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This open-label, randomized study is being conducted to determine whether a dose of 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable at inducing an abortion compared with misoprostol taken orally.
The goal of this study is to provide answers to the following four questions:
1. Is a regimen of medical abortion with mifepristone using sublingual misoprostol at least as effective as using oral misoprostol up to 63 days since the last menstrual period (LMP)?
2. Are the side effects with sublingual use tolerable for women?
3. Is sublingual administration of misoprostol acceptable to women?
4. Is one of the regimens (sublingual or oral) superior in terms of efficacy, safety (side-effects) or acceptability?
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
State University of Medicine and Pharmacy
Moldova, Republic of
Gynuity Health Projects
Published on BioPortfolio: 2014-08-27T03:46:22-0400
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Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion - a Double Blinded Randomized Controlled Trial
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Abortion induced to save the life or health of a pregnant woman. (From Dorland, 28th ed)
Any type of abortion, induced or spontaneous, that is associated with infection of the UTERUS and its appendages. It is characterized by FEVER, uterine tenderness, and foul discharge.
A mammalian fetus expelled by INDUCED ABORTION or SPONTANEOUS ABORTION.
Results of conception and ensuing pregnancy, including LIVE BIRTH; STILLBIRTH; SPONTANEOUS ABORTION; INDUCED ABORTION. The outcome may follow natural or artificial insemination or any of the various ASSISTED REPRODUCTIVE TECHNIQUES, such as EMBRYO TRANSFER or FERTILIZATION IN VITRO.
Individuals requesting induced abortions.
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