Cervical Foley Plus Vaginal Misoprostol for Labor Induction
This study is currently recruiting participants.
Verified August 2011 by Washington University School of Medicine
Sponsor:
Washington University School of Medicine
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
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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
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 School of Medicine |
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 June 18, 2013