NCT01402050

Brief Summary

OBJECTIVE: To assess the efficacy of transcervical Foley catheter compared to controlled release prostaglandin (Cervidil™) for cervical ripening in term and near term women presenting for labor induction. HYPOTHESIS: In term and near term women presenting for labor induction, transcervical Foley catheter will decrease the mean time from induction to delivery by six hours compared to controlled release prostaglandin (Cervidil™).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
376

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

June 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
5 years until next milestone

Results Posted

Study results publicly available

February 6, 2020

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

4.4 years

First QC Date

April 8, 2011

Results QC Date

January 24, 2020

Last Update Submit

February 18, 2020

Conditions

Labor Induction

Keywords

Time from the start of the induction to delivery

Outcome Measures

Primary Outcomes (1)

  • Time Of Start Of Induction Of Labor To Delivery

    The primary outcome variable was time (measured in hours) from first attempt at study agent placement to delivery. Time of placement of Labor Induction agent was noted as the time of Labor Induction initiation and time of delivery was noted as the end time of Labor Induction. There were no specific time points at which the outcomes were measured due to the uncertainty of the labor process. Total time duration of Labor induction was noted in hours. Key word: INDUCTION OF LABOR

    Hours

Study Arms (2)

FOLEY BALLOON

ACTIVE COMPARATOR

Comparing foley balloon to cervidil for decreased time from the start of the induction process to delivery

Device: FOLEY BALLOON

CERVIDIL

ACTIVE COMPARATOR
Drug: CERVIDIL (Dinoprostone)

Interventions

CERVIDIL (Dinoprostone)DRUG

INDUCTION OF LABOR

CERVIDIL
FOLEY BALLOONDEVICE

INDUCTION OF LABOR

FOLEY BALLOON

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Cervix \< 3 cm dilated. If 2cm dilated, must be \< 80% effaced.
  • Gestational age ≥ 36 weeks by best obstetric estimate, and clinical management decision is delivery.
  • Singleton gestation
  • Cephalic presentation

You may not qualify if:

  • Regular uterine contractions (more frequent than every 5 minutes)
  • PROM
  • Prior transverse uterine incision or any obstetric contraindication to labor
  • Fever (defined as a temperature of 38°C or higher)
  • Lethal fetal anomalies (Labor induction is being performed, but there is no plan for fetal heart rate monitoring or cesarean delivery for fetal indications.)
  • Fetal death
  • Placenta previa
  • Suspected placental abruption or undiagnosed bleeding characterized as more than "spotting"
  • Non-reassuring fetal heart rate pattern
  • HIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Banner Desert Medical Center

Mesa, Arizona, 85210, United States

Location

Banner Good Samaritan Medical Center

Phoenix, Arizona, 85006, 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

  • Edwards RK, Szychowski JM, Berger JL, Petersen M, Ingersoll M, Bodea-Braescu AV, Lin MG. Foley catheter compared with the controlled-release dinoprostone insert: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1280-1287. doi: 10.1097/AOG.0000000000000238.

    PMID: 24807327DERIVED

MeSH Terms

Interventions

Dinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Results Point of Contact

Title
Ana Braescu
Organization
Phoenix Perinatal Associates - Mednax
ana_braescu@mednax.com
602-614-0488

Study Officials

  • Monique G Lin, MD

    Obstetrix Medical Group

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

April 8, 2011

First Posted

July 26, 2011

Study Start

June 1, 2010

Primary Completion

November 1, 2014

Study Completion

February 1, 2015

Last Updated

March 2, 2020

Results First Posted

February 6, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)