NCT05798728

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 9, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

April 5, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

March 7, 2023

Last Update Submit

March 22, 2023

Conditions

Induced Vaginal DeliveryInduced; Birth

Keywords

MisoprostolCytotecCervical ripeningOutpatientInpatientTranscervical foley balloonMechanical dilation

Outcome Measures

Primary Outcomes (1)

  • Time from hospital admission to delivery of the newborn

    The primary outcome is to determine if there is a difference in the time from admission to delivery for those who receive transcervical foley balloon in the clinic the day before induction compared to those who get vaginal misoprostol in the hospital on the day of the induction

    From hospital admission until delivery of the newborn

Secondary Outcomes (18)

  • Chorioamnionitis/endometritis

    From hospital admission until 2 weeks postpartum

  • Cesarean delivery

    From hospital admission until delivery of the newborn

  • Postpartum hemorrhage

    From hospital admission until 2 weeks postpartum

  • Delivery within 24 hours of hospital admission

    From hospital admission until delivery of the newborn

  • Total hospital length of stay

    From hospital admission until discharge, assessed up to a week

  • +13 more secondary outcomes

Study Arms (2)

Inpatient Vaginal Misoprostol

ACTIVE COMPARATOR

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

Procedure: Inpatient Vaginal Misoprostol

Outpatient transcervical foley balloon

EXPERIMENTAL

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.

Procedure: Outpatient transcervical foley balloon

Interventions

Outpatient transcervical foley balloonPROCEDURE

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.

Outpatient transcervical foley balloon
Inpatient Vaginal MisoprostolPROCEDURE

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.

Inpatient Vaginal Misoprostol

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Term singleton pregnancy (37 weeks of gestation or greater)
  • Bishop score less than 6 and a maximum cervical dilation of 2 cm
  • Cephalic presentation

You may not qualify if:

  • Rupture of membranes
  • Regular uterine contractions (3 or more contractions per 10 minutes)
  • History of prior uterine surgery (cesarean delivery or myomectomy)
  • Multiples gestations
  • Malpresentation
  • Nonreassuring fetal heart tracing (category 3 or persistent category 2)
  • Fetal demise
  • Anomalous fetus
  • Any contraindication to vaginal delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hurley Medical Center

Flint, Michigan, 48503, United States

RECRUITING

Study Officials

  • Atinuke Akinpeloye, MD

    Hurley Medical Canter

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Barouyr Ajemian, MD

CONTACT

810-262-6862bajemia1@hurleymc.com

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
Core faculty in the department of Obstetrics and Gynecology

Study Record Dates

First Submitted

March 7, 2023

First Posted

April 5, 2023

Study Start

June 9, 2022

Primary Completion

June 9, 2023

Study Completion

October 1, 2023

Last Updated

April 5, 2023

Record last verified: 2023-03

Locations

US(1)