Misoprostol Versus Dilapan-S for Cervical Preparation

Planned Parenthood League of Massachusetts

Status: Completed

Conditions: Cervical Ripening

Treatments: Drug: misoprostol; Device: Dilapan-S, vitamin B-12

Study type: Interventional

Funder types: Other

Identifiers

NCT00835731

SFP2-3

Details and patient eligibility

About

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.

Enrollment: 125 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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125 participants in 2 patient groups

1

Experimental group

Description:

400mcg buccal misoprostol

Treatment:

Drug: misoprostol

2

Experimental group

Description:

Dilapan-S, control: vitamin B-12 administered sublingually

Treatment:

Device: Dilapan-S, vitamin B-12