Labor Induction Clinical Trial
Official title:
A Randomized Trial of Two Regimens of Misoprostol for Second Trimester Intrauterine Fetal Death
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.
Status | Terminated |
Enrollment | 73 |
Est. completion date | November 2008 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years to 45 Years |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Lebanon | American University of Beirut Medical Center | Beirut |
Lead Sponsor | Collaborator |
---|---|
American University of Beirut Medical Center |
Lebanon,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | -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. | 48 hours | No | |
Secondary | 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 | 48 hours | No | |
Secondary | The delivery rate within 24 hours of prostaglandin commencement | 48 hours | No | |
Secondary | Number of doses of misoprostol given | 48 hours | No | |
Secondary | Number of unsuccessful inductions | 48 hours | No | |
Secondary | Length of hospital stay | 48 hours | No | |
Secondary | Need for surgical intervention to remove the placenta | 24 hours | No |
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