Randomized Double-Blinded Comparison of Titrated Oral Versus Vaginal Misoprostol for Labor Induction [24N]

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For labor induction of an unfavorable cervix, we propose oral misoprostol, titrated to uterine response, to maximize safety and efficacy, based upon past studies.


Randomized double-blinded study. Identically appearing oral and vaginal study dosages were prepared containing either 25mcg misoprostol or placebo. The pharmacist randomized the study participants to receive either an “oral packet” (oral misoprostol, vaginal placebo) or a “vaginal packet” (opposite). Patients received both an oral protocol (quantity of capsules titrated to uterine contractions, every 2hrs) and vaginal protocol (25mcg/placebo every 4hrs) simultaneously. Providers and patients were blinded.


Un-blinding revealed 28 oral and 22 vaginal participants, with four oral, and five vaginal participants removed (imperfect consent forms, missing data). Confounding variables had no statistical significance. Primary outcomes: 1) Time to Bishop Score > 7: Titrated oral route was 9.94 hours (Standard Deviation 5.149, 95%CI 6.82-13.05). Vaginal route was 6.59 hours (SD 1.826, 95%CI 5.06-8.11). 2) Time to NSVD: Titrated oral route was 15.52 hours (SD 5.862, 95%CI 11.98-19.06). Vaginal route was 12.74 hours (SD 4.790, 95%CI 8.74-16.74). 3) Change in Bishop score: Titrated oral route was 3.39; Vaginal route was 5.25. Several safety parameters and side effects were evaluated, showing a trend towards the oral route being safer. Approximately 25% of the oral route participants reached the maximum oral dose of 75 mcg, and none needed dosage reduction. Approximately 80% of all participants preferred oral administration because they disliked vaginal placement, while 20% preferred the vaginal administration because it “worked better” and they “dislike pills.”


Results suggest our oral titrated protocol has less efficacy and side effects, although numbers didn’t reach statistical significance. Patients had strong preferences for the oral route. There is potential for future studies based upon our study. With a thorough review of recent studies, we can redesign our study in many ways, including a higher dose of oral misoprostol.

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