Labor Induction With Oral Versus Vaginal Misoprostol

NCT04755218 | Completed DMC

• 1 other identifier: STU 2020-1395
• Study Type: observational
• Target: 2,546
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy; Labor, Induced

Keywords

Pregnancy; Labor induction; Cervical Ripening; misoprostol

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Vaginal Delivery

  vaginal delivery at first induction

  at delivery

Secondary Outcomes (19)

• Time to Delivery

  from start of induction agent to time of delivery

• Time (hours) of Oxytocin

  at delivery

• Need for Oxytocin

  at delivery

• Indication for Cesarean Delivery

  at delivery

• Use of Epidural During Labor

  at delivery

Study Arms (2)

Vaginal Misoprostol

Patients will receive vaginal misoprostol 25 micrograms given every 3 hours for a maximum of 5 doses. Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States

Oral Misoprostol

Patients will receive standard oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses according to current labor induction protocol

Eligibility Criteria

• Age: 10 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Nulliparous and multiparous pregnant women at 37 weeks gestation or greater, with a living, singleton fetus and no major fetal malformations, in cephalic presentation, no prior uterine scar, with intact fetal membranes, who qualify for prostaglandin administration and who have a cervical dilation of 2 centimeters or less, measured at the level of the internal os, requiring induction at Parkland Health and Hospital System.

You may qualify if:

• Nulliparous and multiparous pregnant women
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Health and Hospital Systems

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• Adhikari EH, McGuire J, Lo J, McIntire DD, Spong CY, Nelson DB. Vaginal Compared With Oral Misoprostol Induction at Term: A Cluster Randomized Controlled Trial. Obstet Gynecol. 2024 Feb 1;143(2):256-264. doi: 10.1097/AOG.0000000000005464. Epub 2023 Nov 21.

  PMID: 37989142 DERIVED

Study Officials

• Emily H Adhikari, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 16, 2021
• Study Start: May 24, 2021
• Primary Completion: September 18, 2022
• Study Completion: July 7, 2023
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)