Misoprostol Dose and Timing Before Surgical Abortion at 13 to 16 Weeks' Gestation: a Randomized Trial

Study Overview
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Brief Summary
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This study is a blinded randomized trial to compare two different doses and intervals of buccal misoprostol for cervical preparation before surgical abortion at 13 to 16 weeks' gestation: 400 mcg administered 3 hours before D&E (dilation and extraction), and 600 mcg administered 1.5 hours before D&E. Primary objective: To compare operative times after two different doses and intervals of misoprostol using a non-inferiority design. Secondary objectives: To compare the doses and intervals of misoprostol for differences in: (1) initial cervical dilation; (2) need for mechanical dilation and ease of dilation if required; (3) ability to complete the abortion procedure without further cervical preparation; (4) complications; (5) provider variables including ease of procedure and satisfaction with cervical preparation; (6) patient variables including pre-operative side effects, post-operative pain, and acceptability

Detailed Description
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The investigators compared two doses and intervals of buccal misoprostol for cervical preparation before surgical abortion at 13 to 16 weeks' gestation. This blinded randomized trial compared 400 mcg misoprostol administered 3 hours and 600 mcg administered 1.5 hours before abortion. The investigators analyzed results for the primary outcome (procedure time) using a non-inferiority limit of 3 or more minutes. The investigators tested two separate non-inferiority hypotheses each powered at 95% (2.5% confidence interval) for two gestational age groups: 13.0-14.3 and 14.4-15.6 weeks. Assuming 10% withdrawals, the investigators required 118 participants. Secondary outcomes included mechanical dilation, complications, provider satisfaction, and patient side effects and acceptability.

Official Title
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Misoprostol Dose and Timing Before Surgical Abortion at 13 to 16 Weeks' Gestation: a Randomized Trial

Conditions
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Abortion, Induced

Intervention / Treatment
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* Drug: Misoprostol 400 mcg 3 hours prior to procedure
* Drug: Misoprostol 600 mcg 90 minutes prior to procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age and older Eligible for pregnancy termination at Planned Parenthood of NYC Able to give informed consent English speaking Exclusion Criteria: Reports active bleeding, severe pain, or symptoms of spontaneous labor at enrollment Intrauterine fetal demise identified on pre-operative ultrasound Allergy to misoprostol

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 400 mcg<br>receives 400 mcg of misoprostol 3 hours prior to the procedure | Drug: Misoprostol 400 mcg 3 hours prior to procedure<br>* Misoprostol 400 mcg 3 hours prior to D&E procedure<br>|
| Experimental: 600 mcg<br>receives 600 mcg of misoprostol 90 minutes prior to the procedure | Drug: Misoprostol 600 mcg 90 minutes prior to procedure<br>* Misoprostol 600 mcg 90 minutes prior to D&E procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procedure time | Operative time defined as time from speculum in vagina to speculum out of vagina. | day of abortion procedure |