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
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05969574 -
Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages?
|
||
Enrolling by invitation |
NCT01689428 -
Ism1 Versus EmbryoGen Media for Embryo Culture in Previous Pregnancy Loss Cases
|
Phase 3 | |
Completed |
NCT00194844 -
Couples Miscarriage Healing Project:Randomized Trial
|
Phase 1/Phase 2 | |
Recruiting |
NCT05789940 -
Hysteroscopy vs. Endouterine Aspiration in the Management of Trophoblastic Retention
|
N/A | |
Recruiting |
NCT03628625 -
Letrozole Pretreatment With Misoprostol fInduction of Abortion In First-Trimester Missed Miscarriage
|
Phase 2 | |
Not yet recruiting |
NCT05557201 -
Cohort of Patients Presenting Unexplained Recurrent Miscarriages and Identification of Early Miscarriage Recidivism Factors
|
||
Not yet recruiting |
NCT05579756 -
Psychatric Impact of Miscarriage in Assiut University Hospital
|
||
Not yet recruiting |
NCT05039853 -
Improving Mental Health Following Early PREgnancy Loss Using a Brief Cognitive Task
|
N/A | |
Recruiting |
NCT01223482 -
A Study Looking at Women's Experiences After a Miscarriage
|
N/A | |
Completed |
NCT04604366 -
Comparison of Vaginal Versus Sublingual Misoprostol in the Treatment of First Trimester Missed Miscarriage
|
Phase 2 | |
Not yet recruiting |
NCT05088720 -
Misoprostol for Management of Women With an Incomplete Miscarriage
|
N/A | |
Not yet recruiting |
NCT05088707 -
Sublingual Versus Vaginal Misoprostol In Medical Treatment of Second Trimestric Missed Miscarriage
|
N/A | |
Not yet recruiting |
NCT05103098 -
Sublingual Misoprostol In Medical Treatment of First Trimester Missed Miscarriage
|
N/A | |
Not yet recruiting |
NCT05094375 -
Vaginal Misoprostol In Medical Treatment of First Trimester Missed Miscarriage
|
N/A | |
Recruiting |
NCT05304273 -
Comparison Between Letrozole and Mifepristone in Medical Termination of First Trimester Miscarriages
|
Phase 3 | |
Not yet recruiting |
NCT05653414 -
Interest of a Short Early Psychological Care in Women With Miscarriage
|
N/A | |
Recruiting |
NCT03976544 -
Natural Cycle Versus Hormone Replacement Therapy Cycle for a Frozen-thawed Embryo Transfer in PGT Patients
|
Phase 4 | |
Completed |
NCT01916928 -
The Use of Cell Free Fetal DNA in the Maternal Blood in the Evaluation of Intrauterine Fetal Demise and Miscarriage
|
N/A | |
Completed |
NCT03940495 -
Serum Kisspeptin: a Predictive Marker of Miscarriage or Not?
|
||
Completed |
NCT04512820 -
Treatment of Missed Miscarriage With TRUCLEAR Tissue Removal System, a Feasiblity Study
|
N/A |