Mifepristone Plus Misoprostol Versus Misoprostol Alone for 2nd Trimester Abortion (14 - 21 Weeks Last Menstrual Period (LMP))

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 120 women in each country 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+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 10 doses within 48 hours (maximum 5 doses per 24 hours). | 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 per 24 hours up to 48 hours.<br>|
| Active Comparator: misoprostol<br>Placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion up to a maximum of 10 doses within 48 hours (maximum 5 doses per 24 hours). | Drug: misoprostol+placebo<br>* placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours for a maximum of 5 doses per 24 hours up to 48 hours.<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. |  | 48 hours | 
| Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus. |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provision of additional interventions to manage excessive blood loss |  | from start of treatment until discharge | 
| Any heavy bleeding, uterine rupture, or infection requiring additional treatment |  | start of treatment until discharge | 
| 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. | 
| Women's acceptability of the assigned method |  | Assessed at 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