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Dilapan Versus Laminaria

NCT00775983 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2013-11-14

Study results available
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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

  • Cervical Preparation

Interventions

DEVICE

laminaria

place device in cervix for dilation

DEVICE

Dilapan-S

Place in cervix for dilation.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00775983 on ClinicalTrials.gov