Dilapan Versus Laminaria (DvL)
Status
Conditions
Treatments
Details and patient eligibility
About
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
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
72 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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