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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
125
400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D\&E
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
Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States
Cervical Dilation in Women Following Exposure to Either Ripening Agent
Time frame: 3-4 hours after placement of ripening agent
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)
Time frame: 3-4 hours after placement of ripening agent
Procedure Time for Dilation and Evacuation
Time frame: 3-4 hours after placement of ripening agent
Number of Patients for Whom Physician Was Able to Complete Dilation and Evacuation Procedure on First Attempt
Time frame: 3-4 hours after placement of ripening agent
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.
Time frame: 3-4 hours after placement of ripening agent
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.
Time frame: 3-4 hours after placement of ripening agent
Women's Satisfaction With Cervical Ripening Method
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Scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied
Time frame: 5 hours after placement of ripening agent