Cervical Foley Plus Vaginal Misoprostol for Labor Induction

NCT ID: NCT01279343

Last Updated: 2019-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2014-03-31

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.

Detailed Description

More than 22% of all gravid women undergo induction of labor in the United States for various indications. Although there are several techniques and methods for induction of labor, the best agent and method still remains uncertain. To date, there has been no randomized trial comparing foley bulb plus vaginal misoprostol versus vaginal misoprostol alone. The combination of a mechanical device (foley bulb) and synthetic prostaglandin may have an additive or synergistic effect, resulting in greater degree of cervical ripening and shorter induction to delivery time (IDT). The addition of a synthetic prostaglandin to the foley bulb may also overcome the frequent observation of cervical dilation to 4cm by the foley bulb without effacement.

Conditions

Induction of Labor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Foley Bulb plus Misoprostol

Group Type: EXPERIMENTAL

Foley bulb

Intervention Type: DEVICE

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

Misoprostol

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Foley bulb

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

Intervention Type: DEVICE

Other Intervention Names

cytotec

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeanine F Carbone, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Barnes Jewish Hospital

St Louis, Missouri, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 23303106 (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)

Other Identifiers

10-1135-201107249

Identifier Type: -

Identifier Source: org_study_id