A Comparison of Sublingual and Buccal Misoprostol Regimens After Mifepristone for Mid-trimester Abortion

Study Overview
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Brief Summary
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The primary goal of this study is to directly compare repeat doses of sublingual and buccal routes of 400 mcg misoprostol following mifepristone for second trimester abortion in order to determine if sublingual route confers an advantage with respect to efficacy and median time to complete abortion.

Detailed Description
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Eligible women 13-21 weeks gestation who give informed consent will be randomized to receive buccal or sublingual misoprostol. Participants will take 200mg mifepristone and return to the hospital 24 hours later to begin induction with misoprostol. 400mcg misoprostol will be given every 3 hours until the expulsion of the fetus and placenta.

Official Title
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A Randomized Controlled Trial to Compare Sublingual and Buccal Misoprostol Regimens After Mifepristone for Termination of Pregnancy 13 - 21 Weeks From Last Menstrual Period (LMP)

Conditions
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Legally Induced Abortion Without Mention of Complication

Intervention / Treatment
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* Drug: Mifepristone
* Drug: Buccal misoprostol
* Drug: Sublingual misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet 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 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sublingual misoprostol<br>200mg mifepristone + 400mcg sublingual misoprostol q3h | Drug: Mifepristone<br>* 200mg oral mifepristone to both study arms<br>* Other names: Mifegyne;Drug: Sublingual misoprostol<br>* doses of sublingual misoprostol every 3 hours beginning 24 hours after mifepristone<br>* Other names: cytotec;|
| Active Comparator: Buccal misoprostol<br>200mg mifepristone + 400mcg buccal misoprostol q3h | Drug: Mifepristone<br>* 200mg oral mifepristone to both study arms<br>* Other names: Mifegyne;Drug: Buccal misoprostol<br>* doses of buccal misoprostol every 3 hours beginning 24 hours after mifepristone<br>* Other names: cytotec;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of successful abortion by 24 hours | Defined as complete evacuation of uterus at 24 hours following start of misoprostol, using study drugs without recourse to any additional intervention. | 24 hours following the start of misoprostol | 
| Rate of successful abortion by 48 hours | Defined as complete evacuation of uterus at 48 hours following start of misoprostol, using study drugs without recourse to any additional intervention. | 48hours following the start of misoprostol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median time from first dose of misoprostol to complete expulsion of complete expulsion (provider diagnosis of complete expulsion of fetus and placenta). |  | 48 hours | 
| Percentage of patients requiring provision of additional interventions. |  | from first drug dose to complete expulsion as documented on study forms, up to 72 hours | 
| Total number of doses of misoprostol. |  | from first drug dose to complete expulsion as documented on study forms, up to 72 hours | 
| Rates of heavy bleeding, uterine rupture, or infection requiring additional treatment |  | 1 month | 
| Pain scale (1-7) as reported by women on questionnaire |  | from first drug dose to complete expulsion as documented on study forms, up to 72 hours | 
| Women's acceptability of the assigned method based on 5 point acceptability scale in questionnaire |  | from first drug dose to complete expulsion as documented on study forms, up to 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Buccal, Second Trimester, Abortion, Misoprostol, Sublingual