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Trial of Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction

NCT ID: NCT00442663

Last Updated: 2007-04-24

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2005-12-31

Brief Summary

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The purpose of this study is to compare the efficacy of a transcervical Foley catheter with and without extra-amniotic saline infusion (EASI) for priming the cervix for labor.

Detailed Description

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In the United States, labor inductions have increased from 11% of all pregnancies in 1989 to 21% in 2004. Although the indications for labor induction vary, labor inductions as an obstetrical practice are associated with an increased risk of Cesarean delivery. As such, the rise in labor inductions has been paralleled by a rise in the cesarean rate to an all time high of 30%. The risk of cesarean can be mitigated with the use of cervical ripening agents in the setting of an unfavorable cervix. Both pharmacological ripening agents and mechanical methods are currently available for cervical priming. Methods available for mechanical dilation include, but are not limited to transcervical foley catheter alone and transcervical foley catheter with an extra-amniotic saline infusion or EASI. The potential advantage of EASI to transcervical foley catheter alone is the promotion of endogenous prostaglandin release by membrane stripping and supplying additional mechanical force. It may be disadvantageous by increasing the risk of chorioamnionitis or by diluting the prostaglandins that are released by membrane stripping. There have been two randomized trials comparing foley alone to foley with EASI. Because the results of these two trials are conflicting, we chose to conduct a randomized clinical trial of foley catheter compared to foley catheter with an EASI for labor induction and cervical ripening in women with an unfavorable cervix.

Conditions

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Labor Induction Cervical Ripening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Transcervical Foley Catheter

Intervention Type DEVICE

Transcervical Foley Catheter with an EASI

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Singleton pregnancy
* 24-42 weeks of gestation
* Cephalic presentation
* Intact membranes
* Bishop score of less than or equal to 6

Exclusion Criteria

* Contraindications to labor
* Dead or severely anomalous fetus
* Spontaneous labor.
Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Principal Investigators

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Monique G Lin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

George Lu, MD

Role: PRINCIPAL_INVESTIGATOR

Obstetrix Medical Group of Kansas City

Patrick S Ramsey, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Truman Medical Center

Kansas City, Kansas, United States

Site Status

Saint Luke's Hospital

Kansas City, Kansas, United States

Site Status

Greenville Hospital System, University Medical Center

Greenville, South Carolina, United States

Site Status

Countries

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United States

References

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Guinn DA, Davies JK, Jones RO, Sullivan L, Wolf D. Labor induction in women with an unfavorable Bishop score: randomized controlled trial of intrauterine Foley catheter with concurrent oxytocin infusion versus Foley catheter with extra-amniotic saline infusion with concurrent oxytocin infusion. Am J Obstet Gynecol. 2004 Jul;191(1):225-9. doi: 10.1016/j.ajog.2003.12.039.

Reference Type BACKGROUND
PMID: 15295370 (View on PubMed)

Karjane NW, Brock EL, Walsh SW. Induction of labor using a foley balloon, with and without extra-amniotic saline infusion. Obstet Gynecol. 2006 Feb;107(2 Pt 1):234-9. doi: 10.1097/01.AOG.0000198629.44186.c8.

Reference Type BACKGROUND
PMID: 16449106 (View on PubMed)

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)

Lin MG, Reid KJ, Treaster MR, Nuthalapaty FS, Ramsey PS, Lu GC. Transcervical Foley catheter with and without extraamniotic saline infusion for labor induction: a randomized controlled trial. Obstet Gynecol. 2007 Sep;110(3):558-65. doi: 10.1097/01.AOG.0000278077.30890.87.

Reference Type DERIVED
PMID: 17766600 (View on PubMed)

Other Identifiers

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F050629003

Identifier Type: -

Identifier Source: org_study_id