Dilapan Versus Laminiaria - Full Text View

Sponsored by:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00775983

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Bio-equivalence Study
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:

determine differences in procedure times [ Time Frame: after last subject has completed the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: assessed after final subject has completed study ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
laminaria: Active Comparator laminaria placed for cervical dilation; usual standard of care in study clinic	Device: laminaria place device in cervix for dilation
Dilapan-S: Experimental 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

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

Contacts

Contact: Abby Sokoloff, MPH	415-514-0440	sokoloffa@obgyn.ucsf.edu
Contact: Sarah Newmann, MD, MPH	415-206-4220	newmanns@obgyn.ucsf.edu

Locations

United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110

Sponsors and Collaborators

University of California, San Francisco

More Information

Responsible Party:	University of California, San Francisco ( Eleanor Drey, MD, EdM/ )
Study ID Numbers:	1176030877
Study First Received:	October 16, 2008
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00775983
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on January 16, 2009