Study protocol to explore the social effects of environmental exposure and lifestyle behaviours on pregnancy outcome: an overview of cohort of pregnant women study.

INTRODUCTION: A growing number of international studies have highlighted the adverse consequences of lived experience in the first thousand days of pregnancy and early life on the probability of stillbirth, child mortality, inadequate growth and healthy development during both childhood and adulthood. The lived experience of the fetus inside the womb and at the birth is strongly related to both maternal health during pregnancy and maternal exposure to a set of environmental factors known as 'exposome' characteristics, which include environmental exposure, health behaviours, living conditions, neighbourhood characteristics and socioeconomic profile. The aim of our project is to explore the relationships between exposome characteristics and the health status of pregnant women and their newborns. We are particularly interested in studying the relationships between the social inequality of adverse pregnancy outcomes and (1) short-term exposure to atmospheric pollution (MobiFem project) and (2) pregnancy lifestyle (EnviFem project). METHODS AND ANALYSIS: Ours is a prospective, observational and multisite cohort study of pregnant women, involving one teaching hospital across two sites in the Strasbourg metropolitan area.The research team at University Hospital of Strasbourg (HUS) Health collects data on outcomes and individual characteristics from pregnancy registries, clinical records data and questionnaires administered via email to study participants. Recruitment began in February 2021 and will be complete by December 2021. Participants are recruited from first trimester antenatal ultrasound examinations (conducted on weekdays across both sites); each woman meeting our inclusion criteria enters the cohort at the end of her first trimester. Study participants receive a total of three online questionnaires covering sociodemographic characteristics, travel behaviour patterns and lifestyle. Participants complete these questionnaires at recruitment, during the second and third trimester. The level of personal exposure to air pollution is characterised using a dynamic spatiotemporal trajectory model that describes the main daily movements of pregnant women and the time spent in each place frequented. Univariate, multilevel and Bayesian model will be used to investigate the relationships between exposome characteristics and the health status of pregnant women and their newborns. ETHICS AND DISSEMINATION: Our research was approved by the Commission de Protection des Personnes (CPP) Ile de France VI (Paris) on 9 December 2020 (File reference No. 20.09.15.41703 ID RCB: 2020-A02580-39 and No. 20 080-42137 IDRCB 2020-A02581-38). The Agence Nationale de Sécurité du Médicament was informed of it on 15 December 2020. Findings from the study will be disseminated through publications and international conferences and through presentation at meetings with local stakeholders, researchers and policy-makers. TRIAL REGISTRATION NUMBERS: NCT04705272, NCT04725734.

Externally Validated Score to Predict Cesarean Delivery After Labor Induction With Cervi Ripening.

OBJECTIVE: To build a score to predict the risk of cesarean delivery after labor induction with cervical ripening, and to compare its predictive capacities with other already existing scores. METHODS: This study is a secondary analysis of data collected in the prospective multicenter observational French population-based cohort study Methods of Induction of Labor and Perinatal Outcomes, the primary objective of which was to obtain national data regarding labor induction practices in 94 maternity units. A total of 1,692 patients were randomly split into a derivation data set of 1,024 patients (60%) and an internal validation set of 668 patients (40%). Statistical analyses were performed using a Bayesian approach, allowing the use of priors (ie, previous results published in the literature). The final score is a simplified 50-point score. The score was validated using the internal validation set and an external data set of 4,242 patients from the National Institutes of Health's Consortium for Safe Labor database. We compared the area under the curve (AUC) of our score with two other scores: the modified Bishop score and the Levine score, which is a recently published risk calculator for cesarean delivery after labor induction with unfavorable cervix. RESULTS: In the multivariate analysis, height, body mass index, gestational age, parity, dilation, effacement, fetal head station, medical indication, suspicion of macrosomia, premature rupture of membranes and concerning fetal status were found to be strongly associated with cesarean delivery. The AUC in the derivation set and internal validation set were 0.76 (0.73-0.79) and 0.74 (0.70-0.78), respectively. On the external validation set, the AUC for the present score, the Levine score, and the modified Bishop score were 0.81 (0.79-0.82), 0.76 (0.75-0.78), and 0.74 (0.73-0.76), respectively. CONCLUSION: Our easy-to-use, externally validated score is efficient in predicting cesarean delivery after labor induction with cervical ripening. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02477085.

Neonatal Morbidity After Management of Vaginal Noncephalic Second-Twin Delivery by Residents.

OBJECTIVE: To assess neonatal mortality and morbidity according to whether a resident or senior obstetrician initially managed vaginal delivery of noncephalic second twins. METHODS: The JUmeaux MODe d'Accouchement study was a national, prospective, population-based, cohort study of twin deliveries in 176 maternity units in France, where active management of second-twin delivery is recommended. The primary outcome of our study was a composite of neonatal mortality and morbidity. Neonatal outcomes of noncephalic second twins born at or after 32 weeks of gestation after vaginal delivery of the first twin were compared according to the initial managing practitioner-supervised resident or senior obstetrician. Deliveries performed by a senior obstetrician after failure by a resident were classified as resident deliveries. Deliveries in maternity units without residents were excluded. We used multilevel multivariable Poisson regression models and propensity score matching to control for indication bias and potential confounders, including the maternity unit status. We performed subgroup analyses according to gestational age at delivery, before or after 37 weeks of gestation, and to the noncephalic second twin presentation, breech or transverse. RESULTS: Among 1,376 noncephalic second-twin deliveries, 545 (39.6%) were initially managed by a resident and 831 (60.4%) by a senior obstetrician. Residents failed to deliver the second twin in 125 (22.9%) women. Composite neonatal mortality and morbidity did not differ between the resident and senior groups (13/545 [2.4%] vs 29/831 [3.5%]; adjusted relative risk 0.78, 95% CI 0.35-1.74). Subgroup analyses were consistent with the overall analysis. CONCLUSION: Supervised resident and senior staff management of noncephalic second-twin vaginal delivery is associated with similar neonatal morbidity and mortality, which supports continued training of residents in such deliveries.

Improving the Prediction of Neonatal Outcomes in Isolated Left-Sided Congenital Diaphragmatic Hernia by Direct and Indirect Sonographic Assessment of Liver Herniation.

OBJECTIVES: Liver herniation can be assessed sonographically by either a direct (liver-to-thoracic area ratio) or an indirect (stomach position) method. Our objective was to evaluate the utility of those methods to assess liver herniation for the prediction of neonatal outcomes in patients with isolated left-sided congenital diaphragmatic hernia (CDH). METHODS: We conducted a retrospective cohort study of all patients with CDH who had prenatal assessment and were delivered at Texas Children's Hospital between January 2004 and April 2014. The predictive value of sonographic parameters for mortality and the need for extracorporeal membrane oxygenation was evaluated by univariate, multivariate, and factor analysis and by receiver operating characteristics curves. RESULTS: A total of 77 fetuses with isolated left-sided CDH were analyzed. The lung-to-head ratio, liver-to-thorax ratio, and stomach position (according to the classifications of Kitano et al [Ultrasound Obstet Gynecol 2011; 37:277-282] and Cordier et al [J Matern Fetal Neonatal Med 2015; 28:190-195]) were significantly associated with both neonatal outcomes (P < .03). Significant correlations were observed between all of these sonographic parameters. A combination of the liver-to-thorax ratio and stomach position (Kitano) or stomach position (Cordier) with the lung-to-head ratio increased the area under the receiver operating characteristic curve of the lung-to-head ratio for mortality prediction (0.86 [95% confidence interval, 0.74-0.98], 0.83 [0.72-0.95], and 0.83 [0.74-0.92], respectively). CONCLUSIONS: Sonographic measurements of liver herniation (liver-to-thorax ratio and stomach position) are predictive of neonatal outcomes in isolated left-sided congenital diaphragmatic hernia. Our study shows that the combination of those sonographic measurements of liver herniation and lung size improves the accuracy of predicting mortality in those fetuses.

Predictive value of cardiovascular parameters in stages 1 and 2 of twin-to-twin transfusion syndrome.

OBJECTIVE: The Quintero staging of twin-to-twin transfusion syndrome (TTTS) does not include a comprehensive cardiovascular assessment. The aim of this study is to assess the predictive value of the myocardial performance index (MPI) and the Children's Hospital of Philadelphia (CHOP) score on recipient survival in Quintero stages 1 and 2 TTTS. METHODS: The cohort study was based on prospectively collected data between May 2008 and February 2013 in a population of stages 1 and 2 TTTS. Comparisons between groups were carried out using Student's t-test and χ(2)-test. A stepwise ascending multivariate logistic regression model was then built. RESULTS: A total of 73 pregnancies in stages 1 and 2 of Quintero's classification were treated with laser. Rates of recipient fetal losses were higher when MPI was above 0.43 ms (71.4% vs 28.6%, p = 0.022). Rate of CHOP score above 5 was higher in the fetal loss group (28.6% vs 5.1%, p = 0.022). After adjustment for Quintero stages 1 or 2, the risk of recipient loss rate is higher according to CHOP score [OR 7.6; 95% confidence interval (CI) 1.3-43.5] or MPI value (OR 3.7; 95% CI 1.0-13.9). CONCLUSION: The CHOP score and MPI are correlated with the recipient survival in stages 1 and 2 TTTS.