Dilapan Versus Laminaria
- Conditions
- Cervical Preparation
- Interventions
- Device: Dilapan-SDevice: 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
- Pregnancy between fourteen and eighteen weeks gestation
- Request for elective abortion and certainty of decision to proceed
- Incarceration
- Minor status (women younger than eighteen years)
- Allergy to Dilapan or laminaria
- Inability to speak and understand Spanish or English
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dilapan-S Dilapan-S experimental treatment laminaria laminaria laminaria placed for cervical dilation; usual standard of care in study clinic
- Primary Outcome Measures
Name Time Method Procedure Time Day of procedure Procedure time to complete early second-trimester dilation and evacuation (D\&E)
- Secondary Outcome Measures
Name Time Method Participants Who Experienced Complications or Need for Additional Dilation Day 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