key: cord-0851750-nt5omngy authors: Pavlidis, Pollyanna; Eddy, Katherine; Phung, Laura; Farrington, Elise; Connolly, Mairead; Lopes, Rudy; Wilson, Alyce N.; Homer, Caroline S.E.; Vogel, Joshua P. title: Clinical guidelines for caring for women with COVID-19 during pregnancy, childbirth and the immediate postpartum period date: 2020-11-03 journal: Women Birth DOI: 10.1016/j.wombi.2020.10.015 sha: a4cd4757990dcdacdff3bd52961647e37fde4081 doc_id: 851750 cord_uid: nt5omngy Background The spread of the novel coronavirus (COVID-19) was declared a pandemic by the World Health Organization on 11th March 2020. Since then there has been a rapid rise in development of maternal and perinatal health guidelines related to COVID-19. The aim of this project was to develop a database of Australian and international recommendations relating to antenatal, intrapartum and postpartum care of women during the COVID-19 pandemic, in order to identify inconsistencies in clinical guidance. Methods : We conducted weekly web searches from 30th March to 15th May 2020 to identify recommendations pertaining to the care of women during pregnancy, labour and postpartum period from national or international professional societies, specialist colleges, Ministries of Health, Australian state and territory governments, and international guideline development organisations. Individual recommendations were extracted and classified according to intervention type, time period, and patient population. Findings were reported using descriptive analysis, with areas of consensus and non-consensus identified. Results We identified 81 guidelines from 48 different organisations. Generally, there was high consensus across guidelines for specific interventions. However, variable guidance was identified on the use of nitrous oxide during labour, administration of antenatal corticosteroids, neonatal isolation after birth, labour and birth companions, and the use of disease modifying agents for treating COVID-19. Conclusion Discrepancies between different guideline development organisations creates challenges for maternity care clinicians during the COVID-19 pandemic. Collating recommendations and keeping up-to-date with the latest guidance can help clinicians provide the best possible care to pregnant women and their babies. In December 2019 a pneumonia of unknown cause was detected in Wuhan, China and reported to the World Health Organization (1) . The novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was found to be the causative agent, and the disease subsequently named COVID-19 (2) . The World Health Organization declared the outbreak a pandemic on 11th March 2020. As of 9th July 2020, there have been over 11 million confirmed cases of COVID-19 globally, and over 540,000 deaths (3) . Available data on the effect of COVID-19 on pregnancy, pregnant women, and newborns is limited (4) . Current information suggests pregnant women are not at higher risk of severe illness than the general population (4) . A systematic review identified 33 studies which reported on the outcomes of 385 pregnant women with COVID-19, of whom 368 (95.6%) were considered to have mild disease (5) . Amongst 256 newborns the prevalence of preterm birth was 15.2% and low birth weight was 7.8%. Eight (3.1%) newborns required admission to neonatal intensive care and 3 deaths occurred. The extent to which maternal COVID-19 infection contributed to these perinatal outcomes is unclear. In the case of COVID-19 -a novel disease where new evidence is emerging daily -up-to-date clinical guidelines are vital in providing clinicians and other stakeholders with recommendations based on the latest available evidence. A considerable volume of guidance relating to care of pregnant women with COVID-19 has been rapidly developed and published. In some instances, clinical recommendations from different organisations are in conflict, which can create confusion for healthcare providers. We aimed to develop a database of national and international guidelines related to the antenatal, intrapartum and postpartum care of women during the COVID -19 pandemic and identify those interventions where there was high and low consensus across recommendations. J o u r n a l P r e -p r o o f We developed a study protocol to guide literature searching and data extraction. We aimed to identify and include any guidance that provided clinical recommendations or normative statements related to the clinical care of women during pregnancy, labour, childbirth or the postpartum period in the context of the COVID-19 pandemic. Guidelines of interest were those developed specifically in response to or where the recommendations pertained to changes to routine care in the context of treating COVID-19. We included guidelines produced either at international, national or Australian state or territory levels. Guidelines produced from reputable guideline development organisations such as national or international professional societies or specialty colleges, Governmental departments or Ministries of Health or international agencies were included. Guidelines published prior to 2020 pertaining to other respiratory illnesses or infections were not eligible. First, we developed a list of relevant guideline development organisations and searched their institutional websites directly. This was supplemented with structured searches for clinical guidelines via the Trip database, using the 'guideline' filter and search terms pregnancy, childbirth, postpartum (and related terms) and COVID-19 (6).We also contacted international collaborative networks to identify further eligible resources. For the period of 30th March to 15th May 2020, weekly searches of all identified websites and Trip were conducted to identify new guidelines or updates of existing guidelines. On 17th April 2020, we published a list of included guidelines on the Burnet website (7) . Web visitors were invited to suggest additional guidelines or resources for consideration via an online form. J o u r n a l P r e -p r o o f All identified guidelines were initially screened by one reviewer to assess eligibility. For eligible guidelines, each recommendation pertaining to management of pregnancy, labour, childbirth and the immediate postpartum period for women in the context of the COVID-19 pandemic were extracted. Each guideline was reviewed by two independent reviewers. Individual recommendations were extracted and classified them according to intervention type, period (preconception, antenatal, intrapartum, postpartum, all periods, unspecified) and population (e.g. women, healthcare providers or newborns). Recommendations for women and newborns were classified differently depending on whether they were regarding care of the general population, or specifically those with suspected or confirmed COVID-19. Where one recommendation included the use of two (or more) interventions, it was extracted twice (or more) and classified accordingly. Disagreements between reviewers were resolved through discussion or consultation with a third reviewer. If a guideline was updated, we updated the data extraction accordingly, with superseded or outdated recommendations removed from the database. While standardised guideline quality assessment tools (such as the AGREE II tool) exist, the majority of guidelines identified in our searches were produced rapidly without the customary documentation of the evidence synthesis and guideline development process. This lack of information makes it difficult to properly (and consistently) assess guideline quality. We therefore decided against a formal quality assessment of individual guidelines. For two guidelines that were not in English (French and Italian) we used a combination of colleagues familiar with these languages plus Google Translate to translate relevant recommendations into English for analysis. From the data we identified a list of 91 specific interventions, grouped under 18 intervention types, for which at least one recommendation was available. A full list of this interventions can be found on J o u r n a l P r e -p r o o f the Burnet website (www.burnet.edu.au/projects/435_). This list was reviewed and discussed by the review team, in consultation with three specialists in obstetrics, gynaecology and midwifery, in order to identify a shortlist of priority topics (Box 1). Priority topics were those considered most important from a clinical care perspective and/or where lower consensus was anticipated. We then prepared a detailed table of all recommendations relating to this shortlist of priority topics. A narrative summary of each priority topic was prepared by the review team based on these findings, in order to qualitatively assess the degree of consensus. There were 87 recommendations across 40 guidelines (from 28 organisations) regarding the presence of a support person and birth and appointments for all pregnant women, and infection control policies for these visitors. There was general consensus that the number of visitors for women in hospital should be restricted, with some guidelines suggesting a limit of one visitor per day (4, 8, 10, 13, 16, 17, 19- There was no consensus between guidelines regarding birth companions. Eight guidelines indicated that women -irrespective of COVID-19 status -should be allowed and encouraged to have a companion present, provided the companion is asymptomatic (13, 18, 45, 50, 58, 62, 66) . However, three guidelines from Sri Lanka (57), Italy (Capanna et al.) (87) and FIGO and allied partners (75) advised that no birth partners should be allowed for women with suspected or confirmed COVID -19. There was consensus that individuals who are symptomatic or confirmed to have COVID-19 should not be allowed to visit a hospital (4, 10, 13, 23, 54, 66, 80) and that all support persons should be screened prior to presenting to a facility (34, 40, 45, 66, 80) . Regarding appointments, some guidelines stated it is preferable that women attend alone, however if necessary for support or care then a maximum of one visitor may be allowed (18, 25, 47, 48, 61, 66) . There were 29 guidelines from 27 organisations which provided 37 recommendations regarding the use of antenatal corticosteroids (both betamethasone and dexamethasone) for preterm birth in women with COVID-19 infection. There was disagreement between guidelines as to whether corticosteroids should be given when usually recommended. While some guidelines recommended that steroids should be given where usually indicated (8, 13, 23, 45, 52, 53, 57, 65, 66, 81) , others suggested there should be more careful assessment of the balance between maternal risks and neonatal benefit, and that it should be discussed with maternal-fetal, neonatal and infectious disease specialists in light of evidence suggesting harm to the patient with severe COVID-19 (35, 61, 62, 64, 73-75, 77, 83, 85, 87, 88) . Three guidelines from Western Australia (17), Queensland (13) and Ireland (58) recommended that while COVID-19 infection itself is not an indication to alter the provision of antenatal corticosteroids, in those with moderate to severe disease the administration of antenatal corticosteroids should be discussed with specialists in light of the maternal risks. Two guidelines from the USA (37, 44) suggested that antenatal corticosteroids could be given up until 34 weeks' gestation, as at later gestations the benefits may not outweigh the potential risks to a COVID-19 positive patient with moderate to severe disease. There were 115 recommendations from 38 guidelines (32 organisations) regarding the mode of birth for women with COVID-19. The majority of these were regarding the decision between a caesarean or vaginal birth (53 recommendations). Others pertained to instrumental birth, induction of labour, the timing of birth and guidelines for performing a caesarean section such as PPE and the number of theatre staff. There was general consensus that the mode of birth should not be influenced by maternal COVID-19, unless urgent birth is required due to the mother's respiratory condition (4, 8, 10, 13, 17, J o u r n a l P r e -p r o o f 21, 23, 37, 44, 45, 57-59, 61, 62, 64, 73-81) . In the case of rapid maternal deterioration, guidelines advise an individual assessment and treatment of the patient (17, 45, 87) and caesarean section may be required (10, 75, 83, 86) . Alternatively, if the woman delivers vaginally and is short of breath, some guidelines suggest instrumental birth may be required to shorten the length of the second stage of labour (8, 74, 75, 86) . However, two guidelines suggested that there may be a greater need There were 26 guidelines from 23 different organisations which offered 80 recommendations regarding labour analgesia for all women including regional and general anaesthesia (45 recommendations), water immersion/birthing pools (10 recommendations) and nitrous oxide (23 recommendations). There was disagreement between guidelines as to whether to use nitrous oxide. Several guidelines suggested that given the insufficient information as to whether or not nitrous oxide is an aerosol generating procedure it should be avoided in women with suspected or confirmed COVID-19 (4, 12, J o u r n a l P r e -p r o o f 13, 17, 22, 33, 60). Others suggested that nitrous oxide was safe to give all pregnant women, provided it was used with a single-patient microbiological filter (10, 23, 45, 51, 58) . One guideline from the UK indicated that nitrous oxide use was not an aerosol-generating procedure, however it did not provide a recommendation as to its safety in COVID-19-positive women (52). Other guidelines from the USA indicated that its use and potential suspension should be discussed within individual labour and delivery units (34, 35, 37) , or that it may be a source of cross-infection, and that it is important staff are aware of the appropriate decontamination guidelines (83) . There was consensus that regional anaesthesia should continue to be used normally (4, 8, 12, 22, 34, 45, 51, 62) . Although both regional and general anaesthesia may be considered (74, 75, 81, 82), regional anaesthesia is preferred to general anaesthesia, unless it is unavoidable (22, 51, 57, 58, 60, 75) . Several guidelines indicated that early epidural anaesthesia in labour should be considered to minimise need for general anaesthesia (12, 13, 17, 23, 35, 45, 51, 58) , and also as an alternative to nitrous oxide in women who are COVID-19 positive (12) . Three guidelines indicated that in women with COVID-19 the platelet count should be checked prior to spinal/epidural, considering that thrombocytopenia is a common finding in people with COVID- 19 (22, 51, 58) . When general anaesthesia is used, guidelines recommend it should be done under negative pressure (45) , by experienced anaesthetists with adequate PPE (57, 58). There was general consensus that birthing pools (i.e. giving birth while immersed in water) should be avoided in women with COVID-19 due to the risk of infection to the newborn and healthcare workers (13, 17, 23, 45, 58, 74, 75). However, RANZCOG (4, 12) has indicated that water immersion may continue to be used in the normal manner. It is unclear as to whether this recommendation also includes women who are COVID-19 positive. There were 20 guidelines from 18 organisations which gave 23 recommendations regarding cord clamping. There was no consensus between guidelines surrounding whether delayed cord clamping is appropriate in women with COVID-19. While many guidelines suggest that delayed cord clamping safe to continue given the lack of evidence to suggest otherwise (8, 12, 13, 17, 23, 37, 45, 52, 53, 85) , others recommended it may be best avoided (58, 65, 74, 75, 80, 81, 83, 87) . One guideline from Ireland (58) suggested that delayed cord clamping might be appropriate for preterm neonates less than 32 weeks' gestation, but should not be routinely done for babies born at a later gestation. There were 21 recommendations in 17 guidelines (from 16 organisations) regarding skin-to-skin contact between mothers and newborns after birth. There was consensus that skin-to-skin should continue regardless of maternal COVID-19 infection, provided appropriate PPE is worn (12, 15, 17, (87) recommended that early skin-toskin contact be avoided in mothers with COVID-19, although they did not provide evidence that skinto-skin transmission of COVID-19 occurs. In total, 32 guidelines (27 organisations (80) suggested that rooming-in be undertaken for stable neonates, but if there are available resources for isolation then separation should be favoured. It was suggested that in the event of rooming-in, when a mother has COVID-19, measures should be taken to reduce transmission, for example using PPE or a curtain between mother and newborn and attention to strict hand hygiene measures (35, 40, 58, 71, 74, 75) . In total, 52 guidelines from 41 different organisations had 121 recommendations related to breastfeeding. There was consensus that breastfeeding is safe and important to continue, regardless of the woman's COVID-19 status, and if a woman was well enough to breastfeed she should be encouraged to do so (8, 10, 12-15, 17, 19, 21, 23, 29, 31, 41, 45, 53, 54, 56, 58, 62-64, 66, 67, 71, 73, 76, 78-80) . However, three guidelines from Malaysia (60), China (Chen et al.) (81) and Favre et al (86) advised against direct breastfeeding in mothers with COVID-19, however no evidence was provided to support these recommendations. Several guidelines indicated that while there is currently no evidence that the virus can be transmitted through breastmilk, there is a risk of transmission from mother to baby during breastfeeding via respiratory droplets. Guidelines consequently emphasised the need for mothers with suspected or confirmed COVID-19 to wear a face mask and to practice hand hygiene while J o u r n a l P r e -p r o o f breastfeeding (8, 9, 16, 17, 23, 29, 31, 35, 38, 40, 41, 45, 46, 53, 54, 56, 58, 59, 62, 63, 66, 67, 71, 73-75, 79-81, 83, 85) . Additionally, there was consensus that if women are not well enough to breastfeed, or if temporary separation is undertaken due to maternal COVID-19 infection, they should still be encouraged to express milk which can safely be provided to their newborn (10, 15, 17, 23, 29, 39, 54, 58, 62, 63, 66, 67, 71, (73) (74) (75) (76) 80) . One guideline from the UK (52) suggested that given the overwhelming benefits of breast milk to the infant, unwell COVID-19 positive women who are required to withhold breastfeeding are encouraged to express their breastmilk and discard it in order to maintain lactation until she is no longer infectious. There was general consensus that given the association of fluid overload and Acute Respiratory Distress Syndrome, women with moderate and severe disease require close fluid balance monitoring (8, 13, 17, 45, 58, 66, 75) . Several noted critically ill pregnant patients without shock should be J o u r n a l P r e -p r o o f managed with conservative fluid management (74, 81). Additionally, there was consensus that oxygen saturations should be monitored closely (17, 45, 74, 75, 80, 81) and hypoxia should be avoided, with the aim of maintaining target oxygen saturation >92% (8, 13, 44, 45, 57, 58, 74, 75, 80, 81) . However, there was some variation on the actual target level of oxygen saturation (>92-95%). One guideline from the USA specified that while the recommended target oxygen saturation for non-pregnant women with COVID-19 is >92%, for pregnant women oxygen saturation should aim for >95% (44). There were 27 recommendations in 15 guidelines from 15 different organisations regarding antibiotic use. There was general consensus that antibiotics should only be commenced in women with COVID-19 if there was evidence of secondary bacterial infection (17, 53, 58, 61, 62, 65, 74, 75, 81, 89) , and that antibiotic therapy should be discussed with infectious diseases specialists (13, 17, 64, 74, 75). However, three guidelines from India (62, 80) and the Philippines (61) suggested that azithromycin could be used for the specific treatment of COVID-19, however there is no evidence to support these recommendations. Eleven guidelines (11 organisations) made 27 recommendations regarding antiviral and other disease modifying treatments for COVID-19. Some guidelines specified that the use of antivirals in a pregnant woman with COVID-19 must be done in consultation with a virologist prior to initiating therapy and on a case-by-case basis (65, 74, 75). Others gave suggestions regarding possible dosing regimens for hydroxycholoroquine (58, 59, 62, 80, 83) , lopinavir and ritonavir (58, 59, 80, 81) , remdesivir (58, 59) , oseltamivir (62) and the immunosuppressive agent tocilizumab (58). Six guidelines (five organisations) provided 17 recommendations regarding anticoagulation for COVID-19 positive pregnant patients. Most recommended that both antenatal and postnatal venous thromboembolism prophylaxis be considered for pregnant women with COVID-19 irrespective of disease severity (13, 45, 58, 75) , while two recommended that all COVID-19-positive women be discharged home postnatally with prophylactic low molecular weight heparin (45, 58) . Others recommended venous thromboembolism prophylaxis needs to be considered on a case-by-case basis (44, 58). We identified four recommendations from four guidelines regarding prone ventilation in pregnant women. Two indicated that while prone ventilation is strongly recommended in adults with severe Acute Respiratory Distress Syndrome, there is little evidence on prone position in pregnant women, and in this case the lateral decubitus position may be more beneficial (62, 73) . One suggested that prone positioning may not be feasible in pregnancy but should be considered in early (pre-viable) gestations (58), however another stated prone positioning was indeed feasible in pregnancy and could be used in addition to the lateral decubitus position (44). There was limited guidance regarding the use of intubation in pregnant women (five recommendations from three guidelines). It was suggested that the timing of intubation should be individualised (44), with another guideline recommending early intubation for pregnant women whose respiratory function deteriorates (65). Another guideline stated pregnant women were at risk of aspiration requiring early intubation (58) . One guideline suggested that in pregnant women, mechanical ventilation may not be sufficient for severe respiratory failure and extracorporeal membrane oxygenation may have a role (65). Two other recommendations also referred to the use of extracorporeal membrane oxygenation -One guideline from the USA advised its use be discussed if expedited birth was being considered for severe hypoxaemia (44), and another from China (Chen et al.) recommended its use be limited during pregnancy with less invasive measures used beforehand (81) . We identified a large and growing volume of maternal and perinatal health guidelines related to COVID-19 over a six-week period. We identified limited consensus amongst guideline development organisations regarding key maternal and newborn health interventions, including nitrous oxide during labour, policies on birth companions, rooming-in, antenatal corticosteroids, anticoagulants and the use of antivirals and other disease modifying agents. Available guidelines were produced rapidly in the context of the COVID-19 pandemic, generally in the absence of direct evidence. Given the frequency of updates, it is difficult for clinicians and services to stay up-to-date with the most recent guidance. Our review has included a large number of guidelines from a range of different organisations worldwide. Through weekly checks, we closely monitored updates to pre-existing recommendations and guidelines and were able to identify key areas of disagreement. A limitation to this review is the pace at which guidance is being updated, given the emergence of new information and evidence regarding COVID-19 and its impacts on women and newborns. Many guidelines were regularly updated, and in several instances, recommendations were significantly changed or removed entirely. This makes it difficult for clinicians and health services to stay up-to-date with best practice. Additionally, we were limited in our ability to translate guidelines and there were few guidelines reviewed in languages other than English. Two recent publications by Cochrane Pregnancy and Childbirth (90) and Narang et al. (91) considered a range of maternal and perinatal health guidelines related to the COVID-19 pandemic. The Cochrane report, which focused on guidelines in a subset of countries with more than 10,000 cases of COVID-19 on 19th April, similarly found a lack of consensus in the use of antenatal steroids, the use of nitrous oxide, policies on birth companions and rooming-in, as well as skin-to-skin contact and breastfeeding -two interventions for which our review found more general consensus. Narang Maternal and newborn health guidance has been rapidly produced in response to the COVID-19 pandemic. Our review identified 81 unique guidelines from 48 different organisations related to the antenatal, intrapartum and postpartum care of women during the pandemic. We found lower consensus between guidelines regarding nitrous oxide during labour, policies on birth companions, rooming-in, antenatal corticosteroids, anticoagulants and the use of antivirals and other disease modifying agents. Due to the large number of guidelines being produced as well as these areas of disagreement, it can be difficult for clinicians to determine how best to care for pregnant and postpartum women in the context of COVID-19. This review provides a summary of available recommendations to help guide clinicians and health services, as well as other maternal and perinatal health guideline developers. Given the rapidly evolving nature of the situation and the J o u r n a l P r e -p r o o f changes that have already occurred since our review in May 2020, it is vital that health workers seek out the latest guidance when making clinical decisions. Author contributions CH, JV and AW conceptualised the study. JV, KE, AW and CH wrote the study protocol. 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Royal College of Physicians of Ireland (RCPI) COVID-19 review of national clinical practice guidelines for key questions relating to the care of pregnant women and their babies SARS-CoV-2 in Pregnancy: A Comprehensive Summary of Current Guidelines Living Systematic Review N. Living systematic reviews: 4. Living guideline recommendations Developing and applying a 'living guidelines' approach to WHO recommendations on maternal and perinatal health Bringing stroke clinical guidelines to life BOXES Box 1: Priority topics Provision of maternal health care during the COVID-19 pandemic Not applicable.J o u r n a l P r e -p r o o f