A Randomized Trial of Two Regimens of Misoprostol for Second Trimester Termination for Intrauterine Fetal Death
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ClinicalTrials.gov Identifier: NCT00141895 |
Recruitment Status :
Terminated
(Difficulty recruiting)
First Posted : September 2, 2005
Last Update Posted : July 19, 2013
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Labor Induction | Drug: Misoprostol | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 73 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Trial of Two Regimens of Misoprostol for Second Trimester Intrauterine Fetal Death |
Study Start Date : | September 2004 |
Actual Primary Completion Date : | October 2008 |
Actual Study Completion Date : | November 2008 |

Arm | Intervention/treatment |
---|---|
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 |
- -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 ]
- 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 ]
- The delivery rate within 24 hours of prostaglandin commencement [ Time Frame: 48 hours ]
- Number of doses of misoprostol given [ Time Frame: 48 hours ]
- Number of unsuccessful inductions [ Time Frame: 48 hours ]
- Length of hospital stay [ Time Frame: 48 hours ]
- Need for surgical intervention to remove the placenta [ Time Frame: 24 hours ]

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Ages Eligible for Study: | 16 Years to 45 Years (Child, Adult) |
Sexes 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00141895
Lebanon | |
American University of Beirut Medical Center | |
Beirut, Lebanon |
Principal Investigator: | Anwar H Nassar, MD | American University of Beirut Medical Center |
Responsible Party: | Anwar Nassar, professor, American University of Beirut Medical Center |
ClinicalTrials.gov Identifier: | NCT00141895 |
Other Study ID Numbers: |
OGY.AN.03 |
First Posted: | September 2, 2005 Key Record Dates |
Last Update Posted: | July 19, 2013 |
Last Verified: | July 2013 |
Intrauterine fetal death, 2nd trimester, induction |
Fetal Death Stillbirth Death Pathologic Processes Pregnancy Complications Misoprostol Abortifacient Agents, Nonsteroidal |
Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Anti-Ulcer Agents Gastrointestinal Agents Oxytocics |