Misoprostol Versus Dilapan-S for Cervical Preparation

Study Overview
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Brief Summary
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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.

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

Conditions
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Cervical Ripening

Intervention / Treatment
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* Drug: misoprostol
* Device: Dilapan-S, vitamin B-12


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>400mcg buccal misoprostol | Drug: misoprostol<br>* 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E<br>* Other names: Cytotec;|
| Experimental: 2<br>Dilapan-S, control: vitamin B-12 administered sublingually | Device: Dilapan-S, vitamin B-12<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical Dilation in Women Following Exposure to Either Ripening Agent |  | 3-4 hours after placement of ripening agent | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Procedure Time for Dilation and Evacuation |  | 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 |  | 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. | 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. | 3-4 hours after placement of ripening agent | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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induced abortion, misoprostol, cervical ripening, second trimester abortion, Dilapan-S