Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14 - 21 Weeks LMP): A Randomized-controlled Double-blinded Trial

Study Overview
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Brief Summary
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The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized controlled double-blinded trial of 260 women comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.

Official Title
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Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14 - 21 Weeks LMP): A Randomized-controlled Double-blinded Trial

Conditions
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Abortion, Induced

Intervention / Treatment
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* Drug: mifepristone+misoprostol
* Drug: misoprostol
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 14 to 21 weeks gestation, based on menstrual history and clinical exam (with or without ultrasound) Meet legal criteria to obtain abortion Present with closed cervical os and no vaginal bleeding Live fetus at time of presentation for service Have no contraindications to study procedures, according to provider Be able to consent to procedure, either by reading consent document or by having consent document read to her Be willing to follow study procedures Exclusion Criteria: Known previous transmural uterine incision Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol Any contraindications to vaginal delivery, including placenta previa Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mifepristone+misoprostol<br>200 mg mifepristone followed by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses. | Drug: mifepristone+misoprostol<br>* single dose of 200 mg mifepristone followed 24 hours later by 800 mcg misoprostol administered buccally and repeated every 3 hours for a maximum of 5 doses.<br>Drug: misoprostol<br>* placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.<br>|
| Experimental: misoprostol<br>800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses. | Drug: misoprostol<br>* placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.<br>Drug: placebo<br>* placebo resembling mifepristone taken 24 hours before 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful abortion: defined as complete evacuation using study drug without recourse to any additional intervention. |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of fetal expulsion: defined as fetal expulsion with study drug alone. |  | 24 hours | 
| Induction-to-abortion interval |  | Time elapsed between administration of the first misoprostol dose until expulsion of the fetus. | 
| Total dose of misoprostol. |  | Assessed at time of complete abortion with study drug alone or when total maximum dose given. | 
| Pain experienced by the woman as self-reported. |  | Assessed during exit interview. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy termination, abortion, medical abortion, 2nd trimester, mifepristone, misoprostol