Same-day Cervical Preparation Before Dilation and Evacuation

NCT03002441 | Completed

• 1 other identifier: Same Day CPrep
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Dilation Prior to Dilation and Evacuation

Outcome Measures

Primary Outcomes (1)

• Operative time

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

Study Arms (2)

Same-day Dilators

ACTIVE COMPARATOR

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.

Device: Same-Day Dilapan-S

Overnight dilators

ACTIVE COMPARATOR

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.

Device: Overnight Dilapan-S

Interventions

Same-Day Dilapan-S DEVICE

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

Same-day Dilators

Overnight Dilapan-S DEVICE

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

Overnight dilators

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Planned Parenthood of Greater New York: lead

Study Sites (1)

Planned Parenthood of Greater New York

New York, New York, 10012, United States

Location

Related Publications (1)

• 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.

  PMID: 35675611 DERIVED

Study Officials

• Ila Dayananda

  Planned Parenthood of Greater New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 23, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: February 28, 2020
• Last Updated: April 22, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)