Dilapan Versus Laminaria — DvL  

Cervical Preparation Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Preparation

• NCT number: NCT00775983
• Study type: Interventional
• Source: University of California, San Francisco
• Status: Completed
• Phase: N/A
• Start date: October 2008
• Completion date: December 2009