Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14-21 Weeks LMP)
Summary
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 controlled double-blinded trial of 20 women comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Conditions
Abortion, Induced
Intervention
Mifepristone+misoprostol, Placebo+Misoprostol
Location
University of Puerto Rico, University District Hospital Medical Science Campus
San Juan
Puerto Rico
00936-5067
Status
Not yet recruiting
Source
Gynuity Health Projects
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00957346
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Misoprostol
A synthetic analog of natural prostaglandin E1. It produces a dose-related inhibition of gastric acid and pepsin secretion, and enhances mucosal resistance to injury. It is an effective anti-ulcer agent and also has oxytocic properties.
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.
Clinical Trials
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 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...
Comparing Methotrexate Followed by Misoprostol to Misoprostol Alone for Early Abortion
Background: In most countries in which abortion is legal, medical abortions are induced with mifepristone and misoprostol. Since mifepristone is expensive and unavailable in many countries...
This open-label, randomized study will compare the efficacy, safety, and acceptability of mifepristone 200 mg followed in 24-36 hours either by buccal (i.e., in the cheeks) or oral misopro...
The Extended Gestational Age Medical Abortion Study
This open-label, comparative study will compare the efficacy, safety, and acceptability of 200 mg mifepristone followed in 24-48 hours by 800mcg buccal misoprostol or 400mcg sublingual mis...
PubMed Articles
OBJECTIVES: To evaluate the efficacy and safety of mifepristone and buccal misoprostol versus buccal misoprostol alone in medical abortion of ≤56 days....
Objective?To evaluate the efficacy and safety of home administration of buccal misoprostol after mifepristone for medical abortion up to 70 days' gestation in a general practice in Cura?ao, where indu...
Randomized trial of oral versus sublingual misoprostol 24 h after mifepristone for medical abortion.
OBJECTIVES: To assess the efficacy, side effects, and acceptability of medical abortion using oral mifepristone (200 mg) followed 24 h later by oral or sublingual misoprostol (400 mug). MATERIALS AND...
Objective To examine the efficacy, acceptability and feasibility of early medical abortion, with the option of home administration of misoprostol, in Uzbekistan. Methods A total of 450 women were enro...
OBJECTIVE: To compare the efficacy of 1-day and 2-day mifepristone and misoprostol intervals for second trimester termination of pregnancy between 13 and 16weeks. METHODS: A prospective randomized coh...
