Induction of Labor Clinical Trial
Official title:
A Randomized,Double-blind,Placebo-controlled, Multicenter Study of the Efficacy and Safety of Vaginal Misoprostol for Cervical Ripening and Induction of Labor
The purpose of this study is to estimate the efficacy and safety of the 25mcg vaginal misoprostol for cervical ripening and induction of labour.
There are many pregnant women require medical intervention to induce labor for some reasons
at term. There are two fundamental changes that characterize pre-labor preparation for
delivery: sensitization of the myometrium to produce contractions, and ripening (softening
and dilation) of the cervix. A synthetic Prostaglandin misoprostol is fundamental to both of
these changes. Low dose misoprostol is effective and safe for labor induction and has been
used widely.
Oral tablets(200mcg) are broken into fragments and used intravaginally to ripen the cervix
and induce labor due to the disadvantages of existing cervical ripeners (delivery of bolus
doses, freezer or refrigerated storage, lack of efficacy in labor induction), and due to
safety concerns with the off-label use of oral misoprostol tablet fragments, Regenex
Corporation has developed a vaginal tablet with 25mcg misoprostol.
The primary objective of the study was to assess of the efficacy and safety of low dose (25
mcg) of misoprostol vaginal tablet for cervical ripening and induction of labour.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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||
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Phase 1 | |
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Phase 4 | |
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Phase 4 | |
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Phase 4 | |
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Phase 2 | |
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| Completed |
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Early Phase 1 |