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

Primary Purpose

Second Trimester Abortion

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Laminaria

Dilapan-S

About this trial

This is an interventional treatment trial for Second Trimester Abortion focused on measuring abortion, cervical dilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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™

Sites / Locations

Planned Parenthood of New York City

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Laminaria

Dilapan-S

Arm Description

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

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

Outcomes

Primary Outcome Measures

D&E Procedure Time

Length of D&E procedure in minutes

Secondary Outcome Measures

Full Information

NCT ID

NCT02033083

First Posted

January 8, 2014

Last Updated

June 20, 2021

Sponsor

Planned Parenthood of Greater New York

Collaborators

Society of Family Planning

1. Study Identification

Unique Protocol Identification Number

NCT02033083

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

December 2013 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Planned Parenthood of Greater New York

Collaborators

Society of Family Planning

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Second Trimester Abortion

Keywords

abortion, cervical dilation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

180 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Laminaria

Arm Type

Active Comparator

Arm Description

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

Arm Title

Dilapan-S

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Laminaria

Intervention Type

Device

Intervention Name(s)

Dilapan-S

Primary Outcome Measure Information:

Title

D&E Procedure Time

Description

Length of D&E procedure in minutes

Time Frame

The primary outcome measure will be assessed on the day of the patient's D&E procedure. (day 2)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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™

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Principal Investigator

Organizational Affiliation

Planned Parenthood of New York City

Official's Role

Principal Investigator

Facility Information:

Facility Name

Planned Parenthood of New York City

City

New York

State/Province

New York

ZIP/Postal Code

10012

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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