Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation
Summary
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?
Study Design
Allocation: Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Induced Abortion
Intervention
Mifepristone, misoprostol
Location
State University of Medicine and Pharmacy
Chisinau
Moldova, Republic of
Status
Completed
Source
Gynuity Health Projects
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00286208
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:46:22-0400
Clinical Trials
The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized contr...
The primary goal of this study is to directly compare repeat doses of sublingual and buccal routes of 400 mcg misoprostol following mifepristone for second trimester abortion in order to d...
Non-surgical Alternatives to Treatment of Failed Medical Abortion
The primary outcome of this study is to compare the effectiveness of a second complete course of 200 mg mifepristone and 800 mcg misoprostol for ongoing pregnancy following mifepristone-mi...
This double-blind, randomized study will compare the efficacy and acceptability of mifepristone 200mg followed in 36-48 hours by 400mcg or 800mcg of buccal misoprostol (i.e., in the cheeks...
Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion
Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion - a Double Blinded Randomized Controlled Trial
PubMed Articles
The aim of the study was to examine the acceptability and feasibility of using a combined regimen of 200 mg mifepristone and 800 μg buccal misoprostol in an outpatient abortion service in Singapo...
In South Africa, access to second-trimester abortion services, which are generally performed using medical induction with misoprostol alone, is challenging for many women. We aimed to estimate the cos...
Simultaneous Compared With Interval Medical Abortion Regimens Where Home Use Is Restricted.
To evaluate outcomes with simultaneous administration of mifepristone and misoprostol for medical abortion at 63 days of gestation or less in the year after its implementation in a British clinic syst...
Harm Reduction for Abortion in the United States.
Access to abortion in the United States has eroded significantly. Accordingly, there is a growing movement to empower women to self-induce abortion. To date, physicians' roles and responsibilities in ...
Mifepristone Pretreatment for the Medical Management of Early Pregnancy Loss.
Medical management of early pregnancy loss is an alternative to uterine aspiration, but standard medical treatment with misoprostol commonly results in treatment failure. We compared the efficacy and ...
Medical and Biotech [MESH] Definitions
Abortion, Therapeutic
Abortion induced to save the life or health of a pregnant woman. (From Dorland, 28th ed)
Abortion, Septic
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.
Aborted Fetus
A mammalian fetus expelled by INDUCED ABORTION or SPONTANEOUS ABORTION.
Pregnancy Outcome
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.
Abortion Applicants
Individuals requesting induced abortions.
