Out-CRIB pilot study: a prospective two-center study of women’s acceptability of outpatient balloon induction of labor

Outpatient balloon cervical ripening has been implemented in several countries for selected low-risk pregnancies. In France, little is known about women’s willingness to consider such a pathway. We therefore conducted a prospective bicentric pilot study to assess women’s acceptability of a hypothetical outpatient balloon induction of labor (IOL) pathway among women undergoing standard inpatient balloon cervical ripening. This prospective bicentric non-comparative study was conducted from May 2023 to January 2024 in the maternity units of Nantes University Hospital and Vendée Departmental Hospital. Pregnant women with a singleton pregnancy and an indication for IOL from 37 + 0 weeks of gestation who underwent balloon catheter cervical ripening under standard inpatient care were eligible. Before balloon insertion, women were asked whether they would have been interested in outpatient management (primary outcome) and completed the EQ-5D-5 L quality-of-life questionnaire; their experience of induction was assessed after delivery with the French version of the EXIT questionnaire. Maternal and neonatal outcomes were recorded as contextual descriptive data only; the study was not designed to evaluate the safety, efficacy, or feasibility of outpatient IOL. Of the 150 eligible women to whom the questionnaire was distributed, 75 (50.0%) returned it and were included. Overall, 49.3% ( n = 37) reported that they would have accepted outpatient induction of labor, 25.3% ( n = 19) were undecided, and 25.3% ( n = 19) would not have accepted it. Among the 38 women who were undecided or would have declined, the main concerns were fear of pelvic discomfort ( n = 16, 42.1%), concern for the baby’s health ( n = 15, 39.5%), and fear of feeling isolated ( n = 14, 36.8%). Exploratory comparisons did not identify any significant factor associated with acceptance or refusal, although the study was underpowered for predictive analyses. After delivery, 68 (90.7%) and 72 (96.0%) women completed the EQ-5D-5 L and EXIT questionnaires, respectively, and overall satisfaction with childbirth was high (median score 4.0 [4.0; 5.0] on a 5-point scale). In this bicentric pilot study conducted under standard inpatient care, nearly half of women reported that they would have considered outpatient balloon IOL. These findings support the relevance of future interventional studies in carefully selected low-risk pregnancies, but they do not allow conclusions regarding the safety, efficacy, or logistical feasibility of outpatient balloon IOL.