CompletedNot Applicable

Labor Induction With Oral Versus Vaginal Misoprostol

United States2,546 participantsStarted 2021-05-24

Plain-language summary

This study will compare vaginal and oral misoprostol, to determine whether a vaginal misoprostol regimen achieves a higher vaginal delivery rate in a real-world, high-volume setting, and whether this regimen reduces time and oxytocin need on a high-volume Labor and Delivery unit at Parkland Hospital. Our primary hypothesis is that among women with singleton, term pregnancies, cervical dilation 2cm or less, and indicated labor induction, the rate of vaginal delivery is significantly increased when a standardized vaginal misoprostol regimen is used, compared with a standardized oral misoprostol regimen.

Who can participate

Age range10 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Nulliparous and multiparous pregnant women * 37 weeks gestation or greater * Living, singleton fetus * No major fetal malformations * Cephalic presentation * No prior uterine scar * Intact fetal membranes * Qualifies for prostaglandin administration according to current Parkland protocol * Have a cervical dilation of 2 centimeters or less, measured at the level of the internal os * Have an indication for induction or attempted induction of labor according to Parkland protocol Exclusion Criteria: * Non-reassuring fetal status * Active herpes outbreak * Prior uterine scar * Contraindication to prostaglandins according to current Parkland protocol (including 4 or more painful contractions per 10 min prior to prostaglandin administration) * Contraindication to vaginal delivery

What they're measuring

Number of Participants with Vaginal Delivery

Timeframe: at delivery

Trial details

NCT IDNCT04755218

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-09-18