Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation

Study Overview
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Brief Summary
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A randomized double---blinded comparison of same---day mifepristone and misoprostol with misoprostol only for cervical preparation in second---trimester surgical abortion in 100 women at 14 0/7---19 6/7 weeks gestation.

Detailed Description
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Women desiring abortion at gestational ages between 14 weeks 0 days and 19 weeks 6 days were randomized to 200-mg mifepristone or identical placebo with 400-mcg misoprostol vaginally 4-6 hours prior to D&E. Primary outcome was cervical dilation assessed by the largest Hegar dilator accepted without resistance. Secondary outcomes included total procedure time, and patient and provider perceptions. The study was powered to detect a 2-mm difference in cervical dilatation with 48 participants in each arm.

Official Title
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A Randomized Comparison of Same-Day Oral Mifepristone-Misoprostol to Misoprostol Only for Cervical Preparation in Second Trimester Surgical Abortion

Conditions
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Induced Abortion

Intervention / Treatment
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* Drug: Mifepristone
* Drug: Misoprostol
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy women eligible for non---urgent D&E 14 0/7 weeks to 19 6/7 weeks gestation, confirmed by sonogram Exclusion Criteria: emergent need for D&E fetal demise intolerance allergy or contraindication to mifepristone or misoprostol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mifepristone<br>Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once | Drug: Mifepristone<br>* Progesterone antagonist<br>* Other names: Mifeprex;Drug: Misoprostol<br>* Prostaglandin E1<br>* Other names: Cytotec;|
| Placebo Comparator: Placebo<br>Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once | Drug: Misoprostol<br>* Prostaglandin E1<br>* Other names: Cytotec;Dietary Supplement: Placebo<br>* Tasteless, odorless, sugar based pill<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial Cervical Dilation | Initial cervical dilation as measured by Hegar Dilator accepted with least resistance | Assessed 4-6 hour following medications at time of D&E procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Acceptability and Assessment of Pain and Side Effects (5-point Likert Scale) | 5-point Likert scale given to patients following procedure once recovered from anesthesia assessing pain, side effects including nausea, vomiting, diarrhea, cramping, and if they would choose the method again or recommend to friends. Likert scale: Strongly agree (5), Agree (4), Neutral (3), Disagree (2), Strongly Disagree (1) | intraoperative |