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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.

Tracking Information
First Submitted Date  ICMJE January 8, 2014
First Posted Date  ICMJE January 10, 2014
Results First Submitted Date  ICMJE August 13, 2018
Results First Posted Date  ICMJE September 12, 2018
Last Update Posted Date September 12, 2018
Study Start Date  ICMJE December 2013
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 9, 2014)
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) ]
Change History Complete list of historical versions of study NCT02033083 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laminaria Compared to Dilapan-S for Cervical Preparation Before Dilation and Evacuation at 18-24 Weeks of Gestation
Official Title  ICMJE Laminaria Compared to Dilapan-S for Cervical Preparation Before Dilation and Evacuation at 18-24 Weeks of Gestation: A Randomized Controlled Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Second Trimester Abortion
Intervention  ICMJE
  • Device: Laminaria
  • Device: Dilapan-S
Study Arms  ICMJE
  • Active Comparator: Laminaria
    Patients in this arm will receive laminaria cervical dilators one day before D&E procedure.
    Intervention: Device: Laminaria
  • Active Comparator: Dilapan-S
    Patients in this arm will receive Dilapan-S cervical dilators one day before D&E procedure.
    Intervention: Device: Dilapan-S
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2014)
180
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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™
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02033083
Other Study ID Numbers  ICMJE laminariavsdilapan
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Planned Parenthood of New York City, Inc.
Study Sponsor  ICMJE Planned Parenthood of New York City, Inc.
Collaborators  ICMJE Society of Family Planning
Investigators  ICMJE
Principal Investigator: Principal Investigator Planned Parenthood of New York City
PRS Account Planned Parenthood of New York City, Inc.
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP