Buccal Versus Vaginal Misoprostol for Third Trimester Induction of Labor

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
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
  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
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: 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
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on August 28, 2014