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

Not Applicable

Completed

• Conditions: Second Trimester Abortion
• Interventions: Device: Laminaria; Device: Dilapan-S

• Registration Number: NCT02033083
• Lead Sponsor: Planned Parenthood of Greater New York

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2014-01-09
• Study First Posted: 2014-01-10
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Results First Submitted: 2018-08-13
• Results First Submitted QC: 2018-08-13
• Results First Posted: 2018-09-12
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-20
• Last Update Posted: 2021-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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™

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laminaria	Laminaria	Patients in this arm will receive laminaria cervical dilators one day before D\&E procedure.
Dilapan-S	Dilapan-S	Patients in this arm will receive Dilapan-S cervical dilators one day before D\&E procedure.

Primary Outcome Measures

Name	Time	Method
D&E Procedure Time	The primary outcome measure will be assessed on the day of the patient's D&E procedure. (day 2)	Length of D\&E procedure in minutes

Trial Locations

Locations (1)

Planned Parenthood of New York City; 🇺🇸 New York, New York, United States