Other Abortion Clinical Trial
Official title:
Comparison Between Sublingual Misoprostol vs. Sublingual Misoprostol and Laminaria For Second Trimester Termination of Pregnancy
Verified date | December 2013 |
Source | Rambam Health Care Campus |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ethics Commission |
Study type | Interventional |
1. Comparison between the duration of time from the beginning of cervical preparation
until abortion, between sublingual misoprostol and the combination of sublingual
misoprostol with laminaria for second trimester medical termination of pregnancy (TOP).
2. Comparison between the adverse event rate following Sublingual misoprostol only vs.
Sublingual misoprostol and laminaria given for pregnancy termination.
3. Comparison between the levels of satisfaction rate of women who underwent pregnancy
termination with sublingual misoprostol vs. sublingual misoprostol with laminaria.
Status | Enrolling by invitation |
Enrollment | 100 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: Second trimester pregnancy No evidence of chorioamnionitis Exclusion Criteria: Allergy to misoprostol. Evidence for infection. Asthma |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Israel | Rambam Health Campus | Haifa |
Lead Sponsor | Collaborator |
---|---|
Rambam Health Care Campus |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of time until pregnancy termination | From the time of receiving the treatment until complete abortion | Average time 12 hours | No |
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