MedDataX Logo

Induction of Labor With a Foley Balloon Catheter: Inflation With 30ml Compared to 60ml

NCT ID: NCT00451308

Last Updated: 2013-08-02

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

PHASE4

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-07-31

Brief Summary

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

The rate of labor induction is rising throughout the United States for a variety of reasons. Medical conditions that lead to increased risk of prolonging the pregnancy to both mother and fetus are not infrequent. In addition, elective deliveries are becoming more common. Foley balloon catheter placement is a common method used for labor induction in women with an unfavorable cervical assessment. There are several studies using various volumes of Foley balloon catheters for labor induction ranging from 30ml to 80ml, however, there are no studies replicating the findings of the largest study comparing 2 different volumes in the balloon. The investigators plan to compare instillation of 30ml of sterile saline versus 60ml in a Foley balloon catheter for women undergoing induction of labor with an unfavorable cervix. The investigators will observe the following outcomes: rate of delivery within 24 hours, cervical dilation after foley balloon catheter expulsion, insertion to balloon expulsion interval, induction to delivery time interval, peak oxytocin requirement, presence of infection or meconium, cesarean delivery rate, operative vaginal delivery rate, indication for operative vaginal or cesarean delivery, cervical laceration rate, placental abruption rate, 5-minute Apgar score, and umbilical cord arterial blood pH and base excess.

Detailed Description

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

All potential candidates will be approached for the study and undergo written consent if willing to participate. Each candidate will be randomized to 30ml or 60 ml Foley balloon catheter volume. A random number generator will be used and within a sealed envelope will be placed the assignment. Nulliparous and multiparous patients will be randomized separately. The patient will be positioned for a standard cervical exam - either for digital or speculum exam, depending on the individual patient preference and provider choice. For digital exam, a sterile Foley balloon catheter will be digitally placed in the endocervical canal, into the extraamniotic space (between the fetal head, external to the unruptured amniotic sac, above the internal os of the cervix). For speculum exam, the cervix is wiped three times with a Betadine cleansing solution, and a sterile Foley balloon catheter bulb will be placed under direct visualization into the endocervical canal, into the extraamniotic space. Once the balloon is in place the provider inserts 30ml of sterile saline. The provider then leaves the room. The patient's nurse opens the envelope and if the patient is allocated to the 60ml volume group, the nurse adds an additional 30ml of sterile saline. If the patient is in the 30ml group, the RN staff will simulate placement of additional saline into the foley balloon without actually placing any additional saline in order to also blind the patients to their assigned group. The MD/CNM providers will then return to the room, blinded to the inflation of the Foley balloon, and the balloon catheter will be placed under tension by taping the external end to the patient's inner thigh. Oxytocin will be started within 30 minutes of the Foley balloon catheter placement, using the standard intravenous oxytocin protocol. Additional manual traction on the Foley balloon catheter will be performed every 30 minutes until Foley balloon catheter expulsion. A sterile cervical exam will be performed after spontaneous Foley catheter expulsion to evaluate post-balloon cervical dilation. No further procedures or tests specific to this study will be required beyond this point; only data collection on the above study outcomes during the remaining course of the patient's labor will be recorded.

Conditions

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

Induction of Labor

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Induction of labor vaginal delivery cesarean section foley balloon cathether method of labor induction perinatal outcomes

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

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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

1

Foley balloon wih 60cc fluid

Group Type EXPERIMENTAL

Induction of labor with foley balloon - 60cc of saline

Intervention Type PROCEDURE

60 cc of fluid

2

Foley balloon with 30cc

Group Type ACTIVE_COMPARATOR

Induction of labor with foley balloon with 30cc

Intervention Type PROCEDURE

30cc of saline in foley

Interventions

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

Induction of labor with foley balloon - 60cc of saline

60 cc of fluid

Intervention Type PROCEDURE

Induction of labor with foley balloon with 30cc

30cc of saline in foley

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* Reproductive aged women, pregnant, term gestation (\>37 weeks), undergoing induction of labor, cervical exam acceptable as a candidate for Foley balloon catheter placement (Bishop score \<5), cephalic fetal presentation.

Exclusion Criteria

* Regular contractions on admission, rupture of membranes, previous uterine scar, low-lying placenta (measured \<3cm to internal os), Bishop score \> 5, contraindication to attempt at vaginal birth, non-English/Spanish speaking, unable to give consent.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Aaron B Caughey, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California, San Francisco Department of Obstetrics, Gynecology and Reproductive Sciences

San Francisco, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

Reference Type DERIVED
PMID: 36996264 (View on PubMed)

Delaney S, Shaffer BL, Cheng YW, Vargas J, Sparks TN, Paul K, Caughey AB. Labor induction with a Foley balloon inflated to 30 mL compared with 60 mL: a randomized controlled trial. Obstet Gynecol. 2010 Jun;115(6):1239-1245. doi: 10.1097/AOG.0b013e3181dec6d0.

Reference Type DERIVED
PMID: 20502296 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H4114729401-01

Identifier Type: -

Identifier Source: org_study_id