Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial

Study Overview
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Brief Summary
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The purpose of the proposed study is to compare - in a randomized, placebo-controlled, double-blinded trial - a combination of mifepristone and misoprostol to misoprostol used alone for missed abortion.

Detailed Description
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The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of missed abortion. This will be a randomized controlled double-blinded trial of 416 women comparing misoprostol alone to mifepristone plus misoprostol for treatment of missed abortion less than 13 weeks+ 0 days LMP. All women in the trial will undergo routine screening (including ultrasound) and pre-medical induction care per standard practice at the hospital. All eligible women agreeing to participate in the study will be randomized to receive one of the following regimens: 1) STUDY GROUP ONE: 200mg mifepristone followed in 24 hours by 800mcg sublingual misoprostol; 2) STUDY GROUP TWO: placebo followed in 24 hours by 800mcg sublingual misoprostol.

Official Title
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Mifepristone and Misoprostol Versus Misoprostol Alone for Missed Abortion: A Randomized-controlled Trial

Conditions
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Missed Abortion, Pregnancy

Intervention / Treatment
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* Drug: Mifepristone
* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ultrasound examination demonstrating: Evidence of fetal demise (no fetal cardiac activity despite recognizable embryo and dates consistent with the likelihood of visible pregnancy) OR Empty gestational sac with no evidence of incomplete abortion or growth over a 7-day period confirmed by two ultrasounds performed one week apart. If fetus exists, fetal size less than 12 weeks+6 days Closed cervical os Eligible to consent for research according to local regulations Exclusion Criteria: Active bleeding at enrollment and/or history of bleeding within the prior week Allergies or other contraindications to the use of mifepristone or misoprostol Suspected ectopic pregnancy History of trophoblastic disease Coagulation disorder and/or currently taking anticoagulants Any serious medical condition

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mifepristone-misoprostol regimen<br>After a woman is determined eligible and signs the informed consent document, she will receive 200 mg mifepristone and advised to swallow the pill when they arrive at home. 24 hours after administration of the mifepristone, women will administer the four tablets of 200 mcg misoprostol sublingually. | Drug: Mifepristone<br>* Mifepristone for treatment of missed abortion<br>Drug: Misoprostol<br>* Misoprostol for treatment of missed abortion<br>|
| Placebo Comparator: Misoprostol alone regimen<br>After a woman is determined eligible and signs the informed consent document, she will receive a placebo (of same shape and size of mifepristone) and advised to swallow the pill when they arrive at home. 24 hours after administration of the mifepristone, women will administer the four tablets of 200 mcg misoprostol sublingually. | Drug: Misoprostol<br>* Misoprostol for treatment of missed abortion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful evacuation of the uterus | uterine evacuation without the need for uterine aspiration or other surgery | 1 week after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful evacuation without any additional intervention | uterine evacuation without the need for vacuum aspiration, additional uterotonics or other intervention | 1 week after treatment | 
| Excessive bleeding or a complication for which a woman received treatment |  | 30 days after treatment | 
| Induction expulsion interval after misoprostol administration | time interval between misoprostol administration and the expulsion | one week follow-up | 
| Acceptability of assigned method to women |  | one week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reproductive health, mifepristone, misoprostol, obstetrics, pregnancy, abortion, missed abortion