Comparative Effectiveness of Pregnancy Failure Management Regimens

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the effectiveness of combination treatment (mifepristone premedication plus single-dose misoprostol) to single-dose misoprostol (standard of care) for the management of early pregnancy failure.

Official Title
-----------------
Comparative Effectiveness of Pregnancy Failure Management Regimens

Conditions
-----------------
Spontaneous Abortion

Intervention / Treatment
-----------------
* Drug: Misoprostol
* Drug: Mifepristone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: between 5 and 12 completed weeks gestation 18 years or older hemodynamically stable confirmed diagnosis of intrauterine embryonic/fetal demise or anembryonic gestation (ultrasound examination demonstrates a fetal pole without cardiac activity measuring between 5.3 and 40 mm or an abnormal growth pattern diagnostic of early pregnancy failure) willing and able to give informed consent Exclusion Criteria: diagnosis of incomplete or inevitable abortion (absent gestational sac and/or active bleeding, open cervical os) contraindication to mifepristone (chronic corticosteroid administration, adrenal disease) contraindication to misoprostol (glaucoma, mitral stenosis, sickle cell anemia, or known allergy to prostaglandin) cardiovascular disease (angina, valvular disease, arrhythmia, or cardiac failure) most recent hemoglobin <9.5 g/dL diagnosis of porphyria known clotting defect or receiving anticoagulants pregnancy with an intrauterine device (IUD) in place breastfeeding during the first 7 days of study participation unwilling to comply with the study protocol and visit schedule any evidence of viable pregnancy possibility of ectopic pregnancy known or suspected pelvic infection concurrent participation in any other interventional trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: misoprostol plus mifepristone<br>800 micrograms vaginal misoprostol, preceded by 200 milligrams oral mifepristone 24 hours prior | Drug: Misoprostol<br> <br> * Other names: Cytotec;Drug: Mifepristone<br> <br> * Other names: Mifeprex;|
| Active Comparator: misoprostol<br>800 micrograms of vaginal misoprostol alone | Drug: Misoprostol<br> <br> * Other names: Cytotec;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational Sac Expulsion With One Treatment Dose on Day 3 (Visit 2) and no Need for Additional Medical or Surgical Intervention Within 30 Days of Treatment. |  | Day 3 (visit 2) and up to 30 days following visit (to ensure surgical measures were not done | 
| Gestational Sac Expulsion by the Second Follow-up Visit at Day 8 |  | Day 8 (visit 3) and up to 30 day to ensure additional measures were not done (surgical) | 
| Gestational Sac Expulsion by the 30-day Telephone Call |  | 30 Days | 
| Uterine Asperation | Surgical removal of the miscarriage. | 30 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Serious Adverse Events Between Study Arms. |  | 30 days | 
| Adverse Event Reported by Participants |  | 30 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spontaneous abortion, Early Pregnancy Failure, Mifepristone, Misoprostol