CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 180 enrolled
Drug / intervention
Laminaria +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02033083
NCT02033083N/ACompleted

Laminaria Compared to Dilapan-S for Cervical Preparation Before Dilation and Evacuation at 18-24 Weeks of Gestation: A Randomized Controlled Trial

Planned Parenthood of Greater New York·interventional·Posted Jan 10, 2014·Updated Jul 12, 2021

In Brief

A clinical study evaluating Laminaria and Dilapan-S for Second Trimester Abortion. Completed, enrolled 180 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 10, 2014
Enrollment StartDec 1, 2013
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 12.5 years ago

Interventions

Laminariadevice

Dilapan-Sdevice