Outpatient Transcervical Balloon For Induction of Labor

Hurley Medical Center

Status: Enrolling

Conditions: Induced; Birth; Induced Vaginal Delivery

Treatments: Procedure: Inpatient Vaginal Misoprostol; Procedure: Outpatient transcervical foley balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT05798728

1914347

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Inpatient Vaginal Misoprostol

Active Comparator group

Description:

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

Treatment:

Procedure: Inpatient Vaginal Misoprostol

Outpatient transcervical foley balloon

Experimental group

Description:

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.

Treatment:

Procedure: Outpatient transcervical foley balloon