A Randomized Trial of Two Regimens of Misoprostol for Second Trimester Termination for Intrauterine Fetal Death

This study has been terminated.
(Difficulty recruiting)
Sponsor:
Information provided by (Responsible Party):
Anwar Nassar, American University of Beirut Medical Center
ClinicalTrials.gov Identifier:
NCT00141895
First received: September 1, 2005
Last updated: July 18, 2013
Last verified: July 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of Two Regimens of Misoprostol for Second Trimester Intrauterine Fetal Death

Resource links provided by NLM:


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 ]

Enrollment: 73
Study Start Date: September 2004
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Vaginal Cytotec at doses of 400 microgram every 4 hours until delivery
Drug: Misoprostol
2 tablets 200 micrograms Vaginal route
Other Name: Cytotec
Active Comparator: B
Sublingual Cytotec at doses of 400 microgram every 4 hours until delivery
Drug: Misoprostol
2 tablets of 200 micrograms Sublingual route
Other Name: Cytotec

  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
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: NCT00141895

Locations
Lebanon
American University of Beirut Medical Center
Beirut, Lebanon
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
Principal Investigator: Anwar H Nassar, MD American University of Beirut Medical Center
  More Information

No publications provided

Responsible Party: Anwar Nassar, professor, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT00141895     History of Changes
Other Study ID Numbers: OGY.AN.03
Study First Received: September 1, 2005
Last Updated: July 18, 2013
Health Authority: Lebanon: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014