We evaluate the likelihood of cesarean delivery and identify risks of retaining a sustained-release dinoprostone vaginal insert beyond 12 hours. In a secondary analysis of outcomes, data were collected during a large, randomized trial comparing different sustained-release prostaglandin vaginal inserts for labor induction. Outcomes were compared between cases in whom the dinoprostone insert was removed early (within 12 hours) or late (12 to 24 hours). A total of 431 subjects had the dinoprostone vaginal insert in place for 12 to 24 hours ( N = 226, 52.4%) or within 12 hours ( N = 205, 47.6%). Insert removal for labor complications was less frequent in the late group than in the early group (5.8% versus 21.5%; P ≤ 0.001). Abnormal uterine contractility patterns were less common in the late than early group (25.2% versus 37.6%; P = 0.03). Rates of cesarean delivery during the first hospitalization were similar for late and early groups (25.0% versus 29.2%; P = 0.33). Percentages of infants requiring immediate attention or intensive care were low and similar between groups. Sustained-release intravaginal dinoprostone left in place beyond 12 hours did not increase the risks of intrapartum complications, cesarean delivery, or immediate adverse neonatal events.
Trial registration: ClinicalTrials.gov NCT00308711.
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