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Same-day Cervical Preparation Before Dilation and Evacuation

NCT03002441 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2021-04-22

No results posted yet for this study

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.

Conditions

  • Cervical Dilation Prior to Dilation and Evacuation

Interventions

DEVICE

Same-Day Dilapan-S

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

DEVICE

Overnight Dilapan-S

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

Sponsors & Collaborators

  • Planned Parenthood of Greater New York

    lead OTHER

Principal Investigators

  • Ila Dayananda · Planned Parenthood of Greater New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2019-12-31
Completion
2020-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03002441 on ClinicalTrials.gov