Miscarriage Clinical Trial
Official title:
Treatment of Early Pregnancy Failure
The purpose of this study is to compare two combinations of drugs (mifepristone and misoprostol versus placebo and misoprostol) used for medical treatment for early pregnancy failure. We will compare the two combinations of medications to see which combination makes miscarriage happen faster. We hypothesize that there will be no difference in time to complete miscarriage between the two groups.
The optimal method of treating Early Pregnancy Failure (EPF) is not certain. For many years,
surgical management of EPF was the only treatment option. Now there are multiple studies
demonstrating the effectiveness of misoprostol for treating EPF. Most of the studies
investigating medical treatment of EPF have evaluated efficacy at one week. We have found
that many women do not want to wait for one week for an outcome of their medical treatment,
and want resolution sooner. This has hampered the widespread utilization of medical therapy
in our institution.
We propose a regimen of medical treatment for EPF with expeditious follow-up. We want to
demonstrate the relative efficacy of two medication regimens for treatment of EPF by
performing a randomized trial. One regimen will be 800μg buccal misoprostol alone and the
other regimen will be 200mg mifepristone, orally, in addition to 800μg buccal misoprostol,
simultaneously. The primary outcome will be complete abortion rates 24hours after medication
administration. We hypothesize that mifepristone will not improve complete abortion rates at
24hrs.
Secondary outcomes include rates of abortion by medical treatment at one week, the
indications for surgical intervention, relationship of progesterone levels and type of
pregnancy failure to outcomes in the two groups. Another secondary objective is to assess
satisfaction with the treatment process at the conclusion of pregnancy termination, and 3
weeks after the beginning of the process.
The majority of studies investigating medical treatment of EPF use vaginal misoprostol, but
buccal use is increasing. We will use buccal misoprostol, which is widely used at our
institution. We will assess the efficacy of this route of administration as well as assess
patient acceptability of this method.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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