Clinical Trials Directory

Trials / Completed

CompletedNCT00775983

Dilapan Versus Laminaria

Same-day Dilapan Versus Overnight Laminaria for Cervical Preparation for Early Second-trimester Surgical Abortion

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
72 (actual)
Sponsor
University of California, San Francisco · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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

Conditions

Interventions

TypeNameDescription
DEVICElaminariaplace device in cervix for dilation
DEVICEDilapan-SPlace in cervix for dilation.

Timeline

Start date
2008-10-01
Primary completion
2009-12-01
Completion
2009-12-01
First posted
2008-10-20
Last updated
2013-11-14
Results posted
2013-07-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00775983. Inclusion in this directory is not an endorsement.