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A Randomized Trial of Two Regimens of Misoprostol for Second Trimester Termination for Intrauterine Fetal Death
This study is currently recruiting participants.
Verified by American University of Beirut Medical Center, August 2008
Sponsored by: American University of Beirut Medical Center
Information provided by: American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT00141895
  Purpose

Misoprostol (Cytotec®) is a synthetic prostaglandin E1 analog that has been marketed in the United States since 1988 as a gastric cytoprotective agent. Despite a focused campaign by the manufacturer to curtail its use in obstetric practice, misoprostol has, over the past several years, gained widespread acceptance to effect the medical termination of pregnancy in the second trimester, either alone or after pretreatment with mifepristone. The primary reasons for this prompt incorporation into standard practice include its low cost and the lack of stringent storage requirements.

Vaginal administration seems to be more efficacious than when given orally. The use of sublingual misoprostol for first trimester abortions has been extensively investigated as evidenced by the large number of publications comparing sublingual to other routes of misoprostol for first trimester pregnancy termination, on the assumption that the sublingual route would have a similar efficacy of the vaginal route. In addition, the sublingual route would combine an easier administration with the added advantage of no restriction of mobility after administration. There has been no previous report in the literature comparing the use of misoprostol given sublingually to that given vaginally for the second trimester termination following intrauterine fetal death. Our aim is to compare efficacy, safety and patient satisfaction with misoprostol given vaginally (the current standard) to that given sublingually.


Condition Intervention Phase
Labor Induction
Drug: Misoprostol
Phase III

Drug Information available for: Misoprostol
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Efficacy Study
Official Title: A Randomized Trial of Two Regimens of Misoprostol for Second Trimester Intrauterine Fetal Death

Further study details as provided by American University of Beirut Medical Center:

Primary Outcome Measures:
  • -The main outcome measures will be the induction time, defined as the time from placement of the first dose of misoprostol until the time of delivery of the fetus. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The entry characteristics of the patients, including age, height, weight, parity, gestational age at induction, indication for the induction, and cervical score before the start of the induction [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • The delivery rate within 24 hours of prostaglandin commencement [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Number of doses of misoprostol given [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Number of unsuccessful inductions [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Need for surgical intervention to remove the placenta [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2004
Estimated Study Completion Date: August 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Active Comparator
Vaginal Cytotec
Drug: Misoprostol
2 tablets 200 micrograms Vaginal route
B: Active Comparator
Sublingual Cytotec
Drug: Misoprostol
2 tablets of 200 micrograms Sublingual route

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 14 and 24 weeks of gestation
  • Both nulliparous and multiparous women
  • An unfavorable cervix (Bishop's score less than 8)

Exclusion Criteria:

  • Known contraindications to the use of prostaglandins (e.g. asthma)
  • Previous uterine scar (previous cesarean or myomectomy where the endometrial cavity was entered)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141895

Contacts
Contact: Anwar H Nassar, MD +961-1-340460 ext 5607 an21@aub.edu.lb

Locations
Lebanon
American University of Beirut Medical Center Recruiting
Beirut, Lebanon
Contact: Adnan Mroueh, MD     +961-350000 ext 5600     am36@aub.edu.lb    
Sub-Investigator: Ihab M Usta, MD            
Sub-Investigator: Johnny Awwad, MD            
Sub-Investigator: Muhieddine Seoud, MD            
Sub-Investigator: Adnan Mroueh, MD            
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
Principal Investigator: Anwar H Nassar, MD American University of Beirut Medical Center
  More Information

Responsible Party: AUBMC ( Anwar Nassar )
Study ID Numbers: OGY.AN.03
Study First Received: September 1, 2005
Last Updated: August 27, 2008
ClinicalTrials.gov Identifier: NCT00141895  
Health Authority: Lebanon: Institutional Review Board

Keywords provided by American University of Beirut Medical Center:
Intrauterine fetal death, 2nd trimester, induction

Study placed in the following topic categories:
Death
Pregnancy Complications
Misoprostol
Fetal Death

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

ClinicalTrials.gov processed this record on January 13, 2009