A Randomized Trial of Two Regimens of Misoprostol for Second Trimester Termination for Intrauterine Fetal Death
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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 |
- -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 ]
- 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: | August 2010 |
| Estimated Primary Completion Date: | October 2009 (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 |
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| Lebanon | |
| American University of Beirut Medical Center | |
| Beirut, Lebanon | |
| Principal Investigator: | Anwar H Nassar, MD | American University of Beirut Medical Center |
More Information
No publications provided
| Responsible Party: | Anwar Nassar, AUBMC |
| ClinicalTrials.gov Identifier: | NCT00141895 History of Changes |
| Other Study ID Numbers: | OGY.AN.03 |
| Study First Received: | September 1, 2005 |
| Last Updated: | March 14, 2011 |
| 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 Pregnancy Complications Death Pathologic Processes 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 May 19, 2013