NCT00451308

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

August 2, 2013

Status Verified

July 1, 2013

Enrollment Period

2.7 years

First QC Date

March 22, 2007

Last Update Submit

July 31, 2013

Conditions

Induction of Labor

Keywords

Induction of laborvaginal deliverycesarean sectionfoley balloon cathethermethod of labor inductionperinatal outcomes

Outcome Measures

Primary Outcomes (1)

  • Rate of vaginal delivery within 24 hours

    within 24 hours

Secondary Outcomes (15)

  • Cervical dilation after Foley balloon catheter expulsion

    within 24hours

  • Time to catheter expulsion

    hours

  • Duration of the first stage of labor

    hours

  • Time interval from induction to active labor

    hours

  • Induction to delivery interval

    hours

  • +10 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Foley balloon wih 60cc fluid

Procedure: Induction of labor with foley balloon - 60cc of saline

2

ACTIVE COMPARATOR

Foley balloon with 30cc

Procedure: Induction of labor with foley balloon with 30cc

Interventions

Induction of labor with foley balloon - 60cc of salinePROCEDURE

60 cc of fluid

1
Induction of labor with foley balloon with 30ccPROCEDURE

30cc of saline in foley

2

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

San Francisco, California, 94143, United States

Location

Related Publications (2)

  • 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.

    PMID: 36996264DERIVED

  • 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.

    PMID: 20502296DERIVED

MeSH Terms

Interventions

Labor, Induced

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Aaron B Caughey, MD,PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2007

First Posted

March 23, 2007

Study Start

November 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

August 2, 2013

Record last verified: 2013-07

Locations

US(1)