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

Second Trimester Abortion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02033083
• Other study ID #: laminariavsdilapan
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: February 2016

Study information

• Verified date: June 2021
• Source: Planned Parenthood of Greater New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

One hundred eighty women were randomized evenly across treatment arms, stratified by gestational age groups of 18 0/7-20 6/7 (n= 91) and 21 0/7-24 0/7 (n=87). The analytic sample N=173 (laminaria=86, Dilapan=87); 2 cases were removed for post-randomization exclusion and 5 for missing data on one or more outcome variables. Demographic information and results for the primary outcome of procedure time are reported below in tabular form in the results section.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• • 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™

Related Conditions & MeSH terms

• Second Trimester Abortion

Intervention

Device:
• Laminaria

• Dilapan-S

Locations

Country	Name	City	State
United States	Planned Parenthood of New York City	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Planned Parenthood of Greater New York	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	D&E Procedure Time	Length of D&E procedure in minutes	The primary outcome measure will be assessed on the day of the patient's D&E procedure. (day 2)