Same-day Cervical Preparation Before Dilation and Evacuation

Planned Parenthood of Greater New York

Status: Completed

Conditions: Cervical Dilation Prior to Dilation and Evacuation

Treatments: Device: Same-Day Dilapan-S; Device: Overnight Dilapan-S

Study type: Interventional

Funder types: Other

Identifiers

NCT03002441

Same Day CPrep

Details and patient eligibility

About

The purpose of this randomized trial is to compare same-day cervical preparation using Dilapan-S™ plus buccal misoprostol to overnight cervical preparation using Dilapan-S™ before D&E at 16.0 to 20.0 weeks.

Primary objective: To compare D&E operative time. We hypothesize that same-day Dilapan-S™ plus buccal misoprostol is non-inferior to overnight Dilapan-S™ with respect to operative time.

Secondary objectives: To compare treatment groups for the following: Pre-operative cervical dilation; need for mechanical dilation and ease of dilation if required; ability to complete D&E without further cervical preparation; ease of D&E; complications; pain; side effects; patient and provider satisfaction.

Enrollment: 54 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years of age and older
• Seeking pregnancy termination from 16 0/7 to 19 6/7 weeks of gestation on the day of enrollment.
• Eligible for pregnancy termination at PPNYC
• Able to give informed consent
• English speaking

Exclusion criteria

• Active bleeding or hemodynamically unstable at enrollment
• Signs of chorioamnionitis or clinical infection at enrollment
• Signs of spontaneous labor or cervical insufficiency at enrollment
• Spontaneous intrauterine fetal demise
• Allergy to Dilapan-S™ or misoprostol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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54 participants in 2 patient groups

Same-day Dilators

Active Comparator group

Description:

Participants will have Dilapan-S cervical dilators placed 4-6 hours prior to D\&E and will receive 400 mcg buccal misoprostol pills 3 hours prior to D\&E.

Treatment:

Device: Same-Day Dilapan-S

Overnight dilators

Active Comparator group

Description:

Participants will have Dilapan-S cervical dilators placed the day prior to their D\&E procedure and will receive buccal placebo pills (vitamin B12) 3 hours prior to D\&E.

Treatment:

Device: Overnight Dilapan-S