N/A N=72 Randomized Triple-blind Treatment

Dilapan Versus Laminaria

Cervical Preparation

Bottom Line

View on ClinicalTrials.gov: NCT00775983 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2013

Primary outcome: Primary: Procedure Time — 5.9; 8.1 minutes

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: laminaria (Device); Dilapan-S (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of California, San Francisco
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Procedure Time	5.9; 8.1	—
SECONDARY Participants Who Experienced Complications or Need for Additional Dilation	10; 7; 2; 3; 1; 0	—

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00775983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.