Buccal Versus Vaginal Misoprostol for Third Trimester Induction of Labor
This study is currently recruiting participants.
Verified January 2012 by University of California, Los Angeles
Sponsor:
University of California, Los Angeles
Information provided by (Responsible Party):
Ram Parvataneni MD, MPH, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01519765
First received: January 5, 2012
Last updated: January 26, 2012
Last verified: January 2012
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Purpose
Approximately 22% of term pregnancies are induced. Misoprostol, a prostaglandin E1 analogue, is a widely accepted induction agent, that has been proven safe and effective for induction of labor. It stimulates both cervical ripening and uterine contractions, thus making it an ideal induction agent for unfavorable cervices. Research has examined the pharmacokinetics of different administration routes and effects on uterine contractility, side effects, and safety. Vaginal misoprostol has been shown to be superior over oral administration however patients often prefer a more tolerable route. Buccal administration has already been shown to be as effective as vaginal misoprostol for cervical ripening and induction in both first trimester and second trimester abortions. There is minimal research comparing buccal versus vaginal for third trimester induction of labor. The investigators study is a prospective, double blinded, randomized control trial comparing vaginal misoprostol and buccal misoprostol in equal dosages of 25 mcg. The investigators seek to answer the question whether buccal misoprostol is as effective as vaginal misoprostol for third trimester induction of labor.
| Condition | Intervention | Phase |
|---|---|---|
|
Pregnancy |
Drug: Buccal Misoprostol Drug: Vaginal misoprostol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Buccal Versus Vaginal Misoprostol for the Third Trimester Induction of Labor |
Resource links provided by NLM:
Further study details as provided by University of California, Los Angeles:
Primary Outcome Measures:
- Efficacy of buccal misoprostol versus vaginal misoprostol for third trimester induction of labor [ Time Frame: Until delivery (up to 72 hrs) ] [ Designated as safety issue: No ]The main outcome variable is vaginal delivery within 24 hours of induction.
Secondary Outcome Measures:
- Patient satisfaction with buccal versus vaginal misoprostol administration. [ Time Frame: Until delivery (up to 72hrs) ] [ Designated as safety issue: No ]Gastrointestinal side effects Patient preferred route of administration Patients will be followed for the duration of their labor(usually up to 72hrs). The satisfaction survey will be conducted after delivery but will evaluate side effects that they recollect in labor
- Efficacy of buccal misoprostol versus vaginal misoprostol for third trimester induction of labor [ Time Frame: Until delivery (up to 72 hrs) ] [ Designated as safety issue: No ]Induction to delivery time, Induction to active labor time, Duration of labor, Number of misoprostol doses needed, Need for augmentation with pitocin, Cesarean section secondary to fetal distress, Cesarean section secondary to failed induction of labor, Chorioamnionitis, non reassuring fetal status. Patients will be followed for the duration of their labor(usually up to 72hrs)
| Estimated Enrollment: | 250 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Buccal misoprostol+placebo vaginal pill |
Drug: Buccal Misoprostol
Buccal rather than Vaginal misoprostol for induction of labor
Other Name: Cytotec
|
| Active Comparator: Vaginal Misoprostol+placebo buccal pill |
Drug: Vaginal misoprostol
Vaginal rather than buccal misoprostol for induction of labor
Other Name: Cytotec
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Willingness to participate / consent in a placebo-controlled trial
- Age 18 and older
- Pregnancy between 34 and 42 years of gestation
- Admitted for labor induction because of either medical, obstetric, or psychosocial indications
- Live singleton fetus
- Bishop score less than or equal to six
- Cephalic presentation
- Reactive non-stress test or Negative contraction test
Exclusion Criteria:
- Premature rupture of membranes
- Multiparity > 5
- Contraindication to vaginal or labor delivery
- Suspected placental abruption
- Significant hepatic, renal or cardiac disease
- Known hypersensitivity to misoprostol or prostaglandin analogue
- Recent prostaglandin administration for induction of labor
- Multifetal pregnancy
- Macrosomia > 4500g estimated fetal weight by ultrasound or leopold
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01519765
Contacts
| Contact: Linh Tran, MD | 310 825 6301 | LinhTran@mednet.ucla.edu |
| Contact: Amy Shah, MD | 310 825 6301 | AShah@mednet.ucla.edu |
Locations
| United States, California | |
| Ronald Reagan UCLA Medical Center | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Sub-Investigator: Linh Tran, MD | |
Sponsors and Collaborators
University of California, Los Angeles
Investigators
| Principal Investigator: | Ram Parvataneni, MD | Assistant Clinical Professor |
More Information
Additional Information:
No publications provided
| Responsible Party: | Ram Parvataneni MD, MPH, Assistant Clinical Professor of Obstetrics and Gynecology, University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT01519765 History of Changes |
| Other Study ID Numbers: | UCLA IRB#11-002056 |
| Study First Received: | January 5, 2012 |
| Last Updated: | January 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
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