CompletedNot Applicable

Same-day Cervical Preparation Before Dilation and Evacuation

United States54 participantsStarted 2016-12

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Operative time

Timeframe: From initiation of D&E procedure to completion of D&E procedure, Study Day 2

Trial details

NCT IDNCT03002441

SponsorPlanned Parenthood of Greater New York

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

View on ClinicalTrials.gov More Cervical Dilation Prior to Dilation and Evacuation trials