Status:
COMPLETED
Misoprostol Versus Dilapan-S for Cervical Preparation
Lead Sponsor:
Planned Parenthood League of Massachusetts
Collaborating Sponsors:
Society of Family Planning
Conditions:
Cervical Ripening
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare the dilatory effect of 400 mcg of buccally administered misoprostol to one Dilapan-S rod placed 3-4 hours before abortion by dilation and evacuation in women wh...
Eligibility Criteria
Inclusion
- medically eligible for dilation and evacuation at Planned Parenthood League of Massachusetts
- gestational age 12 weeks 0 days to 15 weeks 0 days as evaluated by ultrasound
- proficient in English or Spanish
- agreeing to study procedures, including randomization and surveys regarding demographics, medical and gynecological history, and assessments of pain and satisfaction
Exclusion
- less than 18 years old
- cervical or uterine anomaly that the research physician deems may affect the difficulty of dilation or the abortion procedure
- inflammatory bowel disease
- contraindication to misoprostol use
- known intolerance or allergy to misoprostol or Dilapan-S
- inability to give informed consent
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00835731
Start Date
January 1 2009
End Date
December 1 2011
Last Update
October 23 2017
Active Locations (1)
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1
Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States, 02215