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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Second Trimester Abortion

Intervention / Treatment
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* Device: Laminaria
* Device: Dilapan-S


Participation Criteria
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Eligibility Criteria
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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™

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laminaria<br>Patients in this arm will receive laminaria cervical dilators one day before D&E procedure. | Device: Laminaria<br> <br> |
| Active Comparator: Dilapan-S<br>Patients in this arm will receive Dilapan-S cervical dilators one day before D&E procedure. | Device: Dilapan-S<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abortion, cervical dilation