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Outpatient Transcervical Balloon For Induction of Labor

NCT05798728 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-04-05

No results posted yet for this study

Summary

The goal of this randomized control trial is to compare outpatient transcervical foley balloon to inpatient vaginal misoprostol in pregnant women for cervical ripening. The main questions it aims to answer are:

1. Does outpatient transcervical foley balloon decreased the time from admission to delivery compared to inpatient vaginal misoprostol
2. Does outpatient transcervical foley balloon will increase risk of c-section during induction of labor compared to inpatient vaginal misoprostol

Participants will be randomized to either the outpatient transcervical foley balloon group or to the inpatient intravaginal misoprostol group. The researchers will compare if outpatient transcervical foley balloon decreases the tie from hospital admission to delivery of the baby.

Conditions

  • Induced Vaginal Delivery
  • Induced; Birth

Interventions

PROCEDURE

Outpatient transcervical foley balloon

These participants will receive a 16-French Foley catheter which will be placed by a physician present in the clinic. The balloon will be inflated with 40 mL of sterile water, and the catheter will then be gently withdrawn so that the balloon applies pressure against the internal os. The catheter will then be taped to the inner thigh.

PROCEDURE

Inpatient Vaginal Misoprostol

These participants will receive 25 micrograms of Misoprostol (100- microgram tablet cut into fourths by the hospital pharmacist) inserted vaginally into the posterior fornix every 4 hours and repeated up to a maximum of six doses per our standard hospital protocol.

Sponsors & Collaborators

  • Hurley Medical Center

    lead OTHER

Principal Investigators

  • Atinuke Akinpeloye, MD · Hurley Medical Canter

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-09
Primary Completion
2023-06-09
Completion
2023-10-01

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 NCT05798728 on ClinicalTrials.gov