---
title: Foley Bulb With Oral Misoprostol for Induction of Labor
nct_id: NCT03407625
overall_status: COMPLETED
phase: NA
sponsor: University of Texas Southwestern Medical Center
study_type: INTERVENTIONAL
primary_condition: Pregnancy
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03407625.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03407625"
ct_last_update_post_date: 2020-11-04
last_seen_at: "2026-05-12T06:48:46.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Foley Bulb With Oral Misoprostol for Induction of Labor

**Official Title:** Foley Bulb With Oral Misoprostol Versus Oral Misoprostol for Induction of Labor: A Cluster Randomized Trial

**NCT ID:** [NCT03407625](https://clinicaltrials.gov/study/NCT03407625)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 2227
- **Lead Sponsor:** University of Texas Southwestern Medical Center
- **Conditions:** Pregnancy, Labor, Induced
- **Start Date:** 2018-01-01
- **Completion Date:** 2019-05-13
- **CT.gov Last Update:** 2020-11-04

## 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.

## Eligibility

- **Minimum age:** 10 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Foley bulb plus Oral Misoprostol** (EXPERIMENTAL) — Patients will received initial transcervical foley bulb, followed by oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses.
- **Oral Misoprostol** (ACTIVE_COMPARATOR) — Patients will receive oral misoprostol 100 micrograms given every 4 hours for a maximum of 2 doses.

## Interventions

- **Foley bulb plus Oral Misoprostol** (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** (OTHER) — Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.

## Primary Outcomes

- **Number of Participants With Vaginal Delivery** _(time frame: at delivery)_ — vaginal delivery at first induction

## Secondary Outcomes

- **Time to Delivery** _(time frame: from start of induction agent to time of delivery)_
- **Indication for Cesarean Delivery** _(time frame: at delivery)_
- **Dose of Oxytocin Given (mcg or mg)** _(time frame: at delivery)_
- **Time With Foley Bulb in Place** _(time frame: From time of documented insertion until the time of documented expulsion or removal, whichever came first, assessed up to 24 hours.)_
- **Presence of Chorioamnionitis** _(time frame: at delivery)_
- **Use of Intravenous Analgesia During Labor** _(time frame: at delivery)_
- **Number of Participants Used Neuraxial Analgesia During Labor** _(time frame: from start of induction to delivery)_
- **Number of Participants Used General Anesthesia for Delivery** _(time frame: at delivery)_
- **Number of Participants With Meconium-stained Amniotic Fluid** _(time frame: At the time of rupture of membranes and at delivery)_
- **Terbutaline Use** _(time frame: at delivery)_
- **Number of Participants With Tachysystole** _(time frame: at delivery)_
- **Number of Participants With Uterine Hyperstimulation Syndrome** _(time frame: at delivery)_
- **Number of Participants With Excess Blood Loss** _(time frame: at delivery)_
- **Number of Participants With Blood Transfusion** _(time frame: at delivery)_
- **Number of Participants With Uterine Rupture** _(time frame: at delivery)_
- **Number of Participants With Unplanned Hysterectomy** _(time frame: at discharge from the hospital following delivery)_
- **Number of Participants With Postpartum Fever** _(time frame: Following delivery and prior to discharge)_
- **Number of Participants With Umbilical Cord Blood pH <7.0** _(time frame: at delivery)_
- **Number of Participants With an 5-minute Apgar Score Less Than 4** _(time frame: 5 minutes after time of birth)_
- **Number of Participants That Needed Mechanical Ventilation in Delivery Room (Yes/No)** _(time frame: at delivery)_
- **Number of Participants Administered Neonatal Antibiotics and/or Neonatal Blood Cultures** _(time frame: From time of birth until the time of discharge or up to 7 days of life, whichever comes first.)_
- **Number of Participants With Neonatal Sepsis** _(time frame: From time of birth until the time of discharge or up to 7 days of life, whichever comes first.)_
- **Number of Participants With NICU Admission Order** _(time frame: From time of birth until the time of discharge or up to 7 days of life, whichever comes first.)_

## Locations (1)

- Parkland Health and Hospital Systems, Dallas, Texas, United States

## Recent Field Changes (last 30 days)

- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.parkland health and hospital systems|dallas|texas|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03407625.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03407625*  
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