Misoprostol Versus Dilapan-S for Cervical Preparation

Not Applicable

Completed

• Conditions: Cervical Ripening
• Interventions: Device: Dilapan-S, vitamin B-12; Drug: misoprostol

• Registration Number: NCT00835731
• Lead Sponsor: Planned Parenthood League of Massachusetts

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 who are 12 weeks 0 days to 15 weeks 0 days gestation.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-02-03
• Study First Submitted QC: 2009-02-03
• Study First Posted: 2009-02-04
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2013-06-13
• Results First Submitted QC: 2013-11-20
• Results First Posted: 2014-01-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-20
• Last Update Posted: 2017-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Dilapan-S, vitamin B-12	Dilapan-S, control: vitamin B-12 administered sublingually
1	misoprostol	400mcg buccal misoprostol

Primary Outcome Measures

Name	Time	Method
Cervical Dilation in Women Following Exposure to Either Ripening Agent	3-4 hours after placement of ripening agent

Secondary Outcome Measures

Name	Time	Method
Procedure Time for Dilation and Evacuation	3-4 hours after placement of ripening agent
Subject Pain During Ripening	3-4 hours after placement of ripening agent	Measure assesses patient pain during cervical preparation. Pain was assessed after cervical ripening was complete, immediately before D\&E procedure. Subjects were asked to rate pain on a 6 point Likert scale: 0 = no pain 1-2 = mild pain 3 = moderate pain 4-5 = severe pain; Higher values represent a worse outcome.
Women's Satisfaction With Cervical Ripening Method	5 hours after placement of ripening agent	Scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied
Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report	3-4 hours after placement of ripening agent	Scale: None needed (score of 0) Very easy (score 1) Somewhat easy (score of 2) Moderate (score of 3) Somewhat difficult (score of 4) Very difficult (score of 5)
Subject Pain During Dilation and Evacuation	3-4 hours after placement of ripening agent	Measure assesses subject pain during dilation and evacuation. Pain was assessed immediately after the D\&E procedure. Subjects were asked to rate pain on a 6 point Likert scale: 0 = no pain 1-2 = mild pain 3 = moderate pain 4-5 = severe pain; Higher values represent a worse outcome.
Number of Patients for Whom Physician Was Able to Complete Dilation and Evacuation Procedure on First Attempt	3-4 hours after placement of ripening agent

Trial Locations

Locations (1)

Planned Parenthood League of Massachusetts; 🇺🇸 Boston, Massachusetts, United States