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Laminaria Compared to Dilapan-S for Cervical Preparation Before Dilation and Evacuation at 18-24 Weeks of Gestation

NCT02033083 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2021-07-12

Study results available
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Summary

Primary objective: To study the difference in dilation and evacuation (D\&E) procedure time following overnight cervical preparation with laminaria or Dilapan-S™. The investigators hypothesize procedure time will be less with Dilapan-S™.

Secondary objectives: To compare the use of laminaria and Dilapan-S™ for differences in: (1) initial cervical dilation before D\&E; (2) need for mechanical dilation to accomplish D\&E and ease of dilation if required; (3) number of osmotic dilators placed; (4) ability to complete the D\&E procedure without further cervical preparation; (5) complications; (6) pain and other side effects; (7) patient acceptability; and (8) provider acceptability.

Conditions

  • Second Trimester Abortion

Interventions

DEVICE

Laminaria

DEVICE

Dilapan-S

Sponsors & Collaborators

Principal Investigators

  • Principal Investigator · Planned Parenthood of New York City

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

Study Locations

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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 NCT02033083 on ClinicalTrials.gov