Comparison of efficacy of oral misoprost solution versus vaginal misoprost tablets for induction of labour

The study will be conducted at the Department of Obstetrics and Gynaecology, King George’s Medical University, Lucknow, involving all antenatal women admitted. The study design is a prospective comparative study, with a sample size of 94 each group. The inclusion criteria include singleton live pregnancy, 34 weeks gestation, Bishop score 6, intact membranes, cephalic presentation, and reassurance fetal heart rate. Patients who give written informed consent will be included. Exclusion criteria include hypersensitivity to misoprostol, previous cesarean delivery or other uterine surgery, uterine contractions, and significant maternal cardiac, renal, or liver disease. All women fulfilling the included and exclusion criteria will be enrolled in the study. They will be randomly divided into treatment groups (hourly titrated-dose or static dose every 2 hours) using computer-generated numbers. Labor management will follow standard protocol, including electronic fetal monitoring. Intramuscular or intravenous analgesia will be given for pain relief during labor, and delivery will be carried out under the supervision of a consultant. Oral misoprostol solution will be administered as a 1-mg/mL solution prepared from a 200-mg misoprostol tablet dissolved in 200 mL water. The hourly titrated-dose group will receive 20-mg oral misoprostol administered hourly for 4 doses, while the static-dose group will receive 25 mg oral misoprostol administered every 2 hours for a maximum of 12 doses or until the onset of regular uterine activity. No further misoprostol will be given once regular uterine activity was observed. If contractions became inadequate, oxytocin will be provided 2 hours after the last misoprostol dose. The primary outcome is successful labor induction, defined as vaginal delivery within 24 hours after treatment initiation. Secondary outcomes include rate of cesarean delivery and need for oxytocin augmentation. Safety outcomes include incidence of maternal morbidity and adverse neonatal outcomes. Data analysis will be performed using IBM SPSS 26.0 or above software. Dichotomous variables will be compared between groups using Fisher’s exact test, while continuous variables will be compared using Chi-square test, paired t-test, and Independent Samples t-test. Confidence level of the study will be kept at 95%.