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Sponsored by: |
American University of Beirut Medical Center |
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Information provided by: | American University of Beirut Medical Center |
ClinicalTrials.gov Identifier: | NCT00141895 |
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 |
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Labor Induction |
Drug: Misoprostol |
Phase III |
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 |
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 |
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A: Active Comparator
Vaginal Cytotec
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Drug: Misoprostol
2 tablets 200 micrograms Vaginal route
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B: Active Comparator
Sublingual Cytotec
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Drug: Misoprostol
2 tablets of 200 micrograms Sublingual route
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Ages Eligible for Study: | 16 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Anwar H Nassar, MD | +961-1-340460 ext 5607 | an21@aub.edu.lb |
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 |
Principal Investigator: | Anwar H Nassar, MD | American University of Beirut Medical Center |
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 |
Intrauterine fetal death, 2nd trimester, induction |
Death Pregnancy Complications Misoprostol Fetal Death |
Pathologic Processes Oxytocics Therapeutic Uses Anti-Ulcer Agents Physiological Effects of Drugs |
Abortifacient Agents Gastrointestinal Agents Reproductive Control Agents Abortifacient Agents, Nonsteroidal Pharmacologic Actions |