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

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ClinicalTrials.gov Identifier: NCT02033083
Recruitment Status : Completed
First Posted : January 10, 2014
Results First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Planned Parenthood of New York City, Inc.

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Second Trimester Abortion Device: Laminaria Device: Dilapan-S Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Laminaria Compared to Dilapan-S for Cervical Preparation Before Dilation and Evacuation at 18-24 Weeks of Gestation: A Randomized Controlled Trial
Study Start Date : December 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

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



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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™

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033083


Locations
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United States, New York
Planned Parenthood of New York City
New York, New York, United States, 10012
Sponsors and Collaborators
Planned Parenthood of New York City, Inc.
Society of Family Planning
Investigators
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Principal Investigator: Principal Investigator Planned Parenthood of New York City

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Responsible Party: Planned Parenthood of New York City, Inc.
ClinicalTrials.gov Identifier: NCT02033083     History of Changes
Other Study ID Numbers: laminariavsdilapan
First Posted: January 10, 2014    Key Record Dates
Results First Posted: September 12, 2018
Last Update Posted: September 12, 2018
Last Verified: August 2018
Keywords provided by Planned Parenthood of New York City, Inc.:
abortion
cervical dilation
Additional relevant MeSH terms:
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Dilatation, Pathologic
Pathological Conditions, Anatomical