Laminaria Compared to Dilapan-S for Cervical Preparation Before Dilation and Evacuation at 18-24 Weeks of Gestation

June 20, 2021 updated by: Planned Parenthood of Greater New York

Laminaria Compared to Dilapan-S for Cervical Preparation Before Dilation and Evacuation at 18-24 Weeks of Gestation: A Randomized Controlled Trial

Primary objective: To study the difference in dilation and evacuation (D&E) procedure time following overnight cervical preparation with laminaria or Dilapan-S™. The investigators hypothesize procedure time will be less with Dilapan-S™.

Secondary objectives: To compare the use of laminaria and Dilapan-S™ for differences in: (1) initial cervical dilation before D&E; (2) need for mechanical dilation to accomplish D&E and ease of dilation if required; (3) number of osmotic dilators placed; (4) ability to complete the D&E procedure without further cervical preparation; (5) complications; (6) pain and other side effects; (7) patient acceptability; and (8) provider acceptability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One hundred eighty women were randomized evenly across treatment arms, stratified by gestational age groups of 18 0/7-20 6/7 (n= 91) and 21 0/7-24 0/7 (n=87). The analytic sample N=173 (laminaria=86, Dilapan=87); 2 cases were removed for post-randomization exclusion and 5 for missing data on one or more outcome variables. Demographic information and results for the primary outcome of procedure time are reported below in tabular form in the results section.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10012
        • Planned Parenthood of New York City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 18 years of age and older
  • Seeking pregnancy termination from 18 0/7 to 24 0/7 weeks of gestation
  • Eligible for pregnancy termination at Planned Parenthood of New York City
  • 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 laminaria or Dilapan-S™

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Laminaria
Patients in this arm will receive laminaria cervical dilators one day before D&E procedure.
Device: Laminaria
Active Comparator: Dilapan-S
Patients in this arm will receive Dilapan-S cervical dilators one day before D&E procedure.
Device: Dilapan-S

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
D&E Procedure Time
Time Frame: The primary outcome measure will be assessed on the day of the patient's D&E procedure. (day 2)
Length of D&E procedure in minutes
The primary outcome measure will be assessed on the day of the patient's D&E procedure. (day 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Planned Parenthood of Greater New York

Collaborators

Society of Family Planning

Investigators

  • Principal Investigator: Principal Investigator, Planned Parenthood of New York City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

January 8, 2014

First Submitted That Met QC Criteria

January 9, 2014

First Posted (Estimate)

January 10, 2014

Study Record Updates

Last Update Posted (Actual)

July 12, 2021

Last Update Submitted That Met QC Criteria

June 20, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • laminariavsdilapan

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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