Same-day Cervical Preparation Before Dilation and Evacuation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2020-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Misoprostol Versus Dilapan-S for Cervical Preparation

NCT00835731

Cervical Ripening

COMPLETED NA

Same-day Dilapan-S With Adjunctive Misoprostol

NCT01818414

Therapeutic Abortion

TERMINATED NA

Comparing Misoprostol Alone to Dilapan With Misoprostol and Comparing Buccal to Vaginal Misoprostol

NCT02363556

Second Trimester Abortions

COMPLETED NA

24-hour Mifepristone and Buccal Versus Mifepristone and Vaginal Misoprostol for Cervical Preparation for D&E

NCT03134183

Abortion, Second Trimester

COMPLETED PHASE4

Comparison of Misoprostol Ripening Efficacy With Dilapan

NCT03670836

Labor Onset and Length Abnormalities Induced; Birth

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Dilation Prior to Dilation and Evacuation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Same-day Dilators

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.

Group Type ACTIVE_COMPARATOR

Same-Day Dilapan-S

Intervention Type DEVICE

Dilapan-S cervical dilators placed the same day as the D\&E procedure

Overnight dilators

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.

Group Type ACTIVE_COMPARATOR

Overnight Dilapan-S

Intervention Type DEVICE

Dilapan-S cervical dilators placed the day prior to D\&E procedure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Same-Day Dilapan-S

Dilapan-S cervical dilators placed the same day as the D\&E procedure

Intervention Type DEVICE

Overnight Dilapan-S

Dilapan-S cervical dilators placed the day prior to D\&E procedure

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes