NCT00501033

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable

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

January 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

May 8, 2008

Status Verified

May 1, 2008

Enrollment Period

2.1 years

First QC Date

July 12, 2007

Last Update Submit

May 2, 2008

Conditions

Induction of LaborCesareanEndometritis

Keywords

Induction of laborCesareanEndometritisFoleyInfections

Outcome Measures

Primary Outcomes (1)

  • Success of labor induction

    Postpartum period

Secondary Outcomes (2)

  • Postpartum endometritis rate

    The postpartum period

  • Cesarean section rate

    Delivery

Interventions

Mechanical induction of laborDEVICE
Double BalloonDEVICE
Foley CatheterDEVICE

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Term pregnancy
  • Parturients candidates for mechanical induction of labor

You may not qualify if:

  • Suspected amnionitis
  • Vaginal discharge
  • Pre induction pyrexia
  • Immunocompromised parturients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Galilee Hospital

Nahariya, 22100, Israel

Location

Related Publications (1)

  • 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.

    PMID: 31185762DERIVED

MeSH Terms

Conditions

EndometritisInfections

Interventions

Double-Balloon Enteroscopy

Condition Hierarchy (Ancestors)

Pelvic Inflammatory DiseaseAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUterine DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Balloon EnteroscopyEndoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Ido Solt, MD

    Western Galilee Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 12, 2007

First Posted

July 13, 2007

Study Start

January 1, 2006

Primary Completion

February 1, 2008

Study Completion

May 1, 2008

Last Updated

May 8, 2008

Record last verified: 2008-05

Locations

IL(1)