Cohort profile: the BABY1000 pilot prospective longitudinal birth cohort study based in Sydney, Australia.

PURPOSE: The health of parents prior to conception, a woman's health during pregnancy and the infant's environment across their first months and years collectively have profound effects on the child's health across the lifespan. Since there are very few cohort studies in early pregnancy, gaps remain in our understanding of the mechanisms underpinning these relationships, and how health may be optimised. 'BABY1000', a pilot prospective longitudinal birth cohort study, aims to (1) identify factors before and during pregnancy and early life that impact longer-term health and (2) assess the feasibility and acceptability of study design to inform future research. PARTICIPANTS: Participants were based in Sydney, Australia. Women were recruited at preconception or 12 weeks' gestation, and data were collected from them throughout pregnancy and postpartum, their children until the age of 2 years, and dietary information from a partner (if able) at the last study visit. The pilot aimed to recruit 250 women. However, recruitment ceased earlier than planned secondary to limitations from the COVID-19 pandemic and the final number of subjects was 225. FINDINGS TO DATE: Biosamples, clinical measurements and sociodemographic/psychosocial measures were collected using validated tools and questionnaires. Data analysis and 24-month follow-up assessments for children are ongoing. Key early findings presented include participant demographics and dietary adequacy during pregnancy. The COVID-19 pandemic and associated public health and research restrictions affected recruitment of participants, follow-up assessments and data completeness. FUTURE PLANS: The BABY1000 study will provide further insight into the developmental origins of health and disease and inform design and implementation of future cohort and intervention studies in the field. Since the BABY1000 pilot was conducted across the COVID-19 pandemic, it also provides unique insight into the early impacts of the pandemic on families, which may have effects on health across the lifespan.

Prevalence and impact of SARS-CoV-2 infection on maternal and infant health in African populations: protocol of a multicentre prospective cohort study (MA-CoV project).

INTRODUCTION: Pregnant women are currently considered a vulnerable population to SARS-CoV-2 infection, with increased risk of severe COVID-19, preterm birth and maternal mortality. There is, however, a paucity of data on the burden of maternal SARS-CoV-2 infection in sub-Saharan countries. The objective of this study is to determine the prevalence and health effects of maternal SARS-CoV-2 infection in selected sites from Gabon and Mozambique. METHODS AND ANALYSIS: MA-CoV (MAternal CoVid) is an observational, multicentre prospective cohort study where 1000 pregnant women (500 per country) will be enrolled at the antenatal clinic visits. Participants will undergo monthly follow-up at each antenatal care visit, delivery and postpartum visit. The primary study outcome is the prevalence of SARS-CoV-2 infection during pregnancy. The clinical presentation of COVID-19 in pregnancy will also be characterised, and incidence of infection during pregnancy will be evaluated, as well as the risk factors of maternal and neonatal morbidity and mortality associated with SARS-CoV-2 infection and the risk of mother to child transmission of SARS-CoV-2. SARS-CoV-2 infection screening will be performed through PCR diagnosis. ETHICS AND DISSEMINATION: The protocol was reviewed and approved by the Comité National d'Éthique pour la Recherche au Gabon, Comité Nacional de Bioética para Saúde de Moçambique and the Ethics Committee of the Hospital Clinic of Barcelona (Spain). Project results will be presented to all stakeholders and published in open access journals. TRIAL REGISTRATION NUMBER: NCT05303168.

Pregnancy exposure registries for drugs and vaccines in low-income and middle-income countries: scoping review protocol.

INTRODUCTION: Data regarding the safety of drugs and vaccines in pregnant women are typically unavailable before licensure. Pregnancy exposure registries (PERs) are an important source of postmarketing safety information. PERs in low-income and middle-income countries (LMICs) are uncommon but can provide valuable safety data regarding their distinct contexts and will become more relevant as the introduction and use of new drugs and vaccines in pregnancy increase worldwide. Strategies to support PERs in LMICs must be based on a better understanding of their current status. We developed a scoping review protocol to assess the landscape of PERs that operate in LMICs and characterise their strengths and challenges. METHODS AND ANALYSIS: This scoping review protocol follows the Joanna Briggs Institute manual for scoping reviews. The search strategy will be reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews Checklist. We will search PubMed, Embase, CINAHL and WHO's Global Index Medicus, as well as the reference lists of retrieved full-text records, for articles published between 2000 and 2022 that describe PERs or other resources that systematically record exposures to medical products during pregnancy and maternal and infant outcomes in LMICs. Title and abstracts will be screened by two authors and data extracted using a standardised form. We will undertake a grey literature search using Google Scholar and targeted websites. We will distribute an online survey to selected experts and conduct semistructured interviews with key informants. Identified PERs will be summarised in tables and analysed. ETHICS AND DISSEMINATION: Ethical approval is not required for this activity, as it was determined not to involve human subjects research. Findings will be submitted to an open access peer-reviewed journal and may be presented at conferences, with underlying data and other materials made publicly available.

Vaccine intention and hesitancy among Australian women who are currently pregnant or have recently given birth: the Birth in the Time of COVID-19 (BITTOC) national online survey.

OBJECTIVE: To examine the prevalence of COVID-19 vaccination, and factors associated with vaccination intention and hesitancy in pregnant and postnatal women in Australia. DESIGN AND SETTING: A national online survey was conducted over 6 months between 31 August 2021 and 1 March 2022 and responses to vaccination status were categorised as: 'vaccinated', 'vaccine intended' and 'vaccine hesitant'. The data were weighted to reflect the proportion of women of reproductive age. Potential confounding variables were examined using multinomial logistic regression analyses, and all comparisons were made against vaccinated pregnant and postnatal women. PARTICIPANTS: 2140 women responded to the survey (838 pregnant; 1302 recently post partum). RESULTS: Amongst pregnant women, 586 (69.9%) were vaccinated, 166 (19.8%) indicated intention and 86 (10.3%) were hesitant. In postnatal women, this was 1060 (81.4%), 143 (11.0%) and 99 (7.6%), respectively. Only 52 (6.2%) of pregnant women stated never wanting a COVID-19 vaccine. Vaccine hesitancy increased over time, and for pregnant women was associated with: living in a state other than New South Wales (NSW) (Adjusted Relative Risk (ARR) 2.77, 95%CI: 1.68-4.56 for vaccine intention and ARR=3.31, 95%CI: 1.52-7.20 for vaccine hesitancy), younger age <30 years, not having a university education, income <80K AUD, gestation <28 weeks, having no pregnancy risk factors, and being less satisfied with life (ARR=2.20, 95%CI: 1.04-4.65 for vaccine intention and ARR=2.53, 95%CI: 1.02-6.25 for vaccine hesitancy) . For postnatal women: living in a state other than NSW or Victoria, income <80K AUD and having private obstetric care (ARR=2.06, 95%CI: 1.23-3.46) were significantly associated with vaccine hesitancy. CONCLUSIONS: Around 1 in 10 pregnant women and just over 1 in 13 postnatal women reported vaccine hesitancy in this Australian survey, and hesitancy was higher in the latter 3-month period. Tailored messages to younger mothers and those from lower-middle socioeconomic groups, alongside advice from midwives and obstetricians, could help to reduce hesitancy among pregnant and postnatal women. Financial incentives may help to facilitate COVID-19 vaccine uptake. A real-time surveillance system and additional pregnancy fields added to the Australian immunisation register would support the safety monitoring of multiple vaccines in pregnancy and may build confidence.

Decision Analysis in SHared decision making for Thromboprophylaxis during Pregnancy (DASH-TOP): a sequential explanatory mixed-methods pilot study.

OBJECTIVES: To gain insight into formal methods of integrating patient preferences and clinical evidence to inform treatment decisions, we explored patients' experience with a personalised decision analysis intervention, for prophylactic low-molecular-weight heparin (LMWH) in the antenatal period. DESIGN: Mixed-methods explanatory sequential pilot study. SETTING: Hospitals in Canada (n=1) and Spain (n=4 sites). Due to the COVID-19 pandemic, we conducted part of the study virtually. PARTICIPANTS: 15 individuals with a prior venous thromboembolism who were pregnant or planning pregnancy and had been referred for counselling regarding LMWH. INTERVENTION: A shared decision-making intervention that included three components: (1) direct choice exercise; (2) preference elicitation exercises and (3) personalised decision analysis. MAIN OUTCOME MEASURES: Participants completed a self-administered questionnaire to evaluate decision quality (decisional conflict, self-efficacy and satisfaction). Semistructured interviews were then conducted to explore their experience and perceptions of the decision-making process. RESULTS: Participants in the study appreciated the opportunity to use an evidence-based decision support tool that considered their personal values and preferences and reported feeling more prepared for their consultation. However, there were mixed reactions to the standard gamble and personalised treatment recommendation. Some participants could not understand how to complete the standard gamble exercises, and others highlighted the need for more informative ways of presenting results of the decision analysis. CONCLUSION: Our results highlight the challenges and opportunities for those who wish to incorporate decision analysis to support shared decision-making for clinical decisions.

Improving family functioning and reducing violence in the home in North Kivu, Democratic Republic of Congo: a pilot cluster-randomised controlled trial of Safe at Home.

OBJECTIVE: To test the effectiveness of the Safe at Home programme which was developed to improve family well-being and prevent multiple forms of violence in the home. DESIGN: Waitlisted pilot cluster randomised controlled trial. SETTING: North Kivu, Democratic Republic of Congo. PARTICIPANTS: 202 heterosexual couples. INTERVENTION: The Safe at Home programme. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was family functioning, with secondary outcomes of past-3 month co-occurring violence, intimate partner violence (IPV) and harsh discipline. Pathway mechanisms assessed included attitudes related to acceptance of harsh discipline, gender equitable attitudes, positive parenting skills and power sharing within the couple. RESULTS: No significant improvements in family functioning were documented for women (ß=1.49; 95% CI: -2.75 to 5.74; p=0.49) and men (ß=1.09; 95% CI: -3.13 to 4.74; p=0.69). However, women in Safe at Home reported a OR=0.15 (p=0.000), OR=0.23 (p=0.001) and OR=0.29 (p=0.013) change in co-occurring IPV and harsh discipline; physical/sexual/emotional IPV by their partner and use of physical and/or emotional harsh discipline against their child, respectively, as compared with women in the waitlisted group. Men participating in Safe at Home reported a OR=0.23 (p=0.005) change in perpetration of co-occurring violence, OR=0.26 (p=0.003) change in any form of IPV perpetration and OR=0.56 (p=0.19) change in use of harsh discipline against their child as compared with the waitlist arm. Positive changes were also noted in pathway variables around attitudes, skills and behaviours within couples. CONCLUSION: This pilot trial demonstrated the Safe at Home programme to be highly effective in preventing multiple forms of violence in the home and improving equitable attitudes and skills in couples. Future research should assess longitudinal impact and implementation at scale. TRIAL REGISTRATION NUMBER: NCT04163549.

Neuromotor repertoires in infants exposed to maternal COVID-19 during pregnancy: a cohort study.

OBJECTIVE: To evaluate neuromotor repertoires and developmental milestones in infants exposed to antenatal COVID-19. DESIGN: Longitudinal cohort study. SETTING: Hospital-based study in Los Angeles, USA and Rio de Janeiro, Brazil between March 2020 and December 2021. PARTICIPANTS: Infants born to mothers with COVID-19 during pregnancy and prepandemic control infants from the Graz University Database. INTERVENTIONS: General movement assessment (GMA) videos between 3 and 5 months post-term age were collected and clinical assessments/developmental milestones evaluated at 6-8 months of age. Cases were matched by gestational age, gender and post-term age to prepandemic neurotypical unexposed controls from the database. MAIN OUTCOME MEASURES: Motor Optimality Scores Revised (MOS-R) at 3-5 months. Presence of developmental delay (DD) at 6-8 months. RESULTS: 239 infants were enrolled; 124 cases (83 in the USA/41 in Brazil) and 115 controls. GMA was assessed in 115 cases and 115 controls; 25% were preterm. Median MOS-R in cases was 23 (IQR 21-24, range 9-28) vs 25 (IQR 24-26, range 20-28) in controls, p<0.001. Sixteen infants (14%) had MOS-R scores <20 vs zero controls, p<0.001. At 6-8 months, 13 of 109 case infants (12%) failed to attain developmental milestones; all 115 control infants had normal development. The timing of maternal infection in pregnancy (first, second or third trimester) or COVID-19 disease severity (NIH categories asymptomatic, mild/moderate or severe/critical) was not associated with suboptimal MOS-R or DD. Maternal fever in pregnancy was associated with DD (OR 3.7; 95% CI 1.12 to 12.60) but not suboptimal MOS-R (OR 0.25; 95% CI 0.04 to 0.96). CONCLUSIONS: Compared with prepandemic controls, infants exposed to antenatal COVID-19 more frequently had suboptimal neuromotor development.

Risk factors for severe disease and impact of severity on pregnant women with COVID-19: a case-control study based on data from a nationwide survey of maternity services in Japan.

OBJECTIVE: To identify independent risk factors for severe COVID-19 in pregnant women and to evaluate the impact of disease severity on preterm birth. DESIGN: A case-control study based on data from a nationwide questionnaire-based survey of maternity services in Japan. SETTING: A questionnaire was mailed to all 2135 delivery institutions in Japan between July and August 2021. A total of 1288 institutions responded (60% of all delivery institutions in Japan). 566 facilities reported having cared for pregnant women with COVID-19, and 722 facilities reported having had no such patients. PARTICIPANTS: One thousand and forty-three hospitalised and non-hospitalised pregnant women diagnosed with COVID-19 between July 2020 and 30 June 2021. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was progression to severe COVID-19. The secondary outcome was preterm birth due to COVID-19 infection. RESULTS: 56 cases (5.4%) were severe, and 987 (94.6%) were non-severe. Multivariable logistic regression analysis showed that gestational age≥24 weeks (adjusted OR (aOR) 6.68, 95% CI 2.8 to 16.0) and maternal age≥32 years (aOR 2.40, 95% CI 1.3 to 4.3) were independently associated with severe cases. Using the Kaplan-Meier method, the probability of continued pregnancy at 14 days after diagnosis for severe cases was 0.57 between 24 and 31 weeks' gestation and 0.27 between 32 and 36 weeks' gestation. The probability for non-severe cases was 1.0 between 24 and 31 weeks' gestation and 0.8 between 32 and 36 weeks' gestation. Among the patients with COVID-19 in the preterm period, preterm birth due to infection was significantly more common in severe than non-severe cases (48% vs 6%, p< 0.0001). CONCLUSIONS: Severe COVID-19 in pregnant women was associated with gestational age≥24 weeks and maternal age≥32. The rate of preterm delivery due to the infection was significantly higher in severe COVID-19 cases.

Effect of the COVID-19 pandemic on maternal healthcare indices in Southern Iran: an interrupted time series analysis.

OBJECTIVES: Epidemics are anticipated to influence the coverage of health services. We assessed the impact of the COVID-19 pandemic on maternal healthcare indices and care providers' performance. SETTING: 1801 maternal healthcare centres under the auspices of Shiraz University of Medical Sciences, Shiraz, Southern Iran. PARTICIPANTS: Approximately 63 000 pregnant women. PRIMARY AND SECONDARY OUTCOME MEASURES: In this prospective ecological study, interrupted time series analysis was used to model and compare the trend of maternal healthcare indices before and after the COVID-19 pandemic announcement. RESULTS: The results showed a significant drop in count of preconception healthcare visits, first routine laboratory tests, first trimester prenatal care, first trimester sonography, prenatal screening for birth defects at weeks 11-13, prenatal care visits at weeks 16-20, second routine laboratory tests, second trimester sonography, prenatal care visits at weeks 24-30, prenatal care visits at weeks 31-34, postpartum care visits at days 10-15 and postpartum care visits at days 30-42 with the start of the COVID-19 pandemic (-50% (95% CI -48.68% to -51.36%), -19.67% (95% CI -22.12% to -17.15%), -25.88% (95% CI -28.46% to -23.21%), -23.84% (95% CI -26.26% to -21.34%), -20.16% (95% CI -23.01% to -17.20%), -18.53% (95% CI -21.25% to -15.71%), -28.63% (95% CI -31.03% to -26.14%), -27.48% (95% CI -30.07% to -24.79%), -31.08% (95% CI -33.43% to -28.61%), -31.84% (95% CI -34.35% to -29.23%), 32.55% (95% CI -35.12% to -29.89%) and -39.28% (95% CI -41.59% to -36.88%), respectively). Nevertheless, the trend in coverage of these services showed recovery in the subsequent months (8.36%, 10.55%, 5.74%, 8.01%, 4.40%, 5.06%, 11.20%, 7.58%, 7.38%, 7.80%, 9.59% and 9.61% per month, respectively). CONCLUSIONS: Using ecological data during the COVID-19 pandemic era, we observed a 'level change and slope change' as the major pattern of interruption of maternal healthcare coverage, indicating a possible indirect effect rather than a causative relationship. Such relative predictability might assist with future pandemic planning.

Realist inquiry into Maternity care @ a Distance (ARM@DA): realist review protocol.

INTRODUCTION: One of the most commonly reported COVID-19-related changes to all maternity services has been an increase in the use of digital clinical consultations such as telephone or video calling; however, the ways in which they can be optimally used along maternity care pathways remain unclear. It is imperative that digital service innovations do not further exacerbate (and, ideally, should tackle) existing inequalities in service access and clinical outcomes. Using a realist approach, this project aims to synthesise the evidence around implementation of digital clinical consultations, seeking to illuminate how they can work to support safe, personalised and appropriate maternity care and to clarify when they might be most appropriately used, for whom, when, and in what contexts? METHODS AND ANALYSIS: The review will be conducted in four iterative phases, with embedded stakeholder involvement: (1) refining the review focus and generating initial programme theories, (2) exploring and developing the programme theories in light of evidence, (3) testing/refining the programme theories and (4) constructing actionable recommendations. The review will draw on four sources of evidence: (1) published literature (searching nine bibliographic databases), (2) unpublished (grey) literature, including research, audit, evaluation and policy documents (derived from Google Scholar, website searches and e-thesis databases), (3) expertise contributed by service user and health professional stakeholder groups (n=20-35) and (4) key informant interviews (n=12). Included papers will consist of any study design, in English and from 2010 onwards. The review will follow the Realist and Meta-narrative Evidence Synthesis Evolving Standards quality procedures and reporting guidance. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the University of Nottingham, Faculty of Medicine and Health Sciences Ethics Committee (FMHS 426-1221). Informed consent will be obtained for all key informant interviews. Findings will be disseminated in a range of formats relevant to different audiences. PROSPERO REGISTRATION NUMBER: CRD42021288702.

Safer Baby Bundle: study protocol for the economic evaluation of a quality improvement initiative to reduce stillbirths.

INTRODUCTION: Stillbirth continues to be a public health concern in high-income countries, and with mixed results from several stillbirth prevention interventions worldwide the need for an effective prevention method is ever present. The Safer Baby Bundle (SBB) proposes five evidence-based care packages shown to reduce stillbirth when implemented individually, and therefore are anticipated to produce significantly better outcomes if grouped together. This protocol describes the planned economic evaluation of the SBB quality improvement initiative in Australia. METHODS AND ANALYSIS: The implementation of the SBB will occur over three state-based health jurisdictions in Australia-New South Wales, Queensland and Victoria, from July 2019 onwards. The intervention is being applied at the state level, with sites opting to participate or not, and no individual woman recruitment. The economic evaluation will be based on a whole-of-population linked administrative dataset, which will include the data of all mothers, and their resultant children, who gave birth between 1 January 2016 and 31 December 2023 in these states, covering the preimplementation and postimplementation time period. The primary health outcome for this economic evaluation is late gestation stillbirths, with the secondary outcomes including but not limited to neonatal death, gestation at birth, mode of birth, admission to special care nursery and neonatal intensive care unit, and physical and mental health conditions for mother and child. Costs associated with all healthcare use from birth to 5 years post partum will be included for all women and children. A cost-effectiveness analysis will be undertaken using a difference-in-difference analysis approach to compare the primary outcome (late gestation stillbirth) and total costs for women before and after the implementation of the bundle. ETHICS AND DISSEMINATION: Ethics approval for the SBB project was provided by the Royal Brisbane & Women's Hospital Human Research Ethics Committee (approval number: HREC/2019/QRBW/47709). Approval for the extraction of data to be used for the economic evaluation was granted by the New South Wales Population and Health Services Research Ethics Committee (approval number: 2020/ETH00684/2020.11), Australian Institute of Health and Welfare Human Research Ethics Committee (approval number: EO2020/4/1167), and Public Health Approval (approval number: PHA 20.00684) was also granted. Dissemination will occur via publication in peer reviewed journals, presentation at clinical and policy-focused conferences and meetings, and through the authors' clinical and policy networks.This study will provide evidence around the cost effectiveness of a quality improvement initiative to prevent stillbirth, identifying the impact on health service use during pregnancy and long-term health service use of children.

Changes in perinatal mental healthcare during the COVID-19 pandemic: a protocol for a collaborative research study between the COST actions RISEUP-PPD and DEVOTION.

INTRODUCTION: Significant changes in routine maternity care have been introduced globally in response to the COVID-19 pandemic to reduce infection risk, but also due to lack of medical facilities, staff shortages and the unpredictable nature of the disease. However, it is yet to be established if specialised perinatal mental health (PMH) services have been similarly affected. As a Task Force in PMH and COVID-19 pandemic within Riseup-PPD COST Action, this study aims to identify changes in PMH practices, policies and protocols during the COVID-19 pandemic in Europe. METHODS AND ANALYSIS: An online survey of experts in the PMH who are members of the COST Action 'Riseup-PPD' and the COST Action ''DEVOTION" across 36 European countries will be conducted. A questionnaire on changes in PMH care practices during the COVID-19 Pandemic will be administered. It consists of open-ended questions, checklists and ratings on a 7-point scale addressing seven domains of interest in terms of PMH: (1) policies, guidelines and protocols; (2) PMH care practices at a national level; (3) evidence of best practice; (4) barriers to usual care; (5) resources invested; (6) benefits of investment in the policies and (7) short-term and long-term expectations of the policies. Data will be collected using Qualtrics. Descriptive statistics will be reported and differences between countries will be examined using the χ2 statistic or Student's t-test. ETHICS AND DISSEMINATION: Ethical approval was obtained from The Ethics Committee for Research in Life and Health Sciences of the University of Minho (Portugal) to undertake an anonymous online survey. The findings will be disseminated to professional audience through peer-review publication and presentations and shared widely with stakeholders, policy-makers and service user groups. A position paper will be developed to influence policy-making at a European level to alleviate the adversities caused by COVID-19. TRIAL REGISTRATION NUMBER: NCT04779775.

Investigating service delivery and perinatal outcomes during the low prevalence first year of COVID-19 in a multiethnic Australian population: a cohort study.

OBJECTIVE: Investigate the impact of the COVID-19 pandemic on perinatal outcomes in an Australian high migrant and low COVID-19 prevalent population to identify if COVID-19 driven health service changes and societal influences impact obstetric and perinatal outcomes. DESIGN: Retrospective cohort study with pre COVID-19 period 1 January 2018-31 January 2020, and first year of global COVID-19 period 1 February 2020-31 January 2021. Multivariate logistic regression analysis was conducted adjusting for confounders including age, area-level socioeconomic status, gestation, parity, ethnicity and body mass index. SETTING: Obstetric population attending three public hospitals including a major tertiary referral centre in Western Sydney, Australia. PARTICIPANTS: Women who delivered with singleton pregnancies over 20 weeks gestation. Ethnically diverse women, 66% overseas born. There were 34 103 births in the district that met inclusion criteria: before COVID-19 n=23 722, during COVID-19 n=10 381. MAIN OUTCOME MEASURES: Induction of labour, caesarean section delivery, iatrogenic and spontaneous preterm birth, small for gestational age (SGA), composite neonatal adverse outcome and full breastfeeding at hospital discharge. RESULTS: During the first year of COVID-19, there was no change for induction of labour (adjusted OR, aOR 0.97; 95% CI 0.92 to 1.02, p=0.26) and a 25% increase in caesarean section births (aOR 1.25; 95% CI 1.19 to 1.32, p<0.001). During the COVID-19 period, we found no change in iatrogenic preterm births (aOR 0.94; 95% CI 0.80 to 1.09) but a 15% reduction in spontaneous preterm birth (aOR 0.85; 95% CI 0.75 to 0.97, p=0.02) and a 10% reduction in SGA infants at birth (aOR 0.90; 95% CI 0.82 to 0.99, p=0.02). Composite adverse neonatal outcomes were marginally higher (aOR 1.08; 95% CI 1.00 to 1.15, p=0.04) and full breastfeeding rates at hospital discharge reduced by 15% (aOR 0.85; 95% CI 0.80 to 0.90, p<0.001). CONCLUSION: Despite a low prevalence of COVID-19, both positive and adverse obstetric outcomes were observed that may be related to changes in service delivery and interaction with healthcare providers. Further research is suggested to understand the drivers for these changes.

Adherence to face mask use during the COVID-19 pandemic among women seeking antenatal care in Kinshasa, Democratic Republic of Congo: a facility-based cross-sectional study.

OBJECTIVES: To describe face mask use among pregnant women seeking antenatal care (ANC) in Kinshasa, Democratic Republic of Congo and to identify factors associated with masking adherence in this population. DESIGN: Facility-based cross-sectional study nested within a prospective cohort study. SETTING: Random sample of 10 health facilities, including 5 primary health centers and 5 secondary facilities or hospitals. PARTICIPANTS: A total of 934 pregnant women aged 18 years or above with a gestational age of at least 32 weeks were consecutively surveyed from 17 August 2020 to 31 January 2021. PRIMARY AND SECONDARY OUTCOME MEASURES: We estimated the proportions of pregnant women wearing a face mask and masking correctly (ie, over the mouth and nose), and assessed their knowledge regarding the COVID-19 pandemic. Multivariable logistic regression was employed to identify factors associated with overall and correct face mask use. RESULTS: Overall, 309 (33.1%) women wore a mask during the interview after their antenatal appointments, but only 33 (10.7%) wore a mask correctly. The odds of masking and correct mask use were significantly higher among women who had their ANC visit in a facility that provided COVID-19 care. Additionally, women who experienced COVID-19-like symptoms in the past 6 months had higher odds of wearing a mask correctly compared with those reporting no recent symptoms. Although 908 (97.2%) women were aware of the COVID-19 pandemic, only 611 (67.3%) thought that COVID-19 was circulating locally in Kinshasa. CONCLUSION: Overall and correct face mask adherence levels were low among pregnant women attending ANC in Kinshasa. Our study highlights the need for improving adherence to correct face mask use in order to help control the spread of COVID-19 within Kinshasa alongside other control measures, like vaccination.

Cohort profile: the Western Cape Pregnancy Exposure Registry (WCPER).

PURPOSE: The Western Cape Pregnancy Exposure Registry (PER) was established at two public sector healthcare sentinel sites in the Western Cape province, South Africa, to provide ongoing surveillance of drug exposures in pregnancy and associations with pregnancy outcomes. PARTICIPANTS: Established in 2016, all women attending their first antenatal visit at primary care obstetric facilities were enrolled and followed to pregnancy outcome regardless of the site (ie, primary, secondary, tertiary facility). Routine operational obstetric and medical data are digitised from the clinical stationery at the healthcare facilities. Data collection has been integrated into existing services and information platforms and supports routine operations. The PER is situated within the Provincial Health Data Centre, an information exchange that harmonises and consolidates all health-related electronic data in the province. Data are contributed via linkage across a unique identifier. This relationship limits the missing data in the PER, allows validation and avoids misclassification in the population-level data set. FINDINGS TO DATE: Approximately 5000 and 3500 pregnant women enter the data set annually at the urban and rural sites, respectively. As of August 2021, >30 000 pregnancies have been recorded and outcomes have been determined for 93%. Analysis of key obstetric and neonatal health indicators derived from the PER are consistent with the aggregate data in the District Health Information System. FUTURE PLANS: This represents significant infrastructure, able to address clinical and epidemiological concerns in a low/middle-income setting.

Multilevel determinants of racial/ethnic disparities in severe maternal morbidity and mortality in the context of the COVID-19 pandemic in the USA: protocol for a concurrent triangulation, mixed-methods study.

INTRODUCTION: The COVID-19 pandemic has affected communities of colour the hardest. Non-Hispanic black and Hispanic pregnant women appear to have disproportionate SARS-CoV-2 infection and death rates. METHODS AND ANALYSIS: We will use the socioecological framework and employ a concurrent triangulation, mixed-methods study design to achieve three specific aims: (1) examine the impacts of the COVID-19 pandemic on racial/ethnic disparities in severe maternal morbidity and mortality (SMMM); (2) explore how social contexts (eg, racial/ethnic residential segregation) have contributed to the widening of racial/ethnic disparities in SMMM during the pandemic and identify distinct mediating pathways through maternity care and mental health; and (3) determine the role of social contextual factors on racial/ethnic disparities in pregnancy-related morbidities using machine learning algorithms. We will leverage an existing South Carolina COVID-19 Cohort by creating a pregnancy cohort that links COVID-19 testing data, electronic health records (EHRs), vital records data, healthcare utilisation data and billing data for all births in South Carolina (SC) between 2018 and 2021 (>200 000 births). We will also conduct similar analyses using EHR data from the National COVID-19 Cohort Collaborative including >270 000 women who had a childbirth between 2018 and 2021 in the USA. We will use a convergent parallel design which includes a quantitative analysis of data from the 2018-2021 SC Pregnancy Risk Assessment and Monitoring System (unweighted n>2000) and in-depth interviews of 40 postpartum women and 10 maternal care providers to identify distinct mediating pathways. ETHICS AND DISSEMINATION: The study was approved by institutional review boards at the University of SC (Pro00115169) and the SC Department of Health and Environmental Control (DHEC IRB.21-030). Informed consent will be provided by the participants in the in-depth interviews. Study findings will be disseminated with key stakeholders including patients, presented at academic conferences and published in peer-reviewed journals.

Heated tobacco product use and hypertensive disorders of pregnancy and low birth weight: analysis of a cross-sectional, web-based survey in Japan

ObjectivesKnowledge on the impact of heated tobacco product (HTP) use in pregnant women with associated maternal and neonatal risks for hypertensive disorders of pregnancy (HDP) and low birth weight (LBW) is limited. We aimed to assess the status of HTP use among pregnant women in Japan and explore the association of HTP use with HDP and LBW.DesignCross-sectional study.SettingData from the Japan ‘COVID-19 and Society’ Internet Survey study, a web-based nationwide survey.ParticipantsWe investigated 558 postdelivery and 365 currently pregnant women in October 2020.Primary and secondary outcome measuresInformation on HDP and LBW was collected from the postdelivery women’s Maternal and Child Health Handbooks (maternal and newborn records). We estimated the age-adjusted ORs and 95% CIs of ever HTP smokers for HDP and LBW and compared them with those of never HTP smokers in a logistic regression analysis.ResultsThe prevalence of ever and current HTP use were 11.7% and 2.7% in postdelivery women and 12.6% and 1.1% in currently pregnant women, respectively. Among currently pregnant women who were former combustible cigarette smokers, 4.4% (4/91) were current HTP smokers. Among postdelivery women, ever HTP smokers had a higher HDP incidence (13.8% vs 6.5%, p=0.03;age-adjusted OR=2.48, 95% CI 1.11 to 5.53) and higher LBW incidence (18.5% vs 8.9%, p=0.02;age-adjusted OR=2.36, 95% CI 1.16 to 4.87).ConclusionsIn Japan, the incidence of ever HTP use exceeded 10% among pregnant women, and HTP smoking may be associated with maternal and neonatal risks.

International survey on fear and childbirth experience in pregnancy and the postpartum period during the COVID-19 pandemic: study protocol

IntroductionThe COVID-19 pandemic has caused unprecedented disruptions around the world. Adding to the existing stress surrounding pregnancy and childbirth, the threat of infection and social isolation policies may negatively impact pregnant women and new mothers. Literature on the effect of COVID-19 on fear during pregnancy and childbirth experience is limited. As the COVID-19 pandemic continues to affect the global population, it is important to understand how it has impacted pregnant women and new mothers’ experiences worldwide to inform perinatal care and interventions.Methods and analysisThis multicountry study involving China and Canada targets to recruit 1000 pregnant women and new mothers who gave birth since 2020 in each participating country. Participants will be recruited online in the local language through mothers’ groups, antenatal and postnatal clinics and hospital wards. All questionnaires will be completed online. Participants’ level of fear, depression and childbirth experience will be assessed along with other sociodemographic, medical and COVID-related measures. Regression models will be used to compare the outcomes among the participating countries.Ethics and disseminationThe study has been reviewed and approved by the institutional review boards of the participating countries. Findings will be disseminated in peer-reviewed journals and academic conferences. Results from this study may guide the formulation of future health guidelines and policies in the face of a pandemic.

Effect of restrictions imposed due to COVID-19 pandemic on the antenatal care and pregnancy outcomes: a prospective observational study from rural North India.

OBJECTIVES: To assess the difficulties faced by the pregnant women in seeking appropriate antenatal care due to the restrictions imposed during the COVID-19 pandemic; assess the difficulties encountered during delivery and postpartum period; the suitability of the teleconsultation services offered; effect of COVID-19 infection on pregnancy outcomes and the effect of restrictions on the nutrition profile of the pregnant women. DESIGN: Prospective observational study. SETTING AND PARTICIPANTS: We included 1374 pregnant women from the rural areas of three districts of Punjab, India registered at government health centres before the implementation of lockdown due to the COVID-19 pandemic on 24 March 2020. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the difficulties faced by the women during their pregnancies due to restrictions imposed during the lockdown. The secondary outcomes included the effect of COVID-19 infections on pregnancy outcomes, satisfaction from the telemedicine services and restrictions on the nutrition profile of the pregnant women. RESULTS: One-third of the women (38.4%) considered their last pregnancy unplanned. Women faced difficulties due to the restrictions in getting adequate nutrition (76.5%), accessing transportation facilities (35.4%), consultations from doctors (22.4%) or getting an ultrasonography scan (48.7%). One-fifth (21.9%) of women could not access safe abortion services. Only 3.6% of respondents ever took any teleconsultation services offered by the government. Most of them felt unsatisfied compared with routine visits (77.5%). COVID-19-infected women were primarily asymptomatic (76.1%), but there was a high incidence of preterm birth (42.8%). Frontline workers could visit 64.3% of the women in the postpartum period despite restrictions. CONCLUSIONS: Lockdown compromised the antenatal care in our study area while the frontline workers attempted to minimise the inconvenience. Telemedicine services did not prove to be of many benefits to pregnant women and should only work as a supplement to the existing protocols of antenatal care.