Effectiveness and Costs of Molecular Screening and Treatment for Bacterial Vaginosis to Prevent Preterm Birth: The AuTop Randomized Clinical Trial.

Importance: Bacterial vaginosis (BV) is a well-known risk factor for preterm birth. Molecular diagnosis of BV is now available. Its impact in the screening and treatment of BV during pregnancy on preterm births has not been evaluated to date. Objective: To evaluate the clinical and economic effects of point-of-care quantitative real-time polymerase chain reaction screen and treat for BV in low-risk pregnant women on preterm birth. Design, Setting, and Participants: The AuTop trial was a prospective, multicenter, parallel, individually randomized, open-label, superiority trial conducted in 19 French perinatal centers between March 9, 2015, and December 18, 2017. Low-risk pregnant women before 20 weeks' gestation without previous preterm births or late miscarriages were enrolled. Data were analyzed from October 2021 to November 2022. Interventions: Participants were randomized 1:1 to BV screen and treat using self-collected vaginal swabs (n = 3333) or usual care (n = 3338). BV was defined as Atopobium vaginae (Fannyhessea vaginae) load of 108 copies/mL or greater and/or Gardnerella vaginalis load of 109 copies/mL or greater, using point-of-care quantitative real-time polymerase chain reaction assays. The control group received usual care with no screening of BV. Main Outcomes and Measures: Overall rate of preterm birth before 37 weeks' gestation and total costs were calculated in both groups. Secondary outcomes were related to treatment success as well as maternal and neonate health. Post hoc subgroup analyses were conducted. Results: Among 6671 randomized women (mean [SD] age, 30.6 [5.0] years; mean [SD] gestational age, 15.5 [2.8] weeks), the intention-to-treat analysis of the primary clinical and economic outcomes showed no evidence of a reduction in the rate of preterm birth and total costs with the screen and treat strategy compared with usual care. The rate of preterm birth was 3.8% (127 of 3333) in the screen and treat group and 4.6% (153 of 3338) in the control group (risk ratio [RR], 0.83; 95% CI, 0.66-1.05; P = .12). On average, the cost of the intervention was €203.6 (US $218.0) per participant, and the total average cost was €3344.3 (US $3580.5) in the screen and treat group vs €3272.9 (US $3504.1) in the control group, with no significant differences being observed. In the subgroup of nulliparous women (n = 3438), screen and treat was significantly more effective than usual care (RR, 0.62; 95% CI, 0.45-0.84; P for interaction = .003), whereas no statistical difference was found in multiparous (RR, 1.30; 95% CI, 0.90-1.87). Conclusion and Relevance: In this clinical trial of pregnant women at low risk of preterm birth, molecular screening and treatment for BV based on A vaginae (F vaginae) and/or G vaginalis quantification did not significantly reduce preterm birth rates. Post hoc analysis suggests a benefit of screen and treat in low-risk nulliparous women, warranting further evaluation in this group. Trial Registration: ClinicalTrials.gov Identifier: NCT02288832.

Prophylactic manual rotation of occiput posterior and transverse positions to decrease operative delivery: the PROPOP randomized clinical trial.

BACKGROUND: Persistent occiput posterior and occiput transverse positions are the most common malpositions of the fetal head during labor and are associated with prolonged second stage of labor, cesarean deliveries, instrumental deliveries, severe perineal tears, postpartum hemorrhage, and chorioamnionitis. Manual rotation is one of several strategies described to deal with these malpositions. OBJECTIVE: This study aimed to determine if the trial of prophylactic manual rotation at the early second stage of labor is associated with a decrease in operative deliveries (instrumental and/or cesarean deliveries). STUDY DESIGN: We conducted a multicenter, open-label, randomized controlled trial in 4 French hospitals. Women with singleton term pregnancy and occiput posterior or occiput transverse position confirmed by ultrasound at the early second stage of labor and with epidural analgesia were eligible. Women were randomly assigned (1:1) to either undergo a trial of prophylactic manual rotation of occiput posterior or occiput transverse position (intervention group) or no trial of prophylactic manual rotation (standard group). The primary outcome was operative delivery (instrumental and/or cesarean deliveries). The secondary outcomes were length of the second stage of labor, maternal complications (postpartum hemorrhage, operative complications during cesarean delivery, episiotomy and perineal tears), and neonatal complications (Apgar score of <5 at 10 minutes, arterial umbilical pH of <7.10, neonatal injuries, neonatal intensive care unit admission). The main analysis was focused on intention-to-treat analysis. RESULTS: From December 2015 to December 2019, a total of 257 women (mean age, 30.4 years; mean gestational age, 40.1 weeks) were randomized: 126 were assigned to the intervention group and 131 were assigned to the standard group. Operative delivery was significantly less frequent in the intervention group compared with the standard group (29.4% [37 of 126] vs 41.2% [54 of 131]; P=.047; differential [intervention-standard] [95% confidence interval] = -11.8 [-15.7 to -7.9]; unadjusted odds ratio [95% confidence interval] = 0.593 [0.353-0.995]). Women in the intervention group were more likely to have a significantly shorter second stage of labor. CONCLUSION: Trial of prophylactic manual rotation of occiput posterior or occiput transverse positions during the early second stage of labor was statistically associated with a reduced risk of operative delivery. This maneuver could be a safe strategy to prevention operative delivery.

Objective assessment of obstetrics residents' surgical skills in caesarean: Development and evaluation of a specific rating scale.

OBJECTIVE: To develop a modified version of Objective Structured Assessment of Technical Skill (OSATS) rating scale for evaluation of surgical skills specific to caesarean and to assess its relevance in documenting the residents' learning curve during their training. Secondarily, to verify the scale's stability to caesarean's level of difficulty and comparing self-assessment to hetero-assessment in order to propose a practical application of this rating scale during residency. STUDY DESIGN: We conducted a multicentre observational prospective study, from May 2018 to November 2018. All residents at that time could participate and fill in the rating scale after caesarean. Senior surgeons had to fill in the same rating scale. We analysed correlation between self-assessments and hetero-assessments and sensitivity to change of the rating scale. Analysis of feature's relevance was performed by principal component analysis, factor analysis and reliability analysis. RESULTS: In total, 234 rating scales were completed evaluating 18 residents. Our study demonstrated that our rating scale could be used to evaluate surgical skills of residents during caesarean and distinguish their year of residency (p < 0.001) with a high correlation between self and hetero-assessment (Intraclass Correlation coefficient for global score: 0.78; 95% CI 0.68-0.86). The principal component analysis revealed two dimensions corresponding to the two parts of the rating scale and the factorial analysis allowed us to confirm distribution of features according to these two dimensions. Cronbach's alpha allowed us to highlight the percentage of representation of the scale's features in relation to all potential theoretical features (0.93, 95% CI 0.82-0.95). CONCLUSION: Our rating scale could be used for self-assessment during residency and as a hetero-assessment tool for validating defined stages of the internship.

Is failure of fetal head engagement during previous delivery a contraindication for trial of labor: A French retrospective study.

OBJECTIVE: To study whether history of cesarean delivery for arrest of descent (failure of fetal head engagement or unsuccessful instrumental delivery), is a factor of unsuccessful vaginal birth after cesarean delivery. METHODS: Multicenter prospective study of patients undergoing TOL after previous caesarean delivery between May 2012 and May 2013 in 6 maternities. Univariate statistical analysis was performed depending of previous cesarean delivery indication. Multivariate analysis was used to determine independent association between these factors and TOLAC success. RESULTS: Four hundred and eighty women with previous cesarean delivery were included and separated into two groups: the study group was composed of patients with history of CD for arrest of descent (failure of fetal head engagement or unsuccessful instrumental delivery) (n=31); control group included all other indications for CD (n=449). Overall, of the 480 women included in the study, 71.2 % underwent a TOL for a subsequent delivery (n=342): 68 % in the study group (n=21) vs 71.5 % in the control group (n=321). Vaginal birth after cesarean (VBAC) was obtained in 66.6 % vs 61% in the study and control group respectively (p=0.656). Univariate analysis of factors that may influence the success rate of (VBAC) did not show any difference between the two groups. Multivariate analysis showed that VBAC was only significantly associated with history of vaginal delivery subsequent to prior CD for arrest of descent. CONCLUSION: This study reassures us in our clinical practice allowing TOL in cases of history of CD for fetal head engagement failure or instrumental delivery failure in the second stage of labor.