Methods of induction of labor in women with obesity: A secondary analysis of two multicenter randomized controlled trials.

INTRODUCTION: Obesity is an increasing public health concern worldwide and can lead to more complications in pregnancy and childbirth. Women with obesity more often require induction of labor for various indications. The aim of this study is to assess which method of induction of labor is safest and most effective in women with obesity. MATERIAL AND METHODS: This is a secondary analysis of two randomized controlled trials about induction of labor. Women with a term singleton pregnancy in cephalic presentation, an unfavorable cervix, intact membranes and without a previous cesarean section were randomly allocated to cervical priming with a Foley catheter or vaginal prostaglandin-E2-gel (PROBAAT-I) or a Foley catheter or oral misoprostol (PROBAAT-II). The inclusion and exclusion criteria for the studies were identical. Induction methods were compared in women with obesity (body mass index ≥30.0). Main outcomes were cesarean section and postpartum hemorrhage (blood loss >1000 mL). RESULTS: A total of 2664 women, were included in the trials, 517 of whom were obese: 254 women with obesity received a Foley catheter, 176 oral misoprostol and 87 prostaglandin E2 (PGE2). A cesarean section was performed in 29.1% of women allocated to Foley vs 22.2% in the misoprostol and 23.0% in the PGE2 groups. Comparisons between groups revealed no statistically significant differences: the relative risk [RR] was 1.31 (95% confidence interval [CI] 0.94-1.84) in the Foley vs misoprostol group and 1.27 (95% CI 0.83-1.95) in the Foley vs PGE2 group. The rates of postpartum hemorrhage were comparable (10.6%, 11.4% and 6.9%, respectively; P = 0.512). In women with obesity, more often a switch to another method occurred in the Foley group, (20.1% vs 6.3% in misoprostol vs 1.1% in the PGE2 group; P < 0.001). The risk of a failed Foley placement was higher in women with obesity than in women without obesity (8.3% vs 3.2%; adjusted odds ratio 3.12, 95% CI 1.65-5.90). CONCLUSIONS: In women with obesity we found a nonsignificant trend towards an increased rate of cesarean sections in the group induced with a Foley catheter compared to oral misoprostol; however, the study lacked power for this subgroup analysis. The finding of a higher risk of failed placement of a Foley catheter in women with obesity can be used in shared decision making.

Telemonitoring for COVID-19 positive pregnant women; feasibility and user experience of SAFE@home Corona: prospective pilot study.

BACKGROUND: COVID-19 has catalysed digital innovations enabling remote healthcare. Pregnant women are at increased risk for severe course of COVID-19 infection. Also, the pandemic has a negative emotional impact on pregnant women as they worry about their own health and the health of their unborn child. We developed a telemonitoring platform called SAFE@home-corona consisting of a pulse oximeter and an app with symptom checklist. The aim of this study was to examine the feasibility, defined by compliance to the platform and by monitoring the course of COVID-19, patient satisfaction and user experience of a telemonitoring platform in COVID-19 positive pregnant women in the Netherlands. METHODS: We conducted a prospective pilot study among Dutch-speaking COVID-19 symptomatic pregnant women. Women were asked to monitor their oxygen-saturation with a pulse oximeter and COVID-related complaints with an in-app questionnaire daily. Oxygen-saturation and complaints were monitored by the Medical Management Centre with triage protocol. COVID-19, pregnancy, and user experience data were collected. To assess feasibility, compliance of daily self-monitoring and compliance of all intended measurements were calculated. Severity of COVID-19 was assessed via the platform and medical record. Patient satisfaction and user experience were measured through a self-developed questionnaire. RESULTS: Twenty-eight women were eligible of which 27 (93.1%) completed the study. Compliance of daily measurement and all intended measurements was high with 98.9 and 93.9%, respectively. Six women were hospitalized, of whom one to the intensive care unit. Overall, women indicated high satisfaction scores, varying from 8 to 10/10. Women were more concerned for the health of their unborn child or family then for themselves (66.7%). They stated that the platform offered reassurance. Patients would highly recommend the platform to pregnant peers during COVID infection. CONCLUSIONS: This pilot study demonstrated feasibility of the SAFE@home-corona platform for self-monitoring COVID-19 course in pregnant women. Patients were satisfied, it offered reassurance, women would recommend use to peers. Upscaling the platform is needed to draw conclusions from the early signalling abilities and to keep evaluating patient satisfaction. The platform has great potential for self-monitoring of COVID-19 and possibly other pulmonary infections in pregnant women.