, Early Pregnancy & Advanced Endoscopic Surgery Unit, Sydney Medical School Nepean, University of Sydney Nepean Hospital, Penrith, Sydney, Australia E. Kirk, Early Pregnancy and Acute Gynaecology Unit, Royal Free NHS Foundation Trust, London, UK C. Landolfo, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Dipartimento Scienze della Salute della Donna, del Bambino e di Sanità Pubblica, Rome, Italy M. Blanchette-Porter, Larner College of Medicine at University of Vermont Obstetrics, Gynecology, and Reproductive Sciences Division, Reproductive Medicine and Infertility Burlington, Vermont, USA R. Small, Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Bordesley Green East, Birmingham, UK G. Condous, Acute Gynecology, Early Pregnancy & Advanced Endoscopic Surgery Unit, Sydney Medical School Nepean, University of Sydney Nepean Hospital, Penrith, Sydney, Australia D. Timmerman, Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium; KU Leuven, Department of Development and Regeneration, Leuven, Belgium This article is protected by copyright. All rights reserved. Accepted Article Appendix 1 Checklist for symptoms and TOCC Patient name: Patient date of birth: Patient unique patient identifier (UPI): Patient address (if UPI not available): 1 Influenza-like illness symptoms Fever  Droplet Precautions Cough for patient with respiratory symptoms Sore throat Shortness of breath Diarrhea and/or vomiting  Contact Precautions None of above Information cannot be obtained 2 TOCC: 14 days before onset of symptoms History of recent Travel * If influenza-like-illness Date of travel: from to symptoms +ve plus Area: TOCC +ve High risk Occupation (e.g. laboratory workers, healthcare workers, wild animals related work)  Prompt isolation  Airborne, Droplet History of unprotected Contact with: & Contact a Human case confirmed with COVID-19, OR Precautions b Consumption of wild animals in areas known to have COVID-19 Clustering of influenza-like illness / pneumonia (≥ 2 affected persons) None of above Information cannot be obtained 3 Types of Isolation Precautions required: Droplet Precautions Contact Precautions Airborne Precaution Nil Reason for referral/call and advice given: Date: Name & Signature: Designation: Droplet precautions: put a mask on the patient; single room; healthcare worker uses PPE appropriately, including a mask, upon entry to room. Contact precautions: single room; healthcare worker uses PPE appropriately upon entry to room, including gloves and gown; use disposable equipment. Airborne precautions: put a mask on the patient; negative-pressure isolation room; healthcare worker uses PPE appropriately upon entry to room, including wearing a fit-test approved respirator, gloves, gown, face and eye protection; negative-pressure isolation room; restrict susceptible healthcare workers from entering the room; use disposable equipment. This article is protected by copyright. All rights reserved. Accepted Article Appendix 2 Early pregnancy hyperemesis rapid assessment tool Pregnancy Unique Quantification of Emesis (PUQE) scoring system Complete for all patients presenting with nausea and vomiting in early pregnancy 1. In the last 12 hours, for how long have you felt nauseated or sick to your stomach? More than Not at all 1 hour or less 2–3 hours 4–6 hours 6 hours Score=1 Score=2 Score=3 Score=4 Score=5 2. In the last 12 hours have you vomited or thrown up? 7 or more times 5–6 3–4 1–2 I did not throw up Score=5 Score=4 Score=3 Score=2 Score=1 3. How many times have you had retching or dry heaves without bringing anything up? None 1–2 3–4 5–6 7 or more Score=1 Score=2 Score=3 Score=4 Score=5 Score interpretation Mild nausea and vomiting of pregnancy Offer antiemetics as per protocol Score < 6 Advise to return if symptoms worsen Moderate nausea and vomiting of pregnancy Offer antiemetics as per protocol Score 7–12 Advise to return if symptoms worsen Severe nausea and vomiting/hyperemesis gravidarum Requires secondary care level treatment: refer to gynecology team Score ≥ 13 Ambulatory care if available This article is protected by copyright. All rights reserved. Accepted Article 9, 16 Appendix 3 Recommended medication for management of nausea and vomiting in early pregnancy Drug Mode of action Dosing/administration Safety Side effects First Line Cyclizine Antihistamine Oral/IV/IM/PR Well established safety profile in Sedation. Anticholinergic side effects H1 receptor antagonist 50mg 8 hourly, Slow IV injection. pregnancy (tachycardia, dry mouth, dizziness, Anticholinergic properties SC infusion (150mg over 24 No evidence of teratogenicity constipation, blurred vision), hours) euphoric/hallucinogenic effects Xonvea Antihistamine Oral Established as safe Sedation, anticholinergic side effects (doxylamine with pyridoxine H1 receptor antagonist Diclectin: 10mg doxylamine + Previous concerns over increased (B6) ) Anti-emetic action of pyridoxine 10mg. 2-4 Tablets per risk of birth defects disproven pyridoxine unclear day in divided doses Prochlorperazine Phenothiazide Oral: 5-10mg TDS Well established safety profile in Extrapyramidal side effects Dopamine antagonist Sublingual: 3-6mg BD pregnancy IM injection:12.5mg TDS No evidence of teratogenicity Second Line Metoclopramide Combined dopamine and 5- Oral/IV/IM Well established safety profile in Extrapyramidal side effects (acute hydroxytriptamine (5-HT) 10mg three times daily pregnancy dystonias, oculogyric crisis). Should antagonist Subcutaneous infusion 30-100mg No evidence of teratogenicity be prescribed for short periods, in 24 hours maximum 5 days advised by IV doses over at least 3 minutes European Medicines Agency Ondansetron 5-HT type 3 receptor Oral/IV/IM/PR/SL Has been linked with oral facial Constipation, flushing, arrhythmias antagonist which acts both 4-8mg three times daily defects (cleft lip/palate). The Prolonged Q-T syndrome (higher risk centrally and peripherally Subcutaneous infusion up to largest observational studies with associated electrolyte 32mg in 24 hours suggest no evidence of imbalance) teratogenicity or adverse pregnancy effects This article is protected by copyright. All rights reserved. Accepted Article Appendix 4 Flowchart summarizing recommended rationalization of early-pregnancy management including ultrasound scans (USS), based on symptoms, in context of COVID-19 pandemic Positive UPT Bleeding score Risk factors of Bleeding score Asymptomatic Light bleeding Pelvic pain - >3 for > 24 h ectopic Asymptomatic Bleeding score >3 but (history of +/- pain not no previous and pregnancy (for bleeding previous troublesome symptomatic and pain +/- 0 reassurance) scan settled miscarriage) to patient of anemia bleeding Not for scan. Not for scan. Wait, repeat Refer to Refer to Offer USS UPT in antenatal antenatal within 24 h 1 week services services To call if If UPT+, offer symptoms USS persist/recur This article is protected by copyright. All rights reserved. Accepted Article Appendix 5 Flowchart summarizing recommended rationalization of early-pregnancy follow-up based on initial ultrasound scan (USS) findings, in context of COVID-19 pandemic ​A & E PUV - Pregnancy of u nkn own viab ility GP PUL - Pregnancy of unknown location Other referrals EPU - Early Pregnancy Unit PPE - Person al pro tective equipment UPT - Urinary pr egnanc y test MVA - Manu al vacuu m asp ir atio n ​Telephone Triage (dedicated number in the day-time, and oncall doctor at night or weekend) ​Decide on CO VID19 risk Decide on urgency High risk for Apparent low ris k COVID19 or for COVID19 confirmed case​ Telephone a dvice or s ee Telephone a dvice or s ee patient in a dedicated patient in EPU COVID19 area​ Use COV ID19- ​Wa sh ha nds or specific USS use s anitizer See very Consult by machine See within 7 soon (within telephone only Use appropriate days if 24 hours) +/- (no need for Use PPE PPE necessary scan (use clinical scan) judgement) Abdominal or pelvic pa in ​Light PV bleeding +/- Moderate PV mild pain in early pregnancy​ bleeding, or heavy PV bleeding that has Hyperemesis Any symptoms of ectopic settled: pregnancy + risk factor(s) UPT in 1 week; for ectopic pregnancy if +, for TVS Excessive bleeding in early pregnancy Pelvic Ultrasound Follow ISUOG practica l Live pregnancy or No further scans guidance on PUV PUV - UPT in 2 weeks scanning ​Expectant Incomplete: Expectant management or management Miscarriage Methotrexa te or Missed: Medical La paroscopy or management or MVA​ La parotomy Ectopic pregnancy PUL Consider RCS and BSGE/ RCO G guidelines f or PUL - use M6 model la paroscopy www.earlypregna ncycare.co.uk This article is protected by copyright. All rights reserved. Accepted Article http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Ultrasound in Obstetrics & Gynecology Pubmed Central

ISUOG Consensus Statement on rationalization of early‐pregnancy care and provision of ultrasonography in context of SARS‐CoV‐2

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Pubmed Central
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10.1002/uog.22046
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Abstract

CONSENSUS STATEMENT ISUOG Consensus Statement on rationalization of early-pregnancy care and provision of ultrasonography in context of SARS-CoV-2 INTRODUCTION In view of the challenges of the current coronavirus (SARS-CoV-2) pandemic and to protect both patients and healthcare providers (physicians, sonographers, allied healthcare professionals), the International Society of Ultrasound of Obstetrics and Gynecology (ISUOG) has compiled the following evidence and expert-opinion-based guidance for the management of early-pregnancy complications. This statement provides proposals and options for managing patients referred for assessment by early-pregnancy healthcare practitioners during the coronavirus disease 2019 (COVID-19) pandemic. Transvaginal ultrasonography is a crucial part of clinical decision-making in early pregnancy. However, appropriate triage is now essential to allow prioritization of use of this resource by pregnancies at high risk of complications, mainly ectopic pregnancy, in which hospital visits will be safer than remote consultation. Temporarily reducing physical patient throughput will reduce the risk of SARS-CoV-2 transmission between patients and between patients and healthcare professionals. Clinicians carrying out ultrasound scans are in close proximity to patients for a significant period of time and have been shown to be at high risk of being infected by SARS-CoV-2 . Rationalizing patient visits and the provision of pregnancy care is vital to allow mobilization of staff and resources in response to this unprecedented pandemic whilst ensuring that women at risk of early-pregnancy complications continue to be safely cared for. Considering the inevitable reduction in resources and capacity, which limits the number of scan appointments available, we recommend that early-pregnancy appointments should be triaged to one of the following three options:  Scans and/or visits that need to be undertaken without delay;  Scans and/or visits that can be delayed without affecting clinical care;  Scans and/or visits that can be avoided for the duration of the pandemic. This consensus statement focuses on women contacting their local early-pregnancy support services (e.g. early-pregnancy unit, emergency rooms with ultrasound, ultrasound clinic) with common complaints. Our proposed recommendations can be adapted to individual sites based on their resource availability and infrastructure, in order to continue to use ultrasound when indicated whilst reducing its use to the essential minimum. Guidance on rationalization of gynecological ultrasound services in the context of the COVID-19 pandemic have been provided in a separate document . This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1002/uog.22046 This article is protected by copyright. All rights reserved. Accepted Article Recommendations on triage of early-pregnancy scans based on onset of symptoms and on findings during previous ultrasound assessments are outlined in Tables 1 and 2, respectively. Justification for these is provided within this document. Table 1 Recommended rationalization of early-pregnancy management including ultrasound scans (USS), based on symptoms, in context of COVID-19 pandemic Symptom Details Recommended action Scans that need to be undertaken without delay Abdominal or pelvic pain (no Referrals from urgent care Offer scan within 24 h.† previous scan). centers, emergency rooms, primary care. Quantify pain using visual analogue score (1–10). Heavy bleeding for more than Referrals from urgent care Offer scan within 24 h.† 24 h and systemic symptoms of centers, emergency rooms, blood loss. primary care. Bleeding score 3–4. Presence of risk factors for Referrals from urgent care Offer scan within 24 h.† ectopic pregnancy* with pain centers, emergency rooms, and/or bleeding. primary care. Scans that can be delayed without affecting clinical care Moderate bleeding. Referrals from urgent care Telephone consultation with centers, emergency rooms, experienced clinician. primary care. Ask patient to take UPT in 1 week: Bleeding score 2. - Negative result: no follow-up; - Positive result: offer USS. Heavy bleeding that has resolved. Referrals from urgent care Telephone consultation with centers, emergency rooms, experienced clinician. primary care. Ask patient to take UPT in 1 week: Bleeding score 3–4, now resolved. - Negative result: no follow-up; - Positive result: offer USS. Early-pregnancy scans than can be avoided for duration of pandemic Reassurance. Referrals from urgent care Telephone consultation with centers, emergency rooms, experienced clinician. primary care. No routine scan. Previous miscarriage(s). Referral because of previous Telephone consultation with miscarriage(s). experienced clinician. No routine scan. Light bleeding with or without Referrals from urgent care Telephone consultation with pain, not troublesome to patient. centers, emergency rooms, experienced clinician. primary care. No routine scan. Bleeding score 1. Quantify pain using visual analogue score (1–10). *Risk factors: previous ectopic pregnancy; previous fallopian-tube surgery; previous pelvic or abdominal surgery; sexually transmitted infections; pelvic inflammatory disease; use of intrauterine contraceptive device or intrauterine system; use of assisted reproductive technology. UPT, urine pregnancy test. †When carrying out triage over telephone, clinical judgment must always be used, and if there are concerns about the patient’s clinical condition, provision should be made for immediate review. This article is protected by copyright. All rights reserved. Accepted Article Table 2 Recommended rationalization of early-pregnancy follow-up based on initial ultrasound scan (USS) findings, in context of COVID-19 pandemic Scan Finding Details Recommended action Live normally sited pregnancy. Scan shows embryo with No follow-up. heartbeat (even if it does not correspond to menstrual dates). Re-date pregnancy accordingly. Normally sited pregnancy of Scan shows early normally sited Findings consistent with menstrual unknown viability (PUV). pregnancy without embryo with dates: no follow-up. heartbeat. Findings not consistent with menstrual dates: explain risk of miscarriage and consider urine pregnancy test and telephone follow-up in 2 weeks. Pregnancy of unknown location Scan unable to identify Blood test to be taken as per local (PUL). intrauterine or extrauterine protocol. Measure β-hCG with or pregnancy. without progesterone. M6 model can be used (http://earlypregnancycare.co.uk/). Triage according to model or local policy. Ectopic pregnancy. Extrauterine or uterine ectopic Emphasis on conservative pregnancy. management, if possible. Use methotrexate with caution and following MDT discussion. Do not perform surgery unless USS is reviewed by senior clinician, and no other management option is available. If laparoscopy is performed, ensure strict precautions are taken to filter CO and use appropriate PPE. Alternatively, consider mini- laparotomy. Miscarriage. Normally sited pregnancy Perform medical or manual vacuum meeting miscarriage criteria. aspiration if possible. Regional anesthesia should be considered. Molar pregnancy. Ultrasound suggesting features For review by senior clinician of, or complete or partial, molar regarding management. pregnancy. Conditions that will require treating Hyperemesis gravidarum. Nausea and vomiting in Use PUQE screening tool. pregnancy requiring antiemetic Follow protocol regarding management. mediations to be prescribed. Ambulatory care if required. β-hCG, β‐human chorionic gonadotropin; MDT, multidisciplinary team; PPE, personal protective equipment; PUQE, pregnancy unique quantification of emesis. This article is protected by copyright. All rights reserved. Accepted Article GENERAL GUIDANCE Screening for SARS-CoV-2 All women in need of care should be triaged based on their symptoms and infection status. Ideally, this should be carried out over the phone by a senior healthcare practitioner prior to an appointment. However, in the event that the patient is first seen in the clinic, the healthcare professional undertaking triage should wear appropriate personal protective equipment (PPE). Triaging for common symptoms, such as cough and fever , is critical before a patient gains access to a clinical area for an ultrasound scan or consultation. Screening for travel, occupation, contact and cluster (TOCC) risk factors should also be implemented (Appendix 1). If the local prevalence of SARS- CoV-2 increases, a policy of managing all patients as high risk may need to be implemented at some point. We also recommend that senior healthcare practitioners acquire and consider the details of the clinical history of the women to determine whether they need to attend the hospital or clinic. Policy for patients with suspected or confirmed COVID-19 Any woman with suspected or confirmed COVID-19 should be asked to not attend the unit. If assessment is required, they must be seen in a designated COVID-19 area. Only screen-negative patients or patients with suspected COVID-19 who need to be reviewed without delay should be asked to attend the unit. If an ultrasound scan is required, we recommend that one ultrasound machine and room is designated for patients with suspected or confirmed COVID-19, if possible. It is important to clean the equipment according to safety guidelines . Any patient with a suspicion of possible SARS-CoV-2 infection must immediately be highlighted to all healthcare team members. Patients with suspicion of COVID-19 requiring admission If a patient with suspicion of COVID-19 is stable, they should be sent home to self-isolate for 7 days, if clinically appropriate. Ideally, any patient who is cohabiting with someone who shows possible symptoms of COVID-19 should self-isolate for 14 days; however, in the context of early-pregnancy care this is unlikely to be practical. Any rooms or areas in the department in which the patient was present will require deep cleaning. If the patient requires admission to the hospital, the location will depend on the reason for admission and availability of a side room until SARS-CoV-2 testing confirms their status. Any patient with a suspicion of possible SARS-CoV-2 infection must immediately be highlighted to all healthcare team members. APPOINTMENTS AND TRIAGE New appointments during normal working hours Referrals from urgent-care centers, emergency rooms, midwives and primary-care practitioners to early-pregnancy support services should be made via a dedicated phone number, if available, in order to allow telephone-based triage of both early-pregnancy symptoms and risk of COVID-19 by an experienced member of the team. If this is not possible due to logistic limitations or legal requirements, then the clinician on call to cover emergency gynecology should be contacted directly for discussion and advice. A standardized proforma should be completed to screen the patient for This article is protected by copyright. All rights reserved. Accepted Article TOCC risk factors and symptoms. The form includes three patient-specific details (name, date of birth, unique patient identifier); if a unique patient identifier is not available, then recording the patient’s address is advised (Appendix 1). This proforma can also be used to record the discussion accurately and in detail, and will determine if the patient requires urgent review or if advice can be provided remotely. This proforma is a medical record of the consultation and can be kept with the patient’s records. A basic requirement in all cases is that the woman should have a positive urine pregnancy test (UPT) in order for them to be considered for referral to early-pregnancy services. Cases of gynecological emergency, such as suspected ovarian torsion, should be discussed with the senior clinician on call. New appointments out of normal working hours (evenings, nights and weekends) Referrals should be made to the clinician on call covering emergency gynecology (if possible via telephone). This applies to out-of-hours primary-care practitioners as well as healthcare personnel working in the emergency room. Phone triage of patients should be applied as follows:  Acutely unwell patients should be advised to attend the emergency room. If they are already in the emergency room, they should be reviewed there by the responsible clinician on call for gynecology;  If ‘semi-acute’ assessment is required, the patient should be directed to a gynecology assessment unit or emergency room for review;  If the patient is stable, patient details should be collected. If possible, an experienced clinician should contact the patient by telephone for further triage assessment. Triage Ideally, triage should be performed remotely via telephone. Triage should collect the following information (Appendix 1), although this can be adapted based on available resources and infrastructure:  Unique patient identifier;  Symptoms related to COVID-19;  TOCC risk factors;  Details of presenting complaint (and advice given). Presenting complaint/request The most common presenting complaints are vaginal bleeding with or without pelvic pain. Objective measures of vaginal bleeding include a pictorial blood-loss assessment chart (Figure 1) . A visual analog score ranging from 0 to 10 (0 indicating no pain and 10 severe pain) can be used to document the level of pelvic pain. This article is protected by copyright. All rights reserved. Accepted Article Figure 1 Pictorial bleeding chart 0 – no bleeding 1 – minimal bleeding 2 – moderate bleeding 3 – soaked sanitary towel 4 – passing clots or flooding Passing clots or flooding It is important to note that if a woman presenting with vaginal bleeding and/or pelvic pain has had a previous ultrasound scan showing a normally sited pregnancy (ongoing or failed), they should first have a telephone consultation with an experienced clinician as soon as is practical, before being considered for ultrasound assessment. SYMPTOM-BASED ASSESSMENT AND FOLLOW-UP Early-pregnancy scans that need to be undertaken without delay (Appendix 4)  If a pregnant woman has pelvic pain and has not had a pelvic scan before documenting a normally sited pregnancy in the uterus, she should be invited to attend for an ultrasound scan within 24 h.  If a patient in early pregnancy has heavy vaginal bleeding (bleeding score of 3 or higher) for more than 24 h and develops symptoms due to blood loss, they should be invited to attend for an ultrasound scan within 24 h.  If a patient with risk factors for ectopic pregnancy develops symptoms (i.e. pelvic pain and/or vaginal bleeding), they should be invited to attend for an ultrasound scan within 24 h. Risk factors for ectopic pregnancy include : a) Previous ectopic pregnancy; b) Previous fallopian-tube surgery; c) Previous pelvic or abdominal surgery; d) Sexually transmitted infection; e) Pelvic inflammatory disease; f) Presence of an intrauterine contraceptive device or intrauterine system; g) Use of assisted reproductive technology. When carrying out telephone triage, clinical judgment must always be used, and if there are concerns about the patient’s clinical condition, provision should be made for immediate review. Early-pregnancy scans that can be delayed without affecting clinical care (Appendix 4)  If a patient in early pregnancy has moderate vaginal bleeding (bleeding score of 2), she can be asked to wait and repeat a UPT in 1 week: a) If the UPT is negative, no follow-up needs to be arranged; b) If the UPT is positive, an ultrasound assessment should be offered. The timing of this scan will depend on the patient’s clinical symptoms. This article is protected by copyright. All rights reserved. Accepted Article  If a patient in early pregnancy has had heavy vaginal bleeding (bleeding score of 3 or higher) which has now resolved, she can be asked to repeat a UPT in 1 week: a) If the UPT is negative, no follow-up needs to be arranged; b) If the UPT is positive, an ultrasound assessment should be offered. The timing of this scan will depend on the patient’s clinical symptoms. Early-pregnancy scans that can be avoided for the duration of the COVID-19 pandemic (Appendix 4)  Asymptomatic women in early pregnancy who request an ultrasound scan for reassurance, irrespective of risk factors.  Asymptomatic women in early pregnancy with a history of previous miscarriage(s).  Patients in early pregnancy who have minimal symptoms, such as light vaginal bleeding (bleeding score of 1) with or without mild pelvic discomfort (quantified using the visual analog scale for pelvic pain) that resolves spontaneously. Follow-up after ultrasound scan has been carried out (Appendix 5)  Live intrauterine pregnancy or intrauterine pregnancy of unknown viability: the patient should not be offered further ultrasound scans, unless it is deemed necessary clinically. Patients with a pregnancy of unknown viability can be asked to perform a UPT in 2 weeks’ time.  Pregnancy of unknown location (PUL): a blood test should be taken as per local protocol, measuring β-human chorionic gonadotropin (β-hCG) with or without progesterone. The most sensitive validated method of interpreting these results is via a two-step protocol (Figure 2) comprising initial serum progesterone level and the M6 risk prediction model, 7,8 which utilizes initial β-hCG, initial progesterone and 48-h β-hCG levels . In units in which measurement of progesterone is not part of the standard protocol, the version of the model using β-hCG alone can be used. Patients can then be managed in accordance with the model outcome and local policy. The M6 model is available to use for free online (http://earlypregnancycare.co.uk/). The model triages women with a PUL as being at high or low risk of complications as follows: a) Low-risk failing PUL: the patient should be advised to take UPT after 2 weeks; if the test is positive, they should contact the early-pregnancy unit; b) Low-risk intrauterine pregnancy: the patient should undergo a transvaginal scan after 1 week to confirm the location and viability of the pregnancy; c) High risk for ectopic pregnancy: the patient should be advised to return to the clinical unit for a repeat β-hCG measurement and ultrasound assessment after 48 h. This article is protected by copyright. All rights reserved. Accepted Article Figure 2 Proposed clinical management using the M6 model for characterization of pregnancies of unknown location (PUL) Step 1 Step 2  Nausea and vomiting in pregnancy (hyperemesis gravidarum): the patient should be assessed over the phone and advised regarding antiemetics. A validated screening tool for pregnant patients with nausea and vomiting is provided in Appendix 2 and a list of recommended antiemetic medications is provided in Appendix 3, as derived from UK guidance (and may be amended according to country or practice), for discussion over the phone . Prescriptions can be sent to primary-care practitioners or directly to the patient, if possible. If intravenous hydration is required, ambulatory departments would be an ideal location . The rare possibility of a molar pregnancy should be considered in patients with hyperemesis gravidarum and other symptoms, such as vaginal bleeding. In the event of routine dating ultrasound assessments being delayed as the clinical burden of the pandemic heightens, women should be offered assessment in early-pregnancy support services if gestational trophoblastic disease is suspected.  Ectopic pregnancy: patients should be managed in accordance with local protocols, with an emphasis on conservative management, if possible. Accurate diagnosis of an ectopic pregnancy is critical for guiding management; thus, ultrasound scans should be reviewed by the most senior clinician available. In the event that a senior clinician is at home self- isolating or not in the hospital, consideration should be given to allow review of ultrasound images online, with appropriate security. Suggestions and important good practice points relating to management of patients with an ectopic pregnancy include: This article is protected by copyright. All rights reserved. Accepted Article a) Expectant management: ensure appropriate follow-up, reduce contact with the patient as much as possible, limit the number of ultrasound scans and perform β- hCG monitoring if possible. b) Medical management: the commonly used medication is the antimetabolite methotrexate . Body surface area is used to calculate dosing. There is a known low risk of immunosuppression with use of methotrexate . It is currently unknown whether immunosuppression increases the effect of SARS-CoV-2 infection and whether administering such medication in SARS-CoV-2-positive patients exacerbates pneumonia-related complications. It is likely that the detrimental effects of methotrexate in patients with COVID-19 are minimal, but this possibility must be considered and medical treatment should be discussed with a senior clinician and reviewed in a multidisciplinary meeting. Screening of women prior to administration of methotrexate can be considered depending on local hospital policy. c) A joint statement by the UK Royal Colleges of Surgeons has stated that laparoscopy 13,14 should be carried out only in selected situations during the COVID-19 pandemic . Other national bodies, such as the British Society of Gynaecological Endoscopy and the Royal College of Obstetricians and Gynaecologists, permit the use of laparoscopy but with necessary precautions. There is limited evidence on the risk of SARS-CoV-2 infection during laparoscopy; therefore, during laparoscopic surgery, strict precautions should be taken to filter CO escaping into the operating theatre and the theatre staff should wear appropriate PPE . Laparotomy should be considered as an alternative to laparoscopy if these strict precautions cannot be met confidently.  Miscarriage: patients should be managed in accordance with local protocols. Counseling should be offered and performed over the phone, if possible. However, there should be an effort to reduce inpatient admissions; ideal options are medical management and use of manual vacuum aspiration if available in the local unit : a) Women undergoing expectant or medical management do not need to be offered further ultrasound scans, but should be asked to carry out a UPT in 3 weeks. If the diagnosis is made in hospital, patients should be provided with adequate analgesia, such as combined paracetamol and codeine preparations. Units should aim to provide telephone consultation to women 3 weeks following their miscarriage to assess physical and emotional wellbeing, if resources are available. b) The availability of surgery will need to be reviewed locally on a daily basis, and if surgical management is indicated, appropriate precautions related to surgery and PPE must be taken. If appropriate and available, manual vacuum aspiration should be performed to reduce the risk and required resources associated with general anesthesia. SCHEDULING AND ORGANIZING APPOINTMENTS This article is protected by copyright. All rights reserved. Accepted Article Pre-existing appointments  A review of the clinical urgency of all existing appointments should be made by the medical team on a weekly basis;  All non-urgent scans should be postponed for (at least) 14 days and organized according to the recommended schemes of essential care;  For routine or non-urgent appointments, women should be advised by phone that their pregnancy care will not be compromised but will be modified to keep her and her baby safe during the SARS-CoV-2 outbreak. Women should be advised not to attend the hospital, and to self-isolate for 14 days if appropriate, based on local and national guidelines. Precautions that should be taken in the waiting areas and examination rooms 1. Considering the recommendation for social distancing, it is important to respect the time of scheduled visits, to space out the appointment intervals in order to prevent crowding in the waiting room and to space the seats in the waiting areas to at least 2 meters apart. 2. Hand sanitizer should be made available at the entrance to and within the waiting rooms. Pregnant patients and their partners (if present) should be advised to use it immediately upon arrival, at frequent intervals during their stay in the department and prior to the ultrasound scan. If hand sanitizer is not available due to shortage, women should be advised to wash their hands with soap for a minimum of 20 sec prior to the scan. 3. Facemasks must be made available and used according to previously published guidance . Specifically, patients with symptoms or judged to have suspected or probable COVID-19 should wear a surgical mask. Sonographers should wear a surgical facemask or respirator (N95, FFP2, FFP3) depending on the risk profile of the patient. 4. Patients should be asked, when arranging their appointment, to either attend on their own or with only one other adult. No children or adult over the age of 60 years should attend the appointment. Women with symptoms suggestive of possible SARS-CoV-2 infection should avoid visiting the unit, unless there is a strong clinical indication for a visit. In such circumstances, the woman should be seen and assessed in a designated ‘contaminated’ area or SARS-CoV-2 assessment area. Guidance for staff undertaking routine or specialist ultrasound scans 1. Guidance on cleaning and disinfection of ultrasound transducers and equipment, and how to protect the patients and ultrasound providers during obstetric and gynecological scans, has been provided in a separate document . 2. All recommendations from local infection-control departments should be followed, including:  The sonographer’s arms should be bare below the elbows;  The sonographer should not wear a watch or any jewelry. 3. Practitioners should wash their hands or use hand sanitizer both before and after direct patient contact. 4. Practitioners should use latex-free disposable gloves during the ultrasound examination and change after each patient. 5. We recommend the use of a three-ply surgical mask as a minimum when performing ultrasound scans, as sonographers spend a significant time during an examination in close This article is protected by copyright. All rights reserved. Accepted Article proximity to the patient. When managing patients with suspected/probable/confirmed COVID-19, an appropriate respirator should be used (N95, FFP2, FFP3) . 6. The use of single-use gel packs is recommended, instead of gel containers, even for transabdominal scans. 7. Non-clinical staff (e.g. receptionists and clerks) are advised to follow local infection-control procedures. If they are able to perform their tasks without being in close proximity to patients, use of a three-ply surgical mask should not be necessary. 8. All personnel working in ultrasound units should be aware of the potential symptoms of SARS- CoV-2 infection, such as new onset of cough, fever and shortness of breath. If they develop any of these symptoms, they should immediately seek medical advice and arrange testing, if allowed by local protocols. Coordinating your local unit during the COVID-19 pandemic In addition to the usual day-to-day requirements for running your local unit, we recommend the following:  All PPE must be checked daily to ensure your unit is stocked and prepared;  All staff must be fit tested for FFP3 masks and records must be kept;  Managers should anticipate that staff (or members of their family) may become unwell during the pandemic, and therefore, careful planning of staff and contingency planning should be carried out in accordance with local availability;  If patients are tested for SARS-CoV-2, ensure that records of the tests sent are kept and that these results are checked daily. Ensure that the patient is informed of the result, and if they were admitted, the ward staff and team in the hospital are also informed as soon as possible;  If multidisciplinary team meetings (MDT) are relevant to practice, we highly encourage units to conduct weekly MDT, which can be arranged using an online meeting platform (e.g. Zoom), to discuss cases;  Considering that there is a high risk of SARS-CoV-2 transmission between staff, social distancing with colleagues should be observed when possible and meetings should be kept to the minimum necessary. Meal breaks should be taken in isolation and not as a group. This article is protected by copyright. All rights reserved. Accepted Article REFERENCES 1. Abramowicz JS, Basseal JM, Brezinka C, Dall’Asta A, Deng J, Harrison G, Marsal K, Lee JCS, Lim A, Miloro P, Poon LC, Salvesen KJ, Sande R, ter Haar G, Westerway SC, Xie MX, Lees C. ISUOG Safety Committee Position Statement on use of personal protective equipment and hazard mitigation in relation to SARS-CoV-2 for practitioners undertaking obstetric and gynecological ultrasound. Ultrasound Obstet Gynecol 2020. https://www.isuog.org/uploads/assets/b8dde768-08a2-424c- a4615551637515e9/ISUOG-Safety-Committee-statement-on-COVID19-and-PPE.pdf 2. Bourne T, Leonardi M, Kyriacou C, Al-Memar M, Landolfo C, Cibula D, Condous G, Metzger U, Fischerova D, Timmerman D, van den Bosch T. ISUOG Consensus Statement on rationalization of gynecological ultrasound services in context of SARS-CoV-2. Ultrasound Obstet Gynecol 2020. https://www.isuog.org/resource/isuog-consensus-statement-on-rationalization-of- gynecological-ultrasound-services-in-context-of-sars-cov-2.html 3. Guan WJ, Ni ZY, Hu Y, Liang W, Ou C, He J, Liu L, Shan H, Lie C, Hui D, Du B, Li L. Clinical Characteristics of Coronavirus Disease 2019 in China. NEJM 2020. DOI: 10.1056/NEJMoa2002032 4. Poon LC, Abramowicz JS, Dall’Asta A, Sande R, ter Haar G, Marsal K, Brezinka C, Miloro P, Basseal J, Westerway SC, Abu-Rustum RS. ISUOG Safety Committee Position Statement: safe performance of obstetric and gynecological scans and equipment cleaning in the context of COVID-19. Ultrasound Obstet Gynecol 2020. DOI: 10.1002/uog.22027. 5. Herman MC, Mak N, Geomini PM, Winkens B, Mol BW, Bongers MY. Is the Pictorial Blood Loss Assessment Chart (PBAC) score associated with treatment outcome after endometrial ablation for heavy menstrual bleeding? A cohort study. BJOG 2017; 124: 277–282. 6. The American College of Obstetricians and Gynecologists. Ectopic Pregnancy. 2018. https://www.acog.org/patient-resources/faqs/pregnancy/ectopic-pregnancy. 7. Bobdiwala S, Saso S, Verbakel JY, Al-Memar M, Van Calster B, Timmerman D, Bourne T. Diagnostic protocols for the management of pregnancy of unknown location: A systematic review and meta-analysis. BJOG 2019; 126: 190–198. 8. Bobdiwala S, Christodoulou E, Farren J, Mitchell-Jones N, Kyriacou C, Al-Memar M, Ayim F, Chohan B, Kirk E, Abughazza O, Guruwadahyarhalli, Guha S, Vathanan V, Bottomley C, Gould D, Stalder C, Timmerman D, Van Calster B, Bourne T. Triaging women with pregnancy of unknown location using two-step protocol including M6 model: clinical implementation study. Ultrasound Obstet Gynecol 2020; 55: 105–114. 9. Royal College of Obstetricians and Gynaecologists. The Management of Nausea and Vomiting of Pregnancy and Hyperemesis Gravidarum Green top guideline No 69. 2016. https://www.rcog.org.uk/globalassets/documents/guidelines/green-top-guidelines/gtg69- hyperemesis.pdf 10. Mitchell-Jones N, Farren J, Tobias A, Bourne T, Bottomley C. Ambulatory versus inpatient management of severe nausea and vomiting in pregnancy: A randomized control trial with patient reference arm. BMJ Open 2017; 7: e017566. 11. National Institute for Health and Care Excellence. Ectopic pregnancy and miscarriage: diagnosis and initial management. NICE Guideline. 2019. https://www.nice.org.uk/guidance/ng126 12. British National Formulary. Methotrexate. 2020. https://bnf.nice.org.uk/drug/methotrexate.html 13. Society of American Gastrointestinal and Endoscopic surgeons. Update to SAGES recommendations regarding surgical response to COVID-19 crisis. 2020. https://www.sages.org/update-to-sages-recommendations-regarding-surgical-response-to- This article is protected by copyright. All rights reserved. Accepted Article covid-19-crisis/ 14. The Royal College of Surgeons of Edinburgh. Intercollegiate General Surgery Guidance on COVID- 19. 2020. https://www.rcsed.ac.uk/news-public-affairs/news/2020/march/intercollegiate- general-surgery-guidance-on-covid-19-update 15. Zheng MH, Boni L, Fingerhut A. Minimally invasive surgery and the novel coronavirus outbreak: lessons learned in China and Italy. Ann Surg 2020. DOI: 10.1097/SLA.0000000000003924. 16. National Institute for Health and Care Excellence. Doxylamine/pyridoxine (Xonvea) for treating nausea and vomiting of pregnancy. Evidence summary. 2019. https://www.nice.org.uk/advice/es20/chapter/Key-messages This article is protected by copyright. All rights reserved. Accepted Article AUTHORS T. Bourne, Tommy’s National Centre for Miscarriage Research, Queen Charlotte’s and Chelsea Hospital, Imperial College, London, UK; Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium; KU Leuven, Department of Development and Regeneration, Leuven, Belgium C. Kyriacou, Tommy’s National Centre for Miscarriage Research, Queen Charlotte’s and Chelsea Hospital, Imperial College, London, UK A. Coomarasamy, Tommy’s National Centre for Miscarriage Research, Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, UK M. Al-Memar, Tommy’s National Centre for Miscarriage Research, Queen Charlotte’s and Chelsea Hospital, Imperial College, London, UK M. Leonardi, Acute Gynecology, Early Pregnancy & Advanced Endoscopic Surgery Unit, Sydney Medical School Nepean, University of Sydney Nepean Hospital, Penrith, Sydney, Australia E. Kirk, Early Pregnancy and Acute Gynaecology Unit, Royal Free NHS Foundation Trust, London, UK C. Landolfo, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Dipartimento Scienze della Salute della Donna, del Bambino e di Sanità Pubblica, Rome, Italy M. Blanchette-Porter, Larner College of Medicine at University of Vermont Obstetrics, Gynecology, and Reproductive Sciences Division, Reproductive Medicine and Infertility Burlington, Vermont, USA R. Small, Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust, Bordesley Green East, Birmingham, UK G. Condous, Acute Gynecology, Early Pregnancy & Advanced Endoscopic Surgery Unit, Sydney Medical School Nepean, University of Sydney Nepean Hospital, Penrith, Sydney, Australia D. Timmerman, Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium; KU Leuven, Department of Development and Regeneration, Leuven, Belgium This article is protected by copyright. All rights reserved. Accepted Article Appendix 1 Checklist for symptoms and TOCC Patient name: Patient date of birth: Patient unique patient identifier (UPI): Patient address (if UPI not available): 1 Influenza-like illness symptoms Fever  Droplet Precautions Cough for patient with respiratory symptoms Sore throat Shortness of breath Diarrhea and/or vomiting  Contact Precautions None of above Information cannot be obtained 2 TOCC: 14 days before onset of symptoms History of recent Travel * If influenza-like-illness Date of travel: from to symptoms +ve plus Area: TOCC +ve High risk Occupation (e.g. laboratory workers, healthcare workers, wild animals related work)  Prompt isolation  Airborne, Droplet History of unprotected Contact with: & Contact a Human case confirmed with COVID-19, OR Precautions b Consumption of wild animals in areas known to have COVID-19 Clustering of influenza-like illness / pneumonia (≥ 2 affected persons) None of above Information cannot be obtained 3 Types of Isolation Precautions required: Droplet Precautions Contact Precautions Airborne Precaution Nil Reason for referral/call and advice given: Date: Name & Signature: Designation: Droplet precautions: put a mask on the patient; single room; healthcare worker uses PPE appropriately, including a mask, upon entry to room. Contact precautions: single room; healthcare worker uses PPE appropriately upon entry to room, including gloves and gown; use disposable equipment. Airborne precautions: put a mask on the patient; negative-pressure isolation room; healthcare worker uses PPE appropriately upon entry to room, including wearing a fit-test approved respirator, gloves, gown, face and eye protection; negative-pressure isolation room; restrict susceptible healthcare workers from entering the room; use disposable equipment. This article is protected by copyright. All rights reserved. Accepted Article Appendix 2 Early pregnancy hyperemesis rapid assessment tool Pregnancy Unique Quantification of Emesis (PUQE) scoring system Complete for all patients presenting with nausea and vomiting in early pregnancy 1. In the last 12 hours, for how long have you felt nauseated or sick to your stomach? More than Not at all 1 hour or less 2–3 hours 4–6 hours 6 hours Score=1 Score=2 Score=3 Score=4 Score=5 2. In the last 12 hours have you vomited or thrown up? 7 or more times 5–6 3–4 1–2 I did not throw up Score=5 Score=4 Score=3 Score=2 Score=1 3. How many times have you had retching or dry heaves without bringing anything up? None 1–2 3–4 5–6 7 or more Score=1 Score=2 Score=3 Score=4 Score=5 Score interpretation Mild nausea and vomiting of pregnancy Offer antiemetics as per protocol Score < 6 Advise to return if symptoms worsen Moderate nausea and vomiting of pregnancy Offer antiemetics as per protocol Score 7–12 Advise to return if symptoms worsen Severe nausea and vomiting/hyperemesis gravidarum Requires secondary care level treatment: refer to gynecology team Score ≥ 13 Ambulatory care if available This article is protected by copyright. All rights reserved. Accepted Article 9, 16 Appendix 3 Recommended medication for management of nausea and vomiting in early pregnancy Drug Mode of action Dosing/administration Safety Side effects First Line Cyclizine Antihistamine Oral/IV/IM/PR Well established safety profile in Sedation. Anticholinergic side effects H1 receptor antagonist 50mg 8 hourly, Slow IV injection. pregnancy (tachycardia, dry mouth, dizziness, Anticholinergic properties SC infusion (150mg over 24 No evidence of teratogenicity constipation, blurred vision), hours) euphoric/hallucinogenic effects Xonvea Antihistamine Oral Established as safe Sedation, anticholinergic side effects (doxylamine with pyridoxine H1 receptor antagonist Diclectin: 10mg doxylamine + Previous concerns over increased (B6) ) Anti-emetic action of pyridoxine 10mg. 2-4 Tablets per risk of birth defects disproven pyridoxine unclear day in divided doses Prochlorperazine Phenothiazide Oral: 5-10mg TDS Well established safety profile in Extrapyramidal side effects Dopamine antagonist Sublingual: 3-6mg BD pregnancy IM injection:12.5mg TDS No evidence of teratogenicity Second Line Metoclopramide Combined dopamine and 5- Oral/IV/IM Well established safety profile in Extrapyramidal side effects (acute hydroxytriptamine (5-HT) 10mg three times daily pregnancy dystonias, oculogyric crisis). Should antagonist Subcutaneous infusion 30-100mg No evidence of teratogenicity be prescribed for short periods, in 24 hours maximum 5 days advised by IV doses over at least 3 minutes European Medicines Agency Ondansetron 5-HT type 3 receptor Oral/IV/IM/PR/SL Has been linked with oral facial Constipation, flushing, arrhythmias antagonist which acts both 4-8mg three times daily defects (cleft lip/palate). The Prolonged Q-T syndrome (higher risk centrally and peripherally Subcutaneous infusion up to largest observational studies with associated electrolyte 32mg in 24 hours suggest no evidence of imbalance) teratogenicity or adverse pregnancy effects This article is protected by copyright. All rights reserved. Accepted Article Appendix 4 Flowchart summarizing recommended rationalization of early-pregnancy management including ultrasound scans (USS), based on symptoms, in context of COVID-19 pandemic Positive UPT Bleeding score Risk factors of Bleeding score Asymptomatic Light bleeding Pelvic pain - >3 for > 24 h ectopic Asymptomatic Bleeding score >3 but (history of +/- pain not no previous and pregnancy (for bleeding previous troublesome symptomatic and pain +/- 0 reassurance) scan settled miscarriage) to patient of anemia bleeding Not for scan. Not for scan. Wait, repeat Refer to Refer to Offer USS UPT in antenatal antenatal within 24 h 1 week services services To call if If UPT+, offer symptoms USS persist/recur This article is protected by copyright. All rights reserved. Accepted Article Appendix 5 Flowchart summarizing recommended rationalization of early-pregnancy follow-up based on initial ultrasound scan (USS) findings, in context of COVID-19 pandemic ​A & E PUV - Pregnancy of u nkn own viab ility GP PUL - Pregnancy of unknown location Other referrals EPU - Early Pregnancy Unit PPE - Person al pro tective equipment UPT - Urinary pr egnanc y test MVA - Manu al vacuu m asp ir atio n ​Telephone Triage (dedicated number in the day-time, and oncall doctor at night or weekend) ​Decide on CO VID19 risk Decide on urgency High risk for Apparent low ris k COVID19 or for COVID19 confirmed case​ Telephone a dvice or s ee Telephone a dvice or s ee patient in a dedicated patient in EPU COVID19 area​ Use COV ID19- ​Wa sh ha nds or specific USS use s anitizer See very Consult by machine See within 7 soon (within telephone only Use appropriate days if 24 hours) +/- (no need for Use PPE PPE necessary scan (use clinical scan) judgement) Abdominal or pelvic pa in ​Light PV bleeding +/- Moderate PV mild pain in early pregnancy​ bleeding, or heavy PV bleeding that has Hyperemesis Any symptoms of ectopic settled: pregnancy + risk factor(s) UPT in 1 week; for ectopic pregnancy if +, for TVS Excessive bleeding in early pregnancy Pelvic Ultrasound Follow ISUOG practica l Live pregnancy or No further scans guidance on PUV PUV - UPT in 2 weeks scanning ​Expectant Incomplete: Expectant management or management Miscarriage Methotrexa te or Missed: Medical La paroscopy or management or MVA​ La parotomy Ectopic pregnancy PUL Consider RCS and BSGE/ RCO G guidelines f or PUL - use M6 model la paroscopy www.earlypregna ncycare.co.uk This article is protected by copyright. All rights reserved. Accepted Article

Journal

Ultrasound in Obstetrics & GynecologyPubmed Central

Published: Apr 8, 2020

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