Cohort profile: Rahima Moosa Mother and Child Hospital maternal HIV cohort, Johannesburg, South Africa.

PURPOSE: The Rahima Moosa Mother and Child Hospital (RMMCH) maternal HIV cohort originated from data systems that were developed to support HIV-related birth care and track outcomes of a complete birth cohort of HIV-exposed infants at Rahima Moosa Hospital and their mothers living with HIV. PARTICIPANTS: Supported by the Empilweni Services and Research Unit, maternal and infant data from 13 654 pregnant women living with HIV who delivered their infants (and a subset also attended antenatal care) were collected at RMMCH in Johannesburg, South Africa since 2013. Maternal data were collected using counsellor-administered interviews and the 2013-2018 subset of this cohort was linked to the National Health Laboratory Services (NHLS) national HIV cohort-a longitudinal cohort of people living with HIV accessing care in the public sector antiretroviral therapy programme in South Africa that can observe national access to HIV care through laboratory testing data. FINDINGS TO DATE: Topics addressed by the cohort include antenatal care history, HIV treatment exposure, delivery/birth management, prophylaxis and maternal blood results relevant to HIV captured at delivery. The cohort was also one of the first to describe implementation of early infant diagnosis procedures in South Africa including evaluations of novel point-of-care testing strategies demonstrating improvements in uptake of HIV care among infants accessing point-of-care services. FUTURE PLANS: Annual linkage of infant delivery and testing data to longitudinal laboratory test data in the NHLS national HIV cohort is planned to allow for analysis of both infant continuity of care outcomes and as well as evaluation of maternal-infant pair treatment and mobility outcomes in the post partum and later period.

Caesarean sections, indications and outcomes: a cross-sectional study using the Robson classification in a tertiary hospital in Sierra Leone.

OBJECTIVE: WHO recommends the use of the Robson's 'Ten Groups Classification' for monitoring and assessing caesarean section (CS) rates. The aim of this study was to investigate the rates, indications and outcomes of CS using Robson classification in a tertiary hospital in Sierra Leone. DESIGN: Cross-sectional study. SETTING: Princess Christian Maternity Hospital (PCMH), Freetown, Sierra Leone. PARTICIPANTS: All women who gave birth in PCMH from 1 October 2020 to 31 January 2021. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome: CS rate by Robson group. SECONDARY OUTCOMES: indications for CS and the newborn outcomes for each Robson group. RESULTS: 1998 women gave birth during the study period and 992 CS were performed, with a CS rate of 49.6%. Perinatal mortality was 7.8% and maternal mortality accounted for 0.5%. Two-thirds of the women entered labour spontaneously and were considered at low risk (groups 1 and 3). CS rates in these groups were very high (43% group 1 and 33% group 3) with adverse outcomes (perinatal mortality, respectively, 4.1% and 6%). Dystocia was the leading indication for CS accounting for about two-thirds of the CS in groups 1 and 3. Almost all women with a previous CS underwent CS again (95%). The group of women who give birth before term (group 10) represents 5% of the population with high CS rate (50%) mainly because of emergency conditions. CONCLUSION: Our data reveals a notably high CS rate, particularly among low-risk groups according to the Robson classification. Interpretation must consider PCMH as a referral hospital within an extremely low-resourced healthcare system, centralising all the complicated deliveries from a vast catchment area. Further research is required to assess the impact of referred obstetrical complications on the CS rate and the feasibility of implementing measures to improve the management of women with dystocia and previous CS.

Multilevel analysis of individual and community factors of awareness of obstetric fistula among women of childbearing age in Nepal: analysis of recent Nepal Demographic and Health Survey 2022 data.

BACKGROUND: According to the WHO, obstetric fistula (OBF) is an abnormal connection between the genital tract and the urinary tract that occurs as the result of obstetric trauma, typically from prolonged obstructed labour. In 2018, globally, 50 000 and 100 000 cases of OBF are reported each year. The core of activities focused on reducing fistulas depends on a review of the disorder's knowledge and the features of women at risk of having a lack of understanding. The effect of community-level factors on awareness of OBF was not yet known in Nepal. Therefore, we aimed to investigate the community-level and individual-level factors of awareness of OBF among childbearing-aged women in Nepal. METHODS: The 2022 Nepal Demographic and Health Survey data were used for this study. It included 14 845 childbearing-aged women. Because of the clustering effects of Demographic and Health Survey data and the binary nature of the outcome variable, a multilevel binary logistic regression model was applied. An adjusted OR (AOR) with a 95% CI was reported to declare the statistical significance. In addition, the model that had the lowest deviance was the one that best fit the data. RESULTS: The overall prevalence of awareness of OBF among childbearing women in Nepal was 35.9% (95% CI 35.1%, 36.7%). Educational status (women who attended secondary education (AOR=1.65; 95% CI 1.41, 3.03) and higher education (AOR=4.29; 95% CI 1.14, 36.70)), currently working status (AOR=1.85; 95% CI 1.04, 3.30), birth history (AOR=2.23; 95% CI 1.48, 4.10), media exposure (AOR=1.54; 95% CI 1.07, 3.09) and women's age from 30 to 39 (AOR=3.38; 95% CI 1.35, 8.93) and 40 to 49 years old (AOR=4.68; 95% CI 1.60, 13.67) at the individual level, as well as urban residence (AOR=1.53; 95% CI 1.99, 2.87) and high community-level media exposure (AOR=2.05; 95% CI 1.67, 2.64) at the community level were statistically significant factors with awareness of OBF. CONCLUSION: Our study revealed that awareness of OBF among childbearing-aged women in Nepal was low (35.9%). The findings of this study will assist policymakers and public health programmers in understanding the magnitude of OBF awareness and the contributory factors. In addition, it will be useful to increasing awareness of OBF in the communities and promoting primary prevention approaches through education and motivation efforts.

Comparative effectiveness trial of metformin versus insulin for the treatment of gestational diabetes in the USA: clinical trial protocol for the multicentre DECIDE study.

INTRODUCTION: Gestational diabetes mellitus (GDM) is one of the most common medical complications of pregnancy. Glycaemic control decreases the risk of adverse pregnancy outcomes for the affected pregnant individual and the infant exposed in utero. One in four individuals with GDM will require pharmacotherapy to achieve glycaemic control. Injectable insulin has been the mainstay of pharmacotherapy. Oral metformin is an alternative option increasingly used in clinical practice. Both insulin and metformin reduce the risk of adverse pregnancy outcomes, but comparative effectiveness data from a well-characterised, adequately powered study of a diverse US population remain lacking. Because metformin crosses the placenta, long-term safety data, in particular, the risk of childhood obesity, from exposed children are also needed. In addition, the patient-reported experiences of individuals with GDM requiring pharmacotherapy remain to be characterised, including barriers to and facilitators of metformin versus insulin use. METHODS AND ANALYSIS: In a two-arm open-label, pragmatic comparative effectiveness randomised controlled trial, we will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. We plan to recruit 1572 pregnant individuals with GDM who need pharmacotherapy at 20 US sites using consistent diagnostic and treatment criteria for oral metformin versus injectable insulin and follow them and their children through delivery to 2 years post partum. More information is available at www.decidestudy.org. ETHICS AND DISSEMINATION: The Institutional Review Board at The Ohio State University approved this study (IRB: 2024H0193; date: 7 December 2024). We plan to submit manuscripts describing the results of each study aim, including the pregnancy outcomes, the 2-year follow-up outcomes, and mixed-methods assessment of patient experiences for publication in peer-reviewed journals and presentations at international scientific meetings. TRIAL REGISTRATION NUMBER: NCT06445946.

Global contribution of suicide to maternal mortality: a systematic review protocol.

INTRODUCTION: Maternal suicide is a significant contributor to maternal mortality with devastating consequences for women, families and society. Maternal mortality reporting systems differ across countries and there is no up-to-date overview of maternal suicide deaths globally. This systematic review aims to synthesise the evidence on maternal suicide. The primary objective is to determine the contribution of suicide towards maternal mortality globally and explore differences between geographical regions. The secondary objectives are to summarise the availability and quality of data globally and to describe how suicide deaths are classified across different countries. METHODS AND ANALYSIS: This protocol follows the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. Medline, Embase, PsycINFO, Global Health and CINAHL databases and the grey literature were searched with no date or language restrictions. Observational studies, national surveys and reports that present data on maternal deaths due to suicide occurring during pregnancy, intrapartum and in the postpartum period will be included. Screening, data extraction and quality assessment will be conducted independently by two reviewers. Results will be summarised narratively. If sufficient outcome data are available, random-effects meta-analyses will be conducted to determine global pooled estimates of suicide-related maternal mortality rates and the proportion of maternal deaths attributable to suicide. ETHICS AND DISSEMINATION: Ethical approval is not required for this systematic review. Results will be written up for publication in a peer-reviewed journal and findings will be shared at national and international conferences. PROSPERO REGISTRATION NUMBER: CRD42023429072.

Predictors of perinatal mortality in Ghana: a systematic review protocol.

INTRODUCTION: Perinatal mortality is a major public health issue in sub-Saharan Africa, with Ghana experiencing consistently high rates. This poses challenges for achieving the maternal and child health-related sustainability development goals by 2030. While some studies have explored factors behind perinatal mortality in Ghana, a comprehensive analysis considering multifactorial predictors remains absent. This scoping review, guided by Anderson's framework of healthcare utilisation, aims to address this. The primary objective is to map the predictors of perinatal mortality in Ghana using Anderson's framework. It aims to identify interpersonal, social structural and health beliefs as predisposing factors; evaluate access to healthcare, social support and health literacy as enabling factors; and outline maternal and foetal conditions as need factors, concluding with identified knowledge gaps. METHODS AND ANALYSIS: The Cochrane handbook for systematic reviews of interventions will be used to guide the conduct of this review. Four main electronic databases, PubMed, Web of Science, Scopus and Cumulative Index for Nursing and Allied Health Literature, will be searched. Eligible studies will be charted and synthesised, focussing on Anderson's primary domains: predisposing factors, enabling factors and need factors. Studies published in the English language from January 2000 to June 2024 will be included in the study to cover the most recent factors associated with perinatal mortality in Ghana. ETHICS AND DISSEMINATION: This review will rely on already published peer-reviewed articles and therefore will not require ethical approval. The review results will be disseminated through peer-reviewed scientific publications and annual health services review conferences in Ghana. PROSPERO REGISTRATION NUMBER: CRD42024564968.

Cook's balloon versus dinoprostone for Labour induction of term pregnancies with fetal GROWth restriction: study protocol for a randomised controlled trial in tertiary maternity hospitals in Spain (COLIGROW study).

INTRODUCTION: Fetal growth restriction (FGR) affects about 3%-5% of term pregnancies. If prenatally detected and anterograde umbilical artery flow is preserved (stage I), it is recommended to deliver at term (≥ 37+0 weeks). In the absence of contraindications, the vaginal route is preferred, and labour induction is usually required. It has been postulated that mechanical methods for cervical ripening may have an optimal profile for the induction of term FGR fetuses since they are associated with less uterine stimulation than the standard pharmacological methods, and therefore, could be better tolerated by fetuses with reduced placental reserve. This study aims to evaluate whether cervical ripening with a Cook's balloon for the induction of labour from 37+0 weeks of gestation in the stage I FGR manages to increase the rate of vaginal delivery compared with vaginal dinoprostone. METHODS AND ANALYSIS: This will be an open-labelled, randomised, parallel-group clinical trial to be held in five Spanish maternities. Women aged ≥18 years with singleton pregnancies complicated with stage I FGR (defined as the presence of at least one of these two criteria: (1) estimated fetal weight (EFW) <3rd percentile; (2) EFW <10th percentile and at least one of the following: (2.1.) umbilical artery pulsatility index >95th percentile and presence of antegrade end-diastolic flow or (2.2.) Cerebroplacental ratio <5th percentile), gestational age dated by first-trimester ultrasound ≥37+0 weeks at the time of labour induction, cephalic presentation, unfavourable cervix (Bishop score <7), intact fetal membranes, no previous caesarean section and no maternal or fetal contraindications for vaginal delivery or labour induction will be 1:1 randomised by centre to labour induction with Cook's balloon (experimental arm) or dinoprostone (control arm). FGR cases with evidence of non-placental origin (major structural fetal malformations, chromosomal anomalies or congenital infection) will be excluded. The primary outcome is the achievement of a vaginal delivery and it will be assessed by comparing the rates of vaginal delivery in each group using the one-sided χ2 test at an alpha level of 0.025. The sample size has been estimated to observe an expected 84% of vaginal deliveries with Cook's balloon vs 62% with dinoprostone. Therefore, a total of 172 patients (86 per arm) are required (power of 90%, alpha level of 0.025, assuming a percentage of losses of 5%). The efficacy analysis will be performed in the intention-to-treat population. An interim analysis using a two-stage sequential design with the O'Brien-Fleming method will be applied. ETHICS AND DISSEMINATION: The trial was registered in the European Union drug regulating authorities' clinical trials database (EUDRACT) (2021-001726-22) and received approval from the local Research Ethics Committee (21/728) and the Spanish Agency of Medicines and Medical Devices (AEMPS). AEMPS classified the study as a low-intervention trial. The study will be conducted in compliance with the principles of Good Clinical Practice. The study results will be disseminated through workshops and national/international conferences and published in peer-reviewed journals. In addition, they will be disclosed to patients and the public in understandable language through study newsletters and press releases to news and social media. PROTOCOL VERSION: V.1.1, 18 May 2023. TRIAL REGISTRATION NUMBERS: EUDRACT 2021-001726-22 and NCT05774236.

The effects of proton pump inhibitors during pregnancy on treatment of preeclampsia, and related outcomes: a systematic review and meta-analysis.

OBJECTIVE: This systematic review evaluated the available evidence of the effects of PPIs during pregnancy on preeclampsia and related maternal, fetal and neonatal outcomes. DATA SOURCES: Five electronic databases (MEDLINE, Embase, CINAHL, Cochrane CENTRAL, and Global Medicus Index) were searched on 17 November 2023. STUDY ELIGIBILITY CRITERIA: Randomized controlled trials involving pregnant women, using any class or dose of PPIs, were eligible. STUDY APPRAISAL AND SYNTHESIS METHODS: Meta-analysis was conducted for all outcomes of interest, with random-effects models. Results were presented as risk ratios or mean difference. Quality assessment was performed using the Risk of Bias 2 tool, and Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) assessment was completed to evaluate the certainty of the evidence. The study was registered on PROSPERO (CRD42023423673). RESULTS: Our search identified 3,879 records, which were screened by two authors independently. Nine reports (describing eight trials) met our eligibility criteria, however six trials were ultimately excluded from our analysis as women were only given PPIs immediately prior to Cesarean section for acid aspiration prevention. The two trials included in the meta-analysis evaluated the treatment of 177 women with diagnosed preeclampsia. For the primary outcomes, moderate-certainty evidence showed there is likely no effect of the use of PPIs on risk of HELLP syndrome (RR 1.21, 95% CI 0.37 - 3.99, I²â€¯= 0%) or perinatal mortality (RR 0.81, 95% CI 0.36 - 1.79, I²â€¯= 0%), while there were insufficient data to meta-analyse all other primary outcomes, including eclampsia and neonatal mortality. No trials investigated PPIs for preventing preeclampsia. CONCLUSIONS: Given the limited outcome data we are uncertain of the effect of PPIs in women with preeclampsia. Further trials are required to determine what (if any) effects PPIs might have for preeclampsia prevention or treatment.

Association between maternal multimorbidity and neurodevelopment of offspring: a prospective birth cohort study from the Japan Environment and Children's Study.

OBJECTIVES: To investigate the association between multimorbidity during pregnancy and neurodevelopmental delay in offspring using data from a Japanese nationwide birth cohort study. DESIGN: This study was a prospective birth cohort study. SETTING: This study population included 104 059 fetal records who participated in The Japan Environment and Children's Study from 2011 to 2014. PARTICIPANTS: Pregnant women whose children had undergone developmental testing were included in this analysis. PRIMARY AND SECONDARY OUTCOME MEASURES: Neurodevelopment of offspring was assessed using the Japanese version of the Ages and Stages Questionnaire, third edition, comprising five developmental domains. The number of comorbidities among the pregnant women was categorised as zero, single disease or multimorbidity (two or more diseases). Maternal chronic conditions included in multimorbidity were defined as conditions with high prevalence among women of reproductive age. A multivariate logistic regression analysis was conducted to examine the association between multimorbidity in pregnant women and offspring development. RESULTS: Pregnant women with multimorbidity, single disease and no disease accounted for 3.6%, 30.6% and 65.8%, respectively. The ORs for neurodevelopmental impairment during the follow-up period were similar for infants of mothers with no disease comorbidity and those with a single disease comorbidity. However, the ORs for neurodevelopmental impairment were significantly higher for children born to mothers with multimorbidity compared with those born to healthy mothers. CONCLUSION: An association was observed between the number of comorbidities in pregnant women and developmental delay in offspring. Multimorbidity in pregnant women may be associated with neurodevelopmental delay in their offspring. Further research is required in this regard in many other regions of the world.

Women's health in focus: Real-world data on valproate prescriptions during pregnancy - a cohort study in Catalonia (Spain).

OBJECTIVES: To characterise the exposure to valproate within a cohort of pregnant women using electronic health records (EHRs) from Catalonia (System for the Development of Research in Primary Care, SIDIAP). DESIGN: Drug-utilisation cohort study covering the period from January 2011 to June 2020. The study included pregnancy episodes of women from Catalonia identified by the algorithm. SETTING: Data were sourced from SIDIAP, a comprehensive EHR repository that includes information from various data sources: recorded prescriptions (both hospital and primary care), diagnoses and sociodemographic characteristics identified by primary care physicians, and sexual and reproductive health data from ASSIR (used by gynaecologists and midwives). PARTICIPANTS: Women aged 12-50 with at least one pregnancy episode occurred during January 2011-June 2020 and at least a prescription of valproate during pregnancy. PRIMARY AND SECONDARY OUTCOMES: Primary outcomes included valproate exposure, measured through prevalence and cumulative incidence in pregnancy episodes and by trimester. The impact of regulatory measures (risk mitigation measures, RMMs) was assessed, and prescriptions over time were analysed using interrupted time series analysis. Secondary outcomes included health issues, pregnancy outcomes, smoking habits and socioeconomic characteristics. RESULTS: A total of 99 605 pregnancies were identified, with at least 3.03‰ (95% CI 2.69‰ to 3.39‰) exposed to valproate at some point (302 pregnancies, 276 women). The median pregnancy duration was 38.30 weeks (IQR 12.6-40.1), and the median age at pregnancy was 32.37 years (IQR 27.20-36.56). Epilepsy was the most frequent health issue. The prevalence and cumulative incidence of valproate prescriptions decreased during pregnancy and increased postpregnancy. The RMMs implemented in 2014 led to a reduction in monthly valproate prescriptions during pregnancy in this cohort. CONCLUSIONS: The study highlights the decline in valproate prescriptions during pregnancy due to RMMs and underscores the need for standardised methodologies in future studies to ensure the safety of pregnant patients and optimise scientific evidence.

Causal evidence of the association between green and blue spaces (GBS) and maternal and neonatal health: a systematic review and meta-analysis protocol.

INTRODUCTION: Previous systematic reviews investigating the effects of green and blue space (GBS) on maternal and neonatal health have mainly focused on cross-sectional evidence, limiting potential causal inferences. The last review on the topic was published in January 2024. This review focused on residential greenness effects and neonatal health only but did not include other green/blue space measures, or maternal health outcomes. This review also only included papers published up to June 2023; discounting the 15 studies that have been published since. Thus, this study will capture the growing number of studies that generate causal evidence and aims to investigate the association between GBS and maternal and/or neonatal health. METHODS AND ANALYSIS: The study protocol was developed with reference to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. This review will include study designs such as experiments, quasi-experiments, longitudinal studies and more. The study independent variable must be a GBS, green space and/or blue space measure. Eligible maternal health outcomes are those reported during pregnancy and up to 1 year after pregnancy. Neonatal health outcomes are limited to neonates no older than 28 days. A total of seven online databases will be searched: Medline, Scopus, Web of Science, PsycInfo, Embase, Environment Complete, and Maternity and Infant Care Database. Abstract and full-text screenings will be undertaken by three reviewers. Risk of bias assessment will be conducted based on the Risk of Bias in Non-randomized Studies-of Exposure framework.A narrative synthesis will be undertaken. If sufficiently comparable studies are identified, meta-analyses using random effects models will be conducted. We will explore heterogeneity using the I2 test. ETHICS AND DISSEMINATION: Ethical approval is not required as all the data will be derived from published primary studies that have already obtained ethical permissions. The findings will be disseminated through relevant conferences and peer-reviewed publications. PROSPERO REGISTRATION NUMBER: CRD42023396372.

Comparison of the effects of norepinephrine and phenylephrine on shivering and hypothermia in patients undergoing caesarean section under spinal anaesthesia at a tertiary hospital in China：a randomised, double-blind, controlled trial protocol.

INTRODUCTION: Peripheral vasodilation causes a redistribution of body temperature from the core to the periphery, resulting in shivering and hypothermia. These are normal pathological and physiological processes during spinal anaesthesia. Two drugs, norepinephrine and phenylephrine, have peripheral vasoconstrictive effects. It is unclear the effects of norepinephrine and phenylephrine on shivering and hypothermia in patients undergoing caesarean section under spinal anaesthesia. METHODS ANALYSIS: 240 eligible parturients will be recruited for this randomised, double-blind, controlled trial and randomly assigned to either the norepinephrine or phenylephrine groups. The primary outcome will be the incidence of shivering while secondary outcomes will include the severity of shivering, rectal temperature, incidence of hypothermia and umbilical artery blood pH value. ETHICS AND DISSEMINATION: The Institutional Ethics Committee of The Second People's Hospital of Hefei approved the trial protocol (ID: 2023-093). The results will be published in a compliant journal. The original data will be released in December 2029 on the ResMan original data-sharing platform of the China Clinical Trial Registry (http://www.medresman.org.cn). TRIAL REGISTRATION NUMBER: ChiCTR2300077164.

Rectal versus vaginal progesterone administration for luteal phase support in the hormone replacement therapy frozen embryo transfer (HRT-FET) cycle: protocol for a non-inferiority randomised controlled trial.

INTRODUCTION: This study compares rectal administration with vaginal administration of progesterone as luteal phase support in hormone replacement therapy frozen embryo transfer (HRT-FET) cycles. The reason for comparing the two routes of administration is that rectal administration has been suggested to be more patient friendly. METHODS AND ANALYSIS: This study is a randomised controlled trial comparing the ongoing pregnancy rate (OPR) at week 12 in HRT-FET cycles after rectal administered progesterone as the only administered progesterone compared with a vaginal luteal phase support regimen. All patients are enrolled from a Danish public fertility clinic and randomised to one of two groups, with 305 patients receiving embryo transfer assigned to each group. Endometrial preparation includes 6 mg oestradiol daily. The intervention group receives rectally administered progesterone (400 mg/12 hours) and the control group receives vaginally administered progesterone (400 mg/12 hours). If P4 is <35 nmol/L on blastocyst transfer day an additional rectal luteal phase rescue regimen is started (control group). Thawing and transferring of a single autologous vitrified blastocyst is scheduled on the sixth day of progesterone administration in both groups. The power calculation is based on a non-inferiority analysis with an expected OPR in both groups of 44% and the upper limit of a one-sided 95% CI will exclude a difference in favour of the control group of more than 10.0%. An interim analysis will be conducted once half of the study population has been enrolled. ETHICS AND DISSEMINATION: The trial was approved on 21 November 2023 by the Danish National Ethical Committee and the Danish Medicines Agency and is authorised by the Clinical Trials Information System (EUCT number 2023-504616-15-02). All patients will provide informed consent before being enrolled in the study. The results will be published in an international journal. TRIAL REGISTRATION NUMBER: EUCT number: 2023-504616-15-02.

Current status and future of genomics in fetal and maternal medicine: A scientific review commissioned by European Board and College of Obstetrics and Gynaecology (EBCOG).

This EBCOG guidance reviews the current and future status of genomics within fetal and maternal medicine. This document addresses the clinical uses of genetic testing in both screening and diagnostic testing prenatally. The role of genomics within fetal and maternal medicine is described. The research and future implications of genetic testing as well as the educational, ethical and economic implications of genomics are discussed.

Associations of air pollution exposures in preconception and pregnancy with birth outcomes and infant neurocognitive development: analysis of the Complex Lipids in Mothers and Babies (CLIMB) prospective cohort in Chongqing, China.

OBJECTIVES: To investigate the associations of traffic-related air pollution exposures in early pregnancy with birth outcomes and infant neurocognitive development. DESIGN: Cohort study. SETTING: Eligible women attended six visits in the maternity clinics of two centres, the First Affiliated Hospital of Chongqing Medical University and Chongqing Health Centre for Women and Children. PARTICIPANTS: Women who were between 20 and 40 years of age and were at 11-14 weeks gestation with a singleton pregnancy were eligible for participation. Women were excluded if they had a history of premature delivery before 32 weeks of gestation, maternal milk allergy or aversion or severe lactose intolerance. 1273 pregnant women enrolled in 2015-2016 and 1174 live births were included in this analysis. EXPOSURES: Air pollution concentrations at their home addresses, including particulate matter with diameter ≤2.5 µm (PM2.5) and nitrogen dioxide (NO2), during pre-conception and each trimester period were estimated using land-use regression models. OUTCOME MEASURES: Birth outcomes (ie, birth weight, birth length, preterm birth, low birth weight, large for gestational age and small for gestational age (SGA) status) and neurodevelopment outcomes measured by the Chinese version of Bayley Scales of Infant Development. RESULTS: An association between SGA and per-IQR increases in NO2 was found in the first trimester (OR: 1.57, 95% CI: 1.06 to 2.32) and during the whole pregnancy (OR: 1.33, 99% CI: 1.01 to 1.75). Both PM2.5 and NO2 exposure in the 90 days prior to conception were associated with lower Psychomotor Development Index scores (ß: -6.15, 95% CI: -8.84 to -3.46; ß: -2.83, 95% CI: -4.27 to -1.39, respectively). Increased NO2 exposure was associated with an increased risk of psychomotor development delay during different trimesters of pregnancy. CONCLUSIONS: Increased exposures to NO2 during pregnancy were associated with increased risks of SGA and psychomotor development delay, while increased exposures to both PM2.5 and NO2 pre-conception were associated with adverse psychomotor development outcomes at 12 months of age. TRIAL REGISTRATION NUMBER: ChiCTR-IOR-16007700.

Development of the DONOR prediction model on the risk of hypertensive complications in oocyte donation pregnancy: study protocol for a multicentre cohort study in the Netherlands.

INTRODUCTION: Oocyte donation (OD) pregnancy is accompanied by a high incidence of hypertensive complications, with serious consequences for mother and child. Optimal care management, involving early recognition, optimisation of suitable treatment options and possibly eventually also prevention, is in high demand. Prediction of patient-specific risk factors for hypertensive complications in OD can provide the basis for this. The current project aims to establish the first prediction model on the risk of hypertensive complications in OD pregnancy. METHODS AND ANALYSIS: The present study is conducted within the DONation of Oocytes in Reproduction project. For this multicentre cohort study, at least 541 OD pregnancies will be recruited. Baseline characteristics and obstetric data will be collected. Additionally, one sample of maternal peripheral blood and umbilical cord blood after delivery or a saliva sample from the child will be obtained, in order to determine the number of fetal-maternal human leucocyte antigen mismatches. Following data collection, a multivariate logistic regression model will be developed for the binary outcome hypertensive complication 'yes' and 'no'. The Prediction model Risk Of Bias ASsessment Tool will be used as guide to minimise the risk of bias. The study will be reported in line with the 'Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis' guideline. Discrimination and calibration will be determined to assess model performance. Internal validation will be performed using the bootstrapping method. External validation will be performed with the 'DONation of Oocytes in Reproduction individual participant data' dataset. ETHICS AND DISSEMINATION: This study is approved by the Medical Ethics Committee LDD (Leiden, Den Haag, Delft), with protocol number P16.048 and general assessment registration (ABR) number NL56308.058.16. Further results will be shared through peer-reviewed journals and international conferences.

Low-dose aspirin prophylaxis to prevent hypertensive disorders of pregnancy after in vitro fertilisation: a scoping review protocol.

INTRODUCTION: Pregnancies resulting from in vitro fertilisation are associated with an increased risk of developing hypertensive disorders of pregnancy, such as preeclampsia, when compared with naturally conceived pregnancies. OBJECTIVE: The efficacy of aspirin prophylaxis to reduce the incidence of preeclampsia is well established in naturally conceived pregnancies identified as high risk for developing preeclampsia. However, the efficacy of aspirin to reduce the rate of preeclampsia for all pregnancies resulting from in vitro fertilisation remains uncertain, although in vitro fertilisation conception is a well-known risk factor for preeclampsia. Therefore, the purpose of this scoping review is to provide a comprehensive overview of the current literature regarding the use of low-dose aspirin to prevent hypertensive disorders of pregnancy after in vitro fertilisation. INCLUSION CRITERIA: This review will identify all peer-reviewed published articles including pregnant women who underwent embryo transfer after in vitro fertilisation and were prescribed low-dose aspirin to reduce the risk of hypertensive disorders of pregnancy. METHODS: We have devised a comprehensive search strategy to systematically identify pertinent studies published from January 2000 until May 2024, within the Medline (PubMed interface), Embase and Scopus databases. The search strategy is based on the keywords 'aspirin,' 'pregnancy-induced hypertension,' and ('in vitro fertilization' OR 'oocyte donation' OR 'embryo transfer' OR 'donor conception'). Two reviewers will independently screen the titles, abstracts and full-text articles to select the relevant articles, using the Covidence software. ETHICS AND DISSEMINATION: No patients are involved in this study. This study aims to be published in a peer-reviewed journal and could be presented at a conference.

Does metformin prolong pregnancy in preterm pre-eclampsia? A study protocol for a South African, hospital-based double-blind, randomised, placebo-controlled trial.

INTRODUCTION: Preterm pre-eclampsia is a leading cause of maternal morbidity and mortality. The Pre-eclampsia Intervention 2 (PI 2) trial suggested that metformin sustained release (XR) may prolong gestation by a week in pregnant women undergoing expectant management (7.6 days, geometric mean ratio 1.39, 95% CI 0.99 to 1.95; p=0.057). These findings should be confirmed with a larger sample size, and we need to know if such a prolongation improves neonatal outcome. Here, we describe the protocol for such a follow-up trial. METHODS: The PI 3 trial is a phase III, intention-to-treat, double-blind, placebo-controlled randomised clinical trial to assess if metformin XR can prolong gestation and improve neonatal outcomes in women undergoing expectant management for preterm pre-eclampsia. We will recruit women who are between 26+0 and 31+6 weeks pregnant. Women will be randomised to receive either 3 g metformin XR or an identical placebo in divided daily doses. The primary outcome is prolongation of pregnancy. Secondary outcomes are neonatal birth weight and length of neonatal care admission (an indicator of neonatal health at birth). All other outcomes will be exploratory. We will record tolerability and adverse events. We plan a sample size of 500 participants to be powered for the primary and secondary outcomes. ETHICS AND DISSEMINATION: PI 3 has ethical approval (Health Research Ethics Committee 2, Stellenbosch University, Protocol number M21/03/007, Project ID 21639, Federal Wide Assurance Number 00001372, Institutional Review Board Number IRB0005239), and is registered with the Pan African Clinical Trial Registry (PACTR202104532026017) and the South African Medicine Control Council (20211211). Data will be presented at international conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: PACTR202104532026017).

Extreme weather events and maternal health in low-income and middle-income countries: a scoping review.

BACKGROUND: Despite global efforts to improve maternal health and healthcare, women throughout the world endure poor health during pregnancy. Extreme weather events (EWE) disrupt infrastructure and access to medical services, however little is known about their impact on the health of women during pregnancy in resource-poor settings. OBJECTIVES: This review aims to examine the current literature on the impact of EWE on maternal health to identify the pathways between EWE and maternal health in low-income and middle-income countries to identify gaps. ELIGIBILITY CRITERIA: Studies were eligible for inclusion if they were published before 15 December 2022 and the population of the studies included pregnant and postpartum women (defined at up to 6 weeks postpartum) who were living in low-income and middle-income countries. The exposure of the included study must be related to EWE and the result to maternal health outcomes. SOURCES OF EVIDENCE: We searched the literature using five databases, Medline, Global Health, Embase, Web of Science and CINAHL in December 2022. We assessed the results using predetermined criteria that defined the scope of the population, exposures and outcomes. In total, 15 studies were included. CHARTING METHODS: We identified studies that fit the criteria and extracted key themes. We extracted population demographics and sampling methodologies, assessed the quality of the studies and conducted a narrative synthesis to summarise the key findings. RESULTS: Fifteen studies met the inclusion criteria. The quantitative studies (n=4) and qualitative (n=11) demonstrated an association between EWE and malnutrition, mental health, mortality and access to maternal health services. CONCLUSION: EWE negatively impact maternal health through various mechanisms including access to services, stress and mortality. The results have demonstrated concerning effects, but there is also limited evidence surrounding these broad topics in low-resource settings. Research is necessary to determine the mechanisms by which EWE affect maternal health. PROSPERO REGISTRATION NUMBER: CRD42022352915.

High-resolution mapping of essential maternal and child health service coverage in Nigeria: a machine learning approach.

BACKGROUND: National-level coverage estimates of maternal and child health (MCH) services mask district-level and community-level geographical inequities. The purpose of this study is to estimate grid-level coverage of essential MCH services in Nigeria using machine learning techniques. METHODS: Essential MCH services in this study included antenatal care, facility-based delivery, childhood vaccinations and treatments of childhood illnesses. We estimated generalised additive models (GAMs) and gradient boosting regressions (GB) for each essential MCH service using data from five national representative cross-sectional surveys in Nigeria from 2003 to 2018 and geospatial socioeconomic, environmental and physical characteristics. Using the best-performed model for each service, we map predicted coverage at 1 km2 and 5 km2 spatial resolutions in urban and rural areas, respectively. RESULTS: GAMs consistently outperformed GB models across a range of essential MCH services, demonstrating low systematic prediction errors. High-resolution maps revealed stark geographic disparities in MCH service coverage, especially between rural and urban areas and among different states and service types. Temporal trends indicated an overall increase in MCH service coverage from 2003 to 2018, although with variations by service type and location. Priority areas with lower coverage of both maternal and vaccination services were identified, mostly located in the northern parts of Nigeria. CONCLUSION: High-resolution spatial estimates can guide geographic prioritisation and help develop better strategies for implementation plans, allowing limited resources to be targeted to areas with lower coverage of essential MCH services.