Misoprostol Versus Dilapan-S for Cervical Preparation

Cervical Ripening Clinical Trial

Official title:

Cervical Preparation Before Same-day Second Trimester Abortion With Buccal Misoprostol Versus Dilapan-S: A Randomized Placebo Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00835731
• Other study ID #: SFP2-3
• Status: Completed
• Phase: N/A
• First received: February 3, 2009
• Last updated: September 20, 2017
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: September 2017
• Source: Planned Parenthood League of Massachusetts
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Ripening

Intervention

Drug:
• misoprostol
400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E

Device:
• Dilapan-S, vitamin B-12
One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E. Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E

Locations

Country	Name	City	State
United States	Planned Parenthood League of Massachusetts	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Planned Parenthood League of Massachusetts	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical Dilation in Women Following Exposure to Either Ripening Agent		3-4 hours after placement of ripening agent
Secondary	Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report	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)	3-4 hours after placement of ripening agent
Secondary	Procedure Time for Dilation and Evacuation		3-4 hours after placement of ripening agent
Secondary	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
Secondary	Subject Pain During Ripening	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.	3-4 hours after placement of ripening agent
Secondary	Subject Pain During Dilation and Evacuation	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.	3-4 hours after placement of ripening agent
Secondary	Women's Satisfaction With Cervical Ripening Method	Scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied	5 hours after placement of ripening agent