Foley Labor Induction Trial at Term and in PROM

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-04-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is considering current standard oxytocin dosing regimen in combination with Foley bulb for cervical ripening is associated with improved outcomes including greater percentage of women delivered within or less than 24 hours. The investigators will also assess other maternal and neonatal outcomes including risk of infection (i.e. chorioamnionitis), bleeding, uterine atony, cesarean delivery and use of regional analgesia.

Participants will be randomly assigned to one of the 2 arms of the study: use of oxytocin or no oxytocin while the Foley bulb is in place. As part of standard of care for inductions, Foley bulbs will be placed for all participants. Study participants who are randomly assigned to the use of oxytocin will receive oxytocin at the time the Foley bulb is placed. Study participants randomly assigned to no oxytocin will receive the oxytocin once the Foley bulb is removed.

After delivery, information will be collected from participant's chart on the outcome of pregnancy such as gestational age at delivery, type of delivery (vaginal or cesarean section), and baby's outcome (such as birth weight, APGAR scores, and any complications).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Foley Bulb With Low Dose Pitocin Versus Foley Bulb With a Standard Incremental Infusion Protocol for the Induction of Labor

NCT02150954

Induction of Labor

COMPLETED PHASE4

Outpatient Labor Induction With the Transcervical Foley Balloon

NCT02210598

Pregnancy Labor; Forced or Induced, Affecting Fetus or Newborn

UNKNOWN NA

Foley Bulb With Oral Misoprostol for Induction of Labor

NCT03407625

Pregnancy Labor, Induced

COMPLETED NA

Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor

NCT00684606

Pregnancy Induction of Labor

UNKNOWN NA

Adjuvant Oxytocin for Preinduction Ripening With a Foley catheter--a Clinical Trial

NCT00468520

Pregnancy Induced Labor Cervical Ripening

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Currently there is a paucity of literature to determine the efficacy of use of Pitocin during Foley placement, a single study has been published which suggests that the induction to delivery time is shortened in multiparas, but not in nulliparas. This study was not specifically powered to assess nulliparas as well, without increased risk.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Induction of Labor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

No oxytocin while the Foley bulb is in place

Group Type NO_INTERVENTION

No interventions assigned to this group

Oxytocin

Use of oxytocin while the Foley bulb is in place

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

Use of oxytocin while the Foley bulb is in place

PROMS Foley and oxytocin

Subjects who are induced due to premature rupture of membranes randomized to use of Foley bulb and oxytocin once the bulb is removed.

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

Use of oxytocin while the Foley bulb is in place

PROMS no Foley bulb

Subjects who are induced due to premature rupture of membranes randomized to no Foley bulb.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oxytocin

Use of oxytocin while the Foley bulb is in place

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Pitocin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* women at \> 24 weeks gestation
* a non-anomalous, singleton fetus in a vertex presentation

Exclusion Criteria

* history of prior uterine surgery such as cesarean section or myomectomy
* unexplained vaginal bleeding
* latex allergy
* contraindication to vaginal delivery (i.e. placenta previa, vasa previa, active vaginal bleeding, macrosomia etc)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes