N/A
N=125
Misoprostol Versus Dilapan-S for Cervical Preparation
Cervical Ripening
Bottom Line
View on ClinicalTrials.gov: NCT00835731 ↗Enrolled (actual)
125
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Cervical Dilation in Women Following Exposure to Either Ripening Agent — 32.1; 33.9 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- misoprostol (Drug); Dilapan-S, vitamin B-12 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Planned Parenthood League of Massachusetts
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cervical Dilation in Women Following Exposure to Either Ripening Agent |
32.1; 33.9 | — |
| SECONDARY Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report |
3; 3; 29; 27; 12; 24 | — |
| SECONDARY Procedure Time for Dilation and Evacuation |
2.8; 3.0 | — |
| SECONDARY Number of Patients for Whom Physician Was Able to Complete Dilation and Evacuation Procedure on First Attempt |
62; 60 | — |
| SECONDARY Subject Pain During Ripening |
1; 1 | — |
| SECONDARY Subject Pain During Dilation and Evacuation |
3; 3 | — |
| SECONDARY Women's Satisfaction With Cervical Ripening Method |
4; 4 | — |
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 who are 12 weeks 0 days to 15 weeks 0 days gestation.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00835731). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.