Cervical Foley Plus Vaginal Misoprostol for Labor Induction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Washington University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01279343
First received: January 6, 2011
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Induction of Labor
Device: Foley bulb

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cervical Foley Plus Vaginal Misoprostol Versus Vaginal Misoprostol for Cervical Ripening and Labor Induction: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Time from start of labor induction to vaginal delivery [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Successful number of vaginal deliveries [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    To compare the number of vaginal deliveries to failed inductions requiring cesarean deliveries.

  • tachysystole requiring terbutaline use [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
  • Post-partum hemorrhage [ Time Frame: 96 hours ] [ Designated as safety issue: Yes ]
  • Chorioamnionitis [ Time Frame: 96 hours ] [ Designated as safety issue: Yes ]
  • neonatal APGAR scores [ Time Frame: 10 minutes ] [ Designated as safety issue: Yes ]
    APGAR scores will be recorded at 1, 5 and 10 minutes after birth.

  • NICU admission [ Time Frame: 96 hours ] [ Designated as safety issue: Yes ]
  • Time to complete cervical dilation [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    We will record the start time of induction until the patient's cervix is 10cm dilated


Estimated Enrollment: 122
Study Start Date: January 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Foley Bulb plus Misoprostol Device: 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.
Other Name: cytotec
No Intervention: Misoprostol

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.

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279343

Contacts
Contact: Jeanine F Carbone, MD 314-362-7300 carboneje@wudosis.wustl.edu
Contact: Patricia Fogertey, RN, MSN fogerteyp@wudosis.wustl.edu

Locations
United States, Missouri
Barnes Jewish Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Jeanine F Carbone, MD Washington University Early Recognition Center
  More Information

No publications provided by Washington University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeanine F. Carbone, MD, Washington University
ClinicalTrials.gov Identifier: NCT01279343     History of Changes
Other Study ID Numbers: 10-135
Study First Received: January 6, 2011
Last Updated: August 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
labor induction
foley bulb
misoprostol

Additional relevant MeSH terms:
Misoprostol
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on July 23, 2014