Misoprostol: Oral vs. Vaginal Routes Compared for Labor Induction Efficacy and Safety

Labor induction is a common obstetric procedure, often necessitated by maternal or fetal indications, particularly in cases of post-term pregnancy or prelabor rupture of membranes. Current methods, while effective, can vary in their safety profiles, patient comfort, and pharmacokinetic characteristics. Misoprostol, a synthetic prostaglandin E1 analog, is widely used for cervical ripening and uterine contractions, but the optimal route of administration (oral vs. vaginal) regarding efficacy, safety, and patient experience remains a subject of ongoing clinical debate. Understanding the precise pharmacokinetic (PK) and pharmacodynamic (PD) differences between these routes is crucial for optimizing clinical protocols and improving patient outcomes, addressing a key gap in evidence-based obstetric practice.

This randomized controlled clinical trial, named IMPROVE, aims to enroll an estimated 80 pregnant women at or beyond 37+0 completed weeks gestation who are undergoing labor induction. The study will compare two routes of misoprostol administration: buccal (oral mucosa) versus vaginal epithelium. Primary outcomes include both efficacy (e.g., successful labor induction, time to delivery) and safety (e.g., adverse events, maternal and fetal complications). A sub-cohort will undergo pharmacokinetic (PK) parameter assessment to evaluate drug absorption and metabolism differences between the routes. The study design is a direct comparison to inform clinical decision-making.