Clinical trial NCT00468299: MiMi: A Randomized Trial of Mifepristone and Misoprostol for Treatment of Early Pregnancy Failure
Official title: Treatment of Early Pregnancy Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Early Pregnancy Failure
Miscarriage
Fetal Demise
Anembryonic Pregnancy
Keywords: early
pregnancy
failure
mifepristone
misoprostol
buccal
miscarriage
fetal
demise
anembryonic
progesterone
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2007-05-02
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age \>18yrs, able to read and write English
* Intrauterine gestations with anembryonic sac between 10 and 45mm or
* 10-15mm sac with no growth in three days or other radiologic signs of abnormal pregnancy such as irregular sac or debris within the gestational sac
* An embryonic pole \<30mm with no cardiac activity

Exclusion Criteria:

* Intrauterine gestations with CRL \<5mm or \>30mm without cardiac activity
* Incomplete abortion as defined as open cervix and large amount of cramping/bleeding
* Hemodynamic instability and/or heavy vaginal bleeding
* Hemoglobin less than or equal to 8
* Inability to follow-up (ie, lack of transportation or access to telephone)
* Bleeding disorder or taking anticoagulants
* Prior medical or surgical treatment of the current pregnancy
* Obvious Infection
* Active Lactation
* Allergy to mifepristone or misoprostol
* Chronic corticosteroid use
* Severe gastrointestinal disease (e.g inflammatory bowel disease, severe gastritis)

Primary outcomes:
measure: Number of Women With Complete Abortion 24-48hrs After Receiving Medical Treatment for Early Pregnancy Failure.
timeFrame: 24-48 hrs
Secondary outcomes:
measure: Complete Abortion at One Week
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: Boston University
name: Sarah J Betstadt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston University
name: Olivera Vragovic, MBA
role: STUDY_DIRECTOR
References:
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