This study has been designed to compare the dosing schedule of dinoprostone intracervical gel six hourly and twelve hourly interval in promoting cervical ripening and achieve vaginal delivery. Therby reducing cesarean section rate.

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Dinoprostone intracervical gel: In both groups, participants will be monitored according to the institutional protocol for induction of labour, including assessment of Bishop score, uterine contractions, fetal heart rate, and maternal and fetal well‐being. Oxytocin augmentation and other obstetric interventions will be undertaken as clinically indicated. Control Intervention1: Intracervical dinoprostone gel: Intervention Arm A (6‐hourly regimen): Dinoprostone intracervical gel 0.5 mg administered intracervically every 6 hours, up to a maximum of three doses (0, 6, and 12 hours), unless active labour is established earlier or further administration is contraindicated. Control Intervention2: Dinoprostone intracervical gel 12 hourly regimen: Intervention B(12hrly gel) Dinoprostone intracervical gel 0.5 mg administered intracervically every 12 hours, up to a maximum of three doses (0, 12, and 24 hours), unless active labour is established earlier or further administration is contraindicated. CONDITION: PRIMARY OUTCOME: To compare proportion of women achieving onset of active labour between 6 hourly verus 12 hourly regimens of dinoprostone gel for induction of labour at term pregnancy in primigravidasTimepoint: To compare proportion of women achieving onset of active labour between 6 hourly verus 12 hourly regimens of dinoprostone gel for induction of labour within 48 hours SECONDARY OUTCOME: Mode of delivery vaginal or cesarean section.Timepoint: Requirement of doses of dinoprostone gel to achieve active labour ; Timepoint: How much doses needed out of 3 within 24 hours INCLUSION CRITERIA: Primigravidas with term pregnancy and fulfilling the criteria of induction of labor with valid indication of induction of labour
Epistemonikos ID: 922f7a9140f72184c4101846c325e778cebcfa0e
First added on: Oct 08, 2026