- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02363556
Comparing Misoprostol Alone to Dilapan With Misoprostol and Comparing Buccal to Vaginal Misoprostol
A Factorial-Design Randomized Controlled Trial Comparing Misoprostol Alone to Dilapan With Misoprostol and Comparing Buccal to Vaginal Misoprostol for Same-Day Cervical Preparation Prior to Dilation & Evacuation
Study Overview
Status
Conditions
Detailed Description
The primary objective of the study is to compare the efficacy of same-day 400-mcg misoprostol alone to same-day Dilapan with 400-mcg misoprostol for cervical preparation prior to D&E at 14 0/7 to 19 6/7 weeks. Patients will first be randomized to misoprostol alone or misoprostol-Dilapan, and then separately randomized to use the misoprostol buccally or vaginally.
The primary outcome measure is total procedure time. Secondary outcomes include D&E procedure time, initial cervical dilation (measured by the largest Hegar dilator accepted without resistance prior to the start of the procedure), patient-oriented outcomes (side effects of buccal and vaginal misoprostol), and patient acceptability and satisfaction.
The investigators have chosen a randomized controlled trial with a factorial design to be conducted at Washington Hospital Center and Planned Parenthood of Metropolitan Washington. A total up to 180 English speaking women will be enrolled in the study so that 160 will be randomized and receive study interventions. The study will enroll healthy women, over the age of 18, eligible for non-urgent D&E at 14 0/7 weeks to 19 6/7 weeks, confirmed by sonogram. The women will be randomized to receive either misoprostol alone or Dilapan with misoprostol. Women will then be randomized to receive 400-mcg of misoprostol either buccally or vaginally. Computer generated randomization will be utilized to assign treatment arms. Approximately 4-6 hours prior to procedure, women will be randomly assigned to one of the following treatment combinations:
- Misoprostol 400-mcg vaginally
- Misoprostol 400-mcg buccally
- Dilapan insertion with 400-mcg misoprostol vaginally
- Dilapan insertion with 400-mcg misoprostol buccally
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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District of Columbia
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Washington, D.C., District of Columbia, United States, 20010
- MedStar Washington Hospital Center
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Maryland
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Silver Spring, Maryland, United States, 20910
- Planned Parenthood Metropolitan Washington
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy pregnant women
- 18 years of age or older
- Eligible for non-urgent Dilation and Evacuations at 14 0/7 - 19 6/7 weeks gestation confirmed by sonogram.
Exclusion Criteria:
- Women who do not speak English.
- Fetal demise
- Intolerance, allergy or contraindication to misoprostol or Dilapan.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Misoprostol Alone
Subjects enrolled into this arm of the study will receive misoprostol 400-mcg only.
|
|
Experimental: Dilapan with Misoprostol
Subjects enrolled into this arm of the study will receive Dilapan with 400-mcg misoprostol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total procedure time
Time Frame: 4-6hrs
|
Total procedure time is defined as the time required for dilator insertion plus the D&E time.
|
4-6hrs
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
D&E procedure time
Time Frame: 0-60 mins
|
0-60 mins
|
|
Initial cervical dilation
Time Frame: 0-10 mins
|
Measured by the largest Hegar dilator accepted without resistance prior to the start of the procedure.
|
0-10 mins
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Dr. Matthew Reeves, MD MPH, MedStar Washington Hospital Center & Planned Parenthood of Metropolitan Washington
- Study Chair: Dr. Jamilah Shakir, MD MPH, MedStar Washington Hospital Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-110
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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