Same-day Cervical Preparation Before Dilation and Evacuation



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:8/16/2018
Start Date:December 2016
End Date:December 2019
Contact:Research Director, MPH
Email:ctri@ppnyc.org

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Trial Summary
Trial Overview
Inclusion Criteria

Same-day Cervical Preparation With Dilapan-S™ Plus Buccal Misoprostol Compared to Overnight Dilapan-S™ Before Dilation and Evacuation at 16 to 20 Weeks' Gestation: A Randomized Controlled Trial

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.


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
We found this trial at
1
site
Planned Parenthood of New York City - Margaret Sanger Center
New York, New York 10012
?
mi
from
New York, NY
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