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Dilapan Versus Laminaria

Not Applicable
Completed
Conditions
Cervical Preparation
Interventions
Device: Dilapan-S
Device: laminaria
Registration Number
NCT00775983
Lead Sponsor
University of California, San Francisco
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
72
Inclusion Criteria
  • Pregnancy between fourteen and eighteen weeks gestation
  • Request for elective abortion and certainty of decision to proceed
Read More
Exclusion Criteria
  • Incarceration
  • Minor status (women younger than eighteen years)
  • Allergy to Dilapan or laminaria
  • Inability to speak and understand Spanish or English
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Dilapan-SDilapan-Sexperimental treatment
laminarialaminarialaminaria placed for cervical dilation; usual standard of care in study clinic
Primary Outcome Measures
NameTimeMethod
Procedure TimeDay of procedure

Procedure time to complete early second-trimester dilation and evacuation (D\&E)

Secondary Outcome Measures
NameTimeMethod
Participants Who Experienced Complications or Need for Additional DilationDay of procedure

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

Trial Locations

Locations (1)

San Francisco General Hospital

🇺🇸

San Francisco, California, United States

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