Foley Bulb With Oral Misoprostol for Induction of Labor

NCT03407625 | Completed Results DMC

• 1 other identifier: STU 092016-026
• Study Type: interventional
• Target: 2,227
• Locations: 1 country
• Sites: 1

Brief Summary

Induction of labor is associated with increased cesarean delivery rates, particularly in women with an unfavorable cervix. Both pharmacologic and mechanical methods are utilized for cervical ripening and labor induction. Evidence on the safety and effectiveness of various mechanical and pharmacologic methods of cervical ripening and labor induction is abundant, and yet the majority of clinical trials evaluate time to delivery, rather than mode of delivery. This is a prospective, cluster-randomized clinical trial to compare a standard method of induction at our institution (oral misoprostol) with an alternative, commonly used combination method of oral misoprostol and transcervical foley bulb in women with term pregnancies requiring induction of labor.

Conditions

Pregnancy; Labor, Induced

Keywords

Pregnancy; Labor Induction; Cervical Ripening

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Vaginal Delivery

  vaginal delivery at first induction

  at delivery

Secondary Outcomes (23)

• Time to Delivery

  from start of induction agent to time of delivery

• Indication for Cesarean Delivery

  at delivery

• Dose of Oxytocin Given (mcg or mg)

  at delivery

• Time With Foley Bulb in Place

  From time of documented insertion until the time of documented expulsion or removal, whichever came first, assessed up to 24 hours.

• Presence of Chorioamnionitis

  at delivery

Study Arms (2)

Foley bulb plus Oral Misoprostol

EXPERIMENTAL

Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses.

Other: Foley bulb plus Oral Misoprostol

Oral Misoprostol

ACTIVE COMPARATOR

Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses.

Other: Oral Misoprostol

Interventions

Foley bulb plus Oral Misoprostol OTHER

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.

Foley bulb plus Oral Misoprostol

Oral Misoprostol OTHER

Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.

Oral Misoprostol

Eligibility Criteria

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

You may qualify if:

• 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:

• latex allergy
• non-reassuring fetal status
• HIV
• active herpes outbreak
• Prior uterine scar
• Contraindication to prostaglandins according to current Parkland protocol
• 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, Nelson DB, McIntire DD, Leveno KJ. Foley Bulb Added to an Oral Misoprostol Induction Protocol: A Cluster Randomized Trial. Obstet Gynecol. 2020 Nov;136(5):953-961. doi: 10.1097/AOG.0000000000004123.

  PMID: 33030881 DERIVED

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Limitations and Caveats

Pre-specified outcomes (dose of Oxytocin give at the delivery, terbutaline use, and the number of participants with intravenous analgesia during labor) were not collected as they were found to be not meaningful.

Results Point of Contact

• Title: Emily Adhikari, MD
• Organization: University of Texas Southwestern Medical Center

emily.adhikari@utsouthwestern.edu

214-648-7825

Study Officials

• Emily H Adhikari, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Cluster randomized trial

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 23, 2018
• Study Start: January 1, 2018
• Primary Completion: May 13, 2019
• Study Completion: May 13, 2019
• Last Updated: November 4, 2020
• Results First Posted: November 4, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)