Outpatient Transcervical Balloon For Induction of Labor

NCT ID: NCT05798728

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-09
• Study Completion Date: 2023-10-01

Brief 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.

Detailed Description

This is a prospective randomized unblinded control trial. Consented patients will have a cervical exam performed in the clinic to confirm that the bishop score is less than 6. Once this and the inclusion criteria are met, the participant will be randomized to either the outpatient transcervical foley arm or the vaginal misoprostol arm. Each pregnant woman will undergo the intervention stated in the numbered envelope which will be distributed based on their order of inclusion in the study. Due to the nature of the procedure, blinding could not be done.

Participants randomized to the transcervical foley group will be scheduled an appointment in the clinic the day before their scheduled induction day for the final screen and foley placement. On the other hand, participants randomized to the vaginal misoprostol group will be admitted to the labor and delivery unit on the day of their scheduled induction. All participants will undergo a cervical examination before the assigned intervention to verify their eligibility status. Those who do not meet the eligibility criteria, will be excluded. Both transcervical foley and vaginal misoprostol are standard of care for induction of labor at Hurley Medical Center. Thus, there would be no additional cost to the patient. The only difference in the study is the setting in which the transcervical foley is placed, i.e. in the obstetrics clinic as an outpatient.

Oxytocin will be initiated in all patients who did not have at least three regular contractions in 10 minutes. Continuous fetal heart rate monitoring and uterine activity monitoring will be performed in all patients. Amniotomy will be performed during the course of labor at the discretion of the health care provider and epidural anesthesia will be administered per the patient's request.

Conditions

Induced Vaginal Delivery; Induced; Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Inpatient Vaginal Misoprostol

These participants will receive intravaginal Misoprostol in the inpatient setting per our standard hospital protocol for cervical ripening.

Group Type: ACTIVE_COMPARATOR

Inpatient Vaginal Misoprostol

Intervention Type: PROCEDURE

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.

Outpatient transcervical foley balloon

These participants will receive a catheter which will be placed by a physician present in the clinic, however, patient are discharged home for 12 hours until their time of induction of labor.

Group Type: EXPERIMENTAL

Outpatient transcervical foley balloon

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Term singleton pregnancy (37 weeks of gestation or greater)

2. Bishop score less than 6 and a maximum cervical dilation of 2 cm

3. Cephalic presentation

Exclusion Criteria

1. Rupture of membranes

2. Regular uterine contractions (3 or more contractions per 10 minutes)

3. History of prior uterine surgery (cesarean delivery or myomectomy)

4. Multiples gestations

5. Malpresentation

6. Nonreassuring fetal heart tracing (category 3 or persistent category 2)

7. Fetal demise

8. Anomalous fetus

9. Any contraindication to vaginal delivery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hurley Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Atinuke Akinpeloye

Core faculty in the department of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Atinuke Akinpeloye, MD

Role: PRINCIPAL_INVESTIGATOR

Hurley Medical Canter

Locations

Hurley Medical Center

Flint, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Barouyr Ajemian, MD

Role: CONTACT

bajemia1@hurleymc.com

810-262-6862

Facility Contacts

Barouyr Ajemian, MD

Role: primary

bajemia1@hurleymc.com

Other Identifiers

1914347

Identifier Type: -

Identifier Source: org_study_id