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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2016-02-29

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.

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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.

Conditions

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Second Trimester Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Laminaria

Patients in this arm will receive laminaria cervical dilators one day before D\&E procedure.

Group Type ACTIVE_COMPARATOR

Laminaria

Intervention Type DEVICE

Dilapan-S

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

Group Type ACTIVE_COMPARATOR

Dilapan-S

Intervention Type DEVICE

Interventions

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Laminaria

Intervention Type DEVICE

Dilapan-S

Intervention Type DEVICE

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™

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes