Cervical Foley Plus Vaginal Misoprostol for Labor Induction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01279343
Recruitment Status : Unknown
Verified August 2011 by Washington University School of Medicine.
Recruitment status was:  Recruiting
First Posted : January 19, 2011
Last Update Posted : August 3, 2011
Information provided by:
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Induction of Labor Device: Foley bulb Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cervical Foley Plus Vaginal Misoprostol Versus Vaginal Misoprostol for Cervical Ripening and Labor Induction: A Randomized Trial
Study Start Date : January 2011
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Time from start of labor induction to vaginal delivery [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. Successful number of vaginal deliveries [ Time Frame: 72 hours ]
    To compare the number of vaginal deliveries to failed inductions requiring cesarean deliveries.

  2. tachysystole requiring terbutaline use [ Time Frame: 72 hours ]
  3. Post-partum hemorrhage [ Time Frame: 96 hours ]
  4. Chorioamnionitis [ Time Frame: 96 hours ]
  5. neonatal APGAR scores [ Time Frame: 10 minutes ]
    APGAR scores will be recorded at 1, 5 and 10 minutes after birth.

  6. NICU admission [ Time Frame: 96 hours ]
  7. Time to complete cervical dilation [ Time Frame: 72 hours ]
    We will record the start time of induction until the patient's cervix is 10cm dilated

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01279343

Contact: Jeanine F Carbone, MD 314-362-7300
Contact: Patricia Fogertey, RN, MSN

United States, Missouri
Barnes Jewish Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: Jeanine F Carbone, MD Washington University School of Medicine

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jeanine F. Carbone, MD, Washington University Identifier: NCT01279343     History of Changes
Other Study ID Numbers: 10-135
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: August 3, 2011
Last Verified: August 2011

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

Additional relevant MeSH terms:
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents