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

Completed · Not applicable

Conditions studied: Second Trimester Abortion

In brief

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.

Key facts

Study ID

NCT02033083

Run by

Planned Parenthood of Greater New York

People needed

180

Starts

2013-12-01

Expected to finish

2016-02-01

Last updated by the study team

2021-07-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 18 years of age and older
• Seeking pregnancy termination from 18 0/7 to 24 0/7 weeks of gestation
• Eligible for pregnancy termination at Planned Parenthood of New York City
• Able to give informed consent
• English speaking

You may not qualify if…

• • Active bleeding or hemodynamically unstable at enrollment
• Signs of chorioamnionitis or clinical infection at enrollment
• Signs of spontaneous labor or cervical insufficiency at enrollment
• Spontaneous intrauterine fetal demise
• Allergy to laminaria or Dilapan-S™

Where it is running

• Planned Parenthood of New York City — New York, New York, United States

Full record on ClinicalTrials.gov

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