NCT01279343

Brief Summary

The purpose of this study is to compare the efficacy of the combination of the supracervical foley bulb and vaginal misoprostol to vaginal misoprostol alone for labor induction. We hypothesize that use of the foley bulb plus vaginal misoprostol will result in shorter induction to delivery time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

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, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

May 1, 2019

Completed
Last Updated

May 3, 2019

Status Verified

May 1, 2019

Enrollment Period

3.2 years

First QC Date

January 6, 2011

Results QC Date

April 9, 2019

Last Update Submit

May 2, 2019

Conditions

Induction of Labor

Keywords

labor inductionfoley bulbmisoprostol

Outcome Measures

Primary Outcomes (1)

  • Time From Start of Labor Induction to Vaginal Delivery

    72 hours

Secondary Outcomes (9)

  • Successful Number of Vaginal and Cesarean Deliveries

    72 hours

  • Number of Participants Experiencing Tachysystole With Deceleration

    72 hours

  • Number of Participants With Post-partum Hemorrhage

    96 hours

  • Chorioamnionitis

    96 hours

  • Neonatal APGAR Scores

    5 minutes

  • +4 more secondary outcomes

Study Arms (2)

Foley Bulb plus Misoprostol

EXPERIMENTAL
Device: Foley bulb

Misoprostol

NO INTERVENTION

Interventions

Foley bulbDEVICE

This is a randomized trial comparing foley bulb with the use of misoprostol versus use of misoprostol alone for cervical ripening and labor induction.

Also known as: cytotec
Foley Bulb plus Misoprostol

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • singleton pregnancy
  • vertex presentation
  • unfavorable cervix(Bishop's score less than or equal to 6)
  • greater than 24 weeks gestation

You may not qualify if:

  • fetal malpresentation
  • multifetal gestation
  • spontaneous labor
  • more than 5 uterine contractions in 10 minutes
  • contraindication to prostaglandins
  • non-reassuring fetal heart rate tracing
  • intrauterine growth restriction
  • anomalous fetus
  • fetal demise
  • previous cesarean delivery or other significant uterine surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

  • Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstet Gynecol. 2013 Feb;121(2 Pt 1):247-252. doi: 10.1097/AOG.0b013e31827e5dca.

    PMID: 23303106RESULT

  • 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

Results Point of Contact

Title
Jeanine Carbone MD
Organization
Washington University School of Medicine
jfcarbone@hotmail.com
314-362-8523

Study Officials

  • Jeanine F Carbone, MD

    Washington University School of Medicine

    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

January 6, 2011

First Posted

January 19, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

May 3, 2019

Results First Posted

May 1, 2019

Record last verified: 2019-05

Locations

US(1)