Dilapan Versus Laminaria (DvL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eleanor Drey, MD, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00775983
First received: October 16, 2008
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

This is a randomized, blinded clinical trial comparing overnight laminaria versus same-day Dilapan for cervical preparation for surgical abortions occurring between fourteen and eighteen weeks gestation. Comparisons will be made between procedure time, need for additional dilation, occurrence of complications, and patient and provider satisfaction.

Hypothesis:

Cervical preparation for surgical abortion, between fourteen and eighteen weeks gestation, with same-day Dilapan is non-inferior to cervical preparation with overnight laminaria within a five-minute difference.

Primary objective:

Determine differences in procedure times

Secondary objectives:

Examine complications, and need for additional dilation between early second-trimester surgical abortions performed after cervical preparation with same-day Dilapan versus those performed after cervical preparation with overnight laminaria


Condition Intervention
Cervical Preparation
Device: laminaria
Device: Dilapan-S

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Same-day Dilapan Versus Overnight Laminaria for Cervical Preparation for Early Second-trimester Surgical Abortion

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Procedure Time [ Time Frame: Day of procedure ] [ Designated as safety issue: No ]
    Procedure time to complete early second-trimester dilation and evacuation (D&E)


Secondary Outcome Measures:
  • Participants Who Experienced Complications or Need for Additional Dilation [ Time Frame: Day of procedure ] [ Designated as safety issue: No ]
    Any complications, or mechanical dilation required, for early second-trimester surgical abortions performed after cervical preparation with same-day Dilapan versus those performed after cervical preparation with overnight laminaria


Enrollment: 72
Study Start Date: October 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: laminaria
laminaria placed for cervical dilation; usual standard of care in study clinic
Device: laminaria
place device in cervix for dilation
Experimental: Dilapan-S
experimental treatment
Device: Dilapan-S
Place in cervix for dilation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnancy between fourteen and eighteen weeks gestation
  • Request for elective abortion and certainty of decision to proceed

Exclusion Criteria:

  • Incarceration
  • Minor status (women younger than eighteen years)
  • Allergy to Dilapan or laminaria
  • Inability to speak and understand Spanish or English
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775983

Locations
United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
  More Information

No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eleanor Drey, MD, Associate Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00775983     History of Changes
Other Study ID Numbers: 1176030877
Study First Received: October 16, 2008
Results First Received: May 7, 2013
Last Updated: October 18, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 29, 2014