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A Prospective Comparative Study of Induction of Labor With a Cervical Ripening Double Balloon vs Foley Catheter

NCT ID: NCT00501033

Last Updated: 2008-05-08

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-05-31

Brief Summary

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Hypothesis: The induction of labor in patients with unfavorable Bishop score is a challenging obstetrical process, and may be influenced or complicated by the cervical ripening method used. We will conduct a comparative study of the foley catheter vs the cervical ripening double balloon (Cook medical, GPN: G48149). We will compare the failure rates, cesarean section rate, infections and postpartum complications, especially endometritis.

Detailed Description

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We will conduct a comparative study of the foley catheter vs the cervical ripening double balloon (Cook medical, GPN: G48149). We will compare the failure rates, cesarean section rate, infections and postpartum complications, especially endometritis. The study will include 200 parturients, 100 primiparous and 100 multiparous women. We will randomize each group to induction with the foley catheter or the cervical ripening double balloon. We will compare the failure rates, cesarean section rate, infectious and other postpartum complications, especially endometritis.

Conditions

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Induction of Labor Cesarean Endometritis

Keywords

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Induction of labor Cesarean Endometritis Foley Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Mechanical induction of labor

Intervention Type DEVICE

Double Balloon

Intervention Type DEVICE

Foley Catheter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Term pregnancy
* Parturients candidates for mechanical induction of labor

Exclusion Criteria

* Suspected amnionitis
* Vaginal discharge
* Pre induction pyrexia
* Immunocompromised parturients
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Western Galilee Hospital-Nahariya

OTHER_GOV

Sponsor Role lead

Responsible Party

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Western Galilee Hospital

Principal Investigators

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Ido Solt, MD

Role: PRINCIPAL_INVESTIGATOR

Western Galilee Hospital

Locations

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Western Galilee Hospital

Nahariya, , Israel

Site Status

Countries

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Israel

References

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Solt I, Frank Wolf M, Ben-Haroush S, Kaminskyi S, Ophir E, Bornstein J. Foley catheter versus cervical double balloon for labor induction: a prospective randomized study. J Matern Fetal Neonatal Med. 2021 Apr;34(7):1034-1041. doi: 10.1080/14767058.2019.1623776. Epub 2019 Jun 11.

Reference Type DERIVED
PMID: 31185762 (View on PubMed)

Other Identifiers

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4

Identifier Type: -

Identifier Source: org_study_id