Foley Bulb With Oral Misoprostol for Induction of Labor

NCT ID: NCT03407625

Last Updated: 2020-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2227 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-05-13

Brief Summary

Induction of labor is associated with increased cesarean delivery rates, particularly in women with an unfavorable cervix. Both pharmacologic and mechanical methods are utilized for cervical ripening and labor induction. Evidence on the safety and effectiveness of various mechanical and pharmacologic methods of cervical ripening and labor induction is abundant, and yet the majority of clinical trials evaluate time to delivery, rather than mode of delivery. This is a prospective, cluster-randomized clinical trial to compare a standard method of induction at our institution (oral misoprostol) with an alternative, commonly used combination method of oral misoprostol and transcervical foley bulb in women with term pregnancies requiring induction of labor.

Detailed Description

The purpose of this study is to determine whether the use of a transcervical foley catheter, in combination with the standard oral misoprostol regimen will result in a decreased primary cesarean delivery rate among women with a cervical dilation of 2 centimeters of less who require induction of labor at term. This study is not an FDA-regulated study: there is no intent to test the foley bulb under an FDA-regulated protocol. Likewise, there is no intent to submit the results of this study for a change in the labeling of the foley used for this study. This study was approved by the Institutional Review Board of the University of Texas Southwestern Medical Center, and by the Office of Research Administration at Parkland Health and Hospital System.

This will be a prospective, cluster-randomized trial comparing two accepted methods of induction of labor at term among women who present for delivery at Parkland Hospital. Eligible participants will include nulliparous and multiparous women at 37 weeks gestation or greater, with a living, singleton fetus and no major fetal malformations, in cephalic presentation, with intact membranes, no prior uterine scar, who qualify for prostaglandin administration and who have a cervical dilation of 2 centimeters or less, measured at the level of the internal os. Patients with latex allergy, non-reassuring fetal status, HIV, active herpes outbreak, a prior uterine scar, or any contraindication to prostaglandins (including 4 or more painful contractions per 10 minutes prior to prostaglandin administration) will be excluded from participation in the study.

Computer-generated cluster randomization will occur on a weekly basis for all study participants, to either the combination method of foley bulb plus oral misoprostol regimen (study group) or to oral misoprostol alone regimen (control).

According to the randomization protocol each week, participants will be randomized to either the standard of care (oral misoprostol/control group) or standard of care plus foley bulb (study group). The study group will undergo placement of a 30 French foley catheter filled with 30-35cc sterile saline into the cervix in addition to the standard regimen of oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses, for patients who meet criteria for fetal well-being, and do not had more than 4 painful contractions in 10 minutes. Misoprostol will not be administered to patients who have progressed to active labor, defined as 4 centimeters cervical dilation. The control group will undergo induction with our current standard oral misoprostol protocol alone, administered as 100 micrograms given every 4 hours for a maximum of 2 doses. Both groups will receive oxytocin as indicated by current labor protocols at our institution.

The primary outcome will be the rate of vaginal delivery. Secondary outcomes will include obstetric outcomes, maternal outcomes, and neonatal outcomes. Obstetric outcomes will include indication for induction, need for oxytocin, indication for cesarean delivery, time to active labor, time to delivery, labor analgesia, presence of chorioamnionitis, meconium-stained amniotic fluid, terbutaline use, tachysystole (defined as 6 or more contractions in 10 minutes or tetanic contraction of 120 seconds or longer) or hyperstimulation syndrome (defined as tachysystole accompanied by fetal heart rate decelerations). Maternal outcomes will include estimated blood loss, transfusion requirement, postpartum fever, uterine rupture, and unplanned hysterectomy. Neonatal outcomes will include umbilical cord blood pH, 5-minute APGAR score, intubation or ventilation in the delivery room, neonatal sepsis, and admission to Neonatal Intensive Care Unit (NICU) admission.

Conditions

Pregnancy; Labor, Induced

Study Design

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

Study Groups

Foley bulb plus Oral Misoprostol

Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses.

Group Type: EXPERIMENTAL

Foley bulb plus Oral Misoprostol

Intervention Type: OTHER

Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.

Oral Misoprostol

Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses.

Group Type: ACTIVE_COMPARATOR

Oral Misoprostol

Intervention Type: OTHER

Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.

Interventions

Foley bulb plus Oral Misoprostol

Although labeled "experimental" for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States.

Intervention Type: OTHER

Oral Misoprostol

Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 37 weeks gestation or greater
• Living, singleton fetus
• No major fetal malformations
• Cephalic presentation
• No prior uterine scar
• Intact fetal membranes
• Qualifies for prostaglandin administration according to current Parkland protocol
• Have a cervical dilation of 2 centimeters or less, measured at the level of the internal os
• Have an indication for induction or attempted induction of labor according to Parkland protocol

Exclusion Criteria

• latex allergy
• non-reassuring fetal status
• HIV
• active herpes outbreak
• Prior uterine scar
• Contraindication to prostaglandins according to current Parkland protocol
• Contraindication to vaginal delivery

• Minimum Eligible Age: 10 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Emily Adhikari

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emily H Adhikari, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

Parkland Health and Hospital Systems

Dallas, Texas, United States

Countries

United States

References

Adhikari EH, Nelson DB, McIntire DD, Leveno KJ. Foley Bulb Added to an Oral Misoprostol Induction Protocol: A Cluster Randomized Trial. Obstet Gynecol. 2020 Nov;136(5):953-961. doi: 10.1097/AOG.0000000000004123.

Reference Type: DERIVED

PMID: 33030881 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STU 092016-026

Identifier Type: -

Identifier Source: org_study_id