Outpatient Transcervical Balloon For Induction of Labor

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05798728
Study type	Interventional
Source	Hurley Medical Center
Contact	Barouyr Ajemian, MD
Phone	810-262-6862
Email	bajemia1@hurleymc.com
Status	Recruiting
Phase	N/A
Start date	June 9, 2022
Completion date	October 1, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03730220` - The Norwegian Induction Project: a Pilot for a Prospective National Audit
Completed	`NCT05100264` - Effect of Acidic Vaginal pH on the Efficacy of Dinoprostone for Labor Induction	N/A
Completed	`NCT05037617` - The REDUCED-I Pilot Trial: REDucing the Utilization of CEsarean Sections With Induction	N/A
Recruiting	`NCT06272591` - Comparison of Patient Satisfaction With Home Induction and In-patient Induction.
Completed	`NCT03670836` - Comparison of Misoprostol Ripening Efficacy With Dilapan	Phase 4
Completed	`NCT04017247` - Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor	N/A
Completed	`NCT05062343` - Cook Balloon vs Dilapan-S for Outpatient Cervical Ripening	N/A
Completed	`NCT02788305` - Effect of Maternal Obesity on Labour Induction in Postdate Pregnancy	N/A
Terminated	`NCT04004845` - Labor Protocol Study
Recruiting	`NCT06053073` - Induction to Labour With Double Cervical Ballon at Home Versus at Hospital	N/A
Completed	`NCT04645823` - Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor	Phase 4
Completed	`NCT04746248` - Outpatient Labor Induction Using Oral Misoprostol in Norway	N/A
Recruiting	`NCT05671224` - Visual Aids for Induction of Labor RCT	N/A
Completed	`NCT04756089` - Stimulation Therapy for Inducing Mothers	N/A
Withdrawn	`NCT04739683` - Cervical Ripening With Foley Bulb Versus Dilapan-S at Home	N/A
Not yet recruiting	`NCT04307199` - Membrane Sweeping to Prevent Post-term Pregnancy: The MILO Study	N/A
Completed	`NCT03725397` - Inpatient Versus Outpatient Foley Cervical Ripening Study	N/A
Recruiting	`NCT05719467` - SAINT: Safe Induction of Labor Trial	Phase 3
Completed	`NCT03113227` - Value of Measuring Cervical Angle and Length by Ultrasound in Prediction of Successful Induction of Delivery	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.