MiMi: A Randomized Trial of Mifepristone and Misoprostol for Treatment of Early Pregnancy Failure (MiMi)
|Early Pregnancy Failure Miscarriage Fetal Demise Anembryonic Pregnancy||Drug: Misoprostol and placebo Drug: Mifepristone and misoprostol|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Treatment of Early Pregnancy Failure|
- Number of Women With Complete Abortion 24-48hrs After Receiving Medical Treatment for Early Pregnancy Failure. [ Time Frame: 24-48 hrs ]
- Complete Abortion at One Week [ Time Frame: 3 weeks ]Complete abortion at one week; uterus demonstrated to be empty on transvaginal ultrasound
|Study Start Date:||April 2007|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Misoprostol and placebo
Women in this arm receive placebo and misoprostol 800 mcg buccally
Drug: Misoprostol and placebo
Women in this group receive 800 mcg misoprostol plus a placebo
Experimental: Mifepristone and misoprostol
Womwn in this group receive mifepristone 200 mg orally and misoprostol 800 mcg buccally
Drug: Mifepristone and misoprostol
This group receives mifepristone 200 mg orally; followed by 800 mcg misoprostol bucally
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00468299
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Sarah J Betstadt, MD||Boston University|
|Study Director:||Olivera Vragovic, MBA||Boston University|