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Foley Bulb With Oral Misoprostol for Induction of Labor

NCT03407625 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2227

Last updated 2020-11-04

Study results available
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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

Interventions

OTHER

Foley bulb plus Oral Misoprostol

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.

OTHER

Oral Misoprostol

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

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Emily H Adhikari, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2019-05-13
Completion
2019-05-13

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03407625 on ClinicalTrials.gov