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OpenTrials
Completed

NCT Number: NCT02033083

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

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.

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Key information

Conditions

Second Trimester Abortion

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Planned Parenthood of New York City

New York, 10012, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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™

Treatment and study plan

laminaria

Device

Dilapan-S

Device

Primary outcomes

  1. D&E Procedure Time

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Planned Parenthood of Greater New York

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 10, 2014
Registry last updated
Jul 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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