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Same-day Cervical Preparation Before Dilation and Evacuation

Primary Purpose

Cervical Dilation Prior to Dilation and Evacuation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Same-Day Dilapan-S
Overnight Dilapan-S
Sponsored by
Planned Parenthood of Greater New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Dilation Prior to Dilation and Evacuation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • Planned Parenthood of Greater New York

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Same-day Dilators

Overnight dilators

Arm 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.

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.

Outcomes

Primary Outcome Measures

Operative time

Secondary Outcome Measures

Full Information

First Posted
December 6, 2016
Last Updated
April 21, 2021
Sponsor
Planned Parenthood of Greater New York
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1. Study Identification

Unique Protocol Identification Number
NCT03002441
Brief Title
Same-day Cervical Preparation Before Dilation and Evacuation
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Planned Parenthood of Greater New York

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dilation Prior to Dilation and Evacuation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Same-day Dilators
Arm Type
Active Comparator
Arm 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.
Arm Title
Overnight dilators
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Same-Day Dilapan-S
Intervention Description
Dilapan-S cervical dilators placed the same day as the D&E procedure
Intervention Type
Device
Intervention Name(s)
Overnight Dilapan-S
Intervention Description
Dilapan-S cervical dilators placed the day prior to D&E procedure
Primary Outcome Measure Information:
Title
Operative time
Time Frame
From initiation of D&E procedure to completion of D&E procedure, Study Day 2

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ila Dayananda
Organizational Affiliation
Planned Parenthood of Greater New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Planned Parenthood of Greater New York
City
New York
State/Province
New York
ZIP/Postal Code
10012
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35675611
Citation
Kim CS, Dragoman M, Porsch L, Markowitz J, Lunde B, Stoffels G, Dayananda I. Same-Day Compared With Overnight Cervical Preparation Before Dilation and Evacuation Between 16 and 19 6/7 Weeks of Gestation: A Randomized Controlled Trial. Obstet Gynecol. 2022 Jun 1;139(6):1141-1144. doi: 10.1097/AOG.0000000000004790. Epub 2022 May 2. Erratum In: Obstet Gynecol. 2022 Aug 1;140(2):344-345.
Results Reference
derived

Learn more about this trial

Same-day Cervical Preparation Before Dilation and Evacuation

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