Outpatient Transcervical Balloon For Induction of Labor

Outpatient Transcervical Balloon: Does it Shorten the Hospital Stay for Induction of Labor? Randomized Control Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Induced; Birth; Induced Vaginal Delivery
• Intervention / Treatment: Procedure: Inpatient Vaginal Misoprostol; Procedure: Outpatient transcervical foley balloon

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Barouyr Ajemian, MD; Phone Number: 810-262-6862; Email: bajemia1@hurleymc.com

Study Locations

• United States
  • Michigan
    • Flint, Michigan, United States, 48503
      • Recruiting
      • Hurley Medical Center
      • Contact: Barouyr Ajemian, MD; Email: bajemia1@hurleymc.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Inpatient Vaginal Misoprostol; These participants will receive intravaginal Misoprostol in the inpatient setting per our standard hospital protocol for cervical ripening.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chorioamnionitis/endometritis	Number of participants with fever, increased white blood cell count or foul smelling discharge in the outpatient transcervical foley group compared to that of in the intravaginal Misoprostol group	From hospital admission until 2 weeks postpartum
Cesarean delivery	Number of participants delivering via cesarean section in the outpatient transcervical foley group compared to that of in the inpatient intravaginal Misoprostol group	From hospital admission until delivery of the newborn
Postpartum hemorrhage	Number of participants with quantified blood loss greater than 1000ml in the outpatient transcervical foley group compared to that of in the inpatient intravaginal Misoprostol group	From hospital admission until 2 weeks postpartum
Delivery within 24 hours of hospital admission	To determine is if the delivery rate within 24 hours from hospital admission in the outpatient transcervical foley group is greater compared to the inpatient intravaginal Misoprostol group	From hospital admission until delivery of the newborn
Total hospital length of stay	To determine is if there is an increase risk of prolonged hospital stay in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group	From hospital admission until discharge, assessed up to a week
Hospital readmission within 30 days of discharge	To determine is if there is an increase risk of hospital readmission within 30 days of discharge in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group	From discharge until 30 days postpartum
Cervical examination at the time of admission	To determine if cervical dilation is more favorable for induction in the outpatient transcervical foley balloon compared to the inpatient intravaginal Misoprostol	Within the first hour of hospital admission
Unscheduled hospital admissions or unscheduled visits to our obstetric triage unit before the time of scheduled admission	To determine if outpatient transcervical foley balloon placement increases the unscheduled hospital admissions or unscheduled visits to our obstetric triage unit before the time of scheduled admission.	From date of outpatient transcervical foley balloon placement until time of scheduled admission, assessed up to 12 hours
Frequency of acetaminophen use after randomization but before hospital admission	To determine if outpatient transcervical foley balloon placement increases the frequency of acetaminophen use after randomization but before hospital admission	From time of outpatient transcervical foley balloon placement until hospital admission, assessed up to 12 hours
Spontaneous rupture of membranes between randomization and hospital admission	To determine if outpatient transcervical foley balloon placement increases spontaneous rupture of membranes between randomization and hospital admission	From time of transcervical foley balloon placement until spontaneous rupture of membranes, assessed up to 12 hours
Duration of oxytocin infusion (in min)	To determine if there is an increase in the duration of oxytocin infusion (in minutes) in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group	From hospital admission until delivery of the newborn
Maximum oxytocin rate infused (in milliunits/min)	To determine if there is an increase in the maximum oxytocin rate infused (in milliunits/min) in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group	From hospital admission until delivery of the newborn
Duration of neuraxial anesthesia use	To determine is if there is an increase in the duration of neuraxial anesthesia use in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group	From hospital admission until delivery of the newborn
Presence of heavy vaginal bleeding before delivery	To determine if outpatient transcervical foley balloon placement increases heavy vaginal bleeding before delivery	From outpatient transcervical foley balloon insertion until delivery of newborn
Meconium-stained amniotic fluid	To determine is if there is an increase in the rate of meconium-stained amniotic fluid in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group	From hospital admission until delivery of the newborn
Time from rupture of membranes to delivery	To determine is if there is an decreases the duration from rupture of membranes to delivery in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group	From time of rupture of membranes until delivery of the newborn
Highest maternal intrapartum temperature	To determine is if there is an increase in maternal intrapartum temperature in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group	From hospital admission until delivery of the newborn
Admission white blood cell count	To determine is if there is an increase in admission white blood cell count in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group	From hospital admission until delivery of the newborn

Collaborators and Investigators

• Sponsor: Hurley Medical Center
• Investigators: Principal Investigator: Atinuke Akinpeloye, MD, Hurley Medical Canter

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2022
• Primary Completion (Anticipated): June 9, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Outpatient; Cervical ripening; Misoprostol; Inpatient; Cytotec; Transcervical foley balloon; Mechanical dilation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: 1914347

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No