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

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ClinicalTrials.gov Identifier: NCT02033083
Recruitment Status : Completed
First Posted : January 10, 2014
Results First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Planned Parenthood of New York City, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Second Trimester Abortion
Interventions Device: Laminaria
Device: Dilapan-S
Enrollment 180
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Laminaria Dilapan-S
Hide Arm/Group Description

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

Laminaria

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

Dilapan-S

Period Title: Overall Study
Started 89 89
Completed 88 88
Not Completed 1 1
Arm/Group Title Laminaria Dilapan-S Total
Hide Arm/Group Description

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

Laminaria

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

Dilapan-S

Total of all reporting groups
Overall Number of Baseline Participants 89 89 178
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 89 participants 89 participants 178 participants
23.99  (4.49) 23.80  (4.61) 23.90  (4.55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 89 participants 178 participants
Female
89
 100.0%
89
 100.0%
178
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 89 participants 178 participants
African-American or Black
42
  47.2%
45
  50.6%
87
  48.9%
Hispanic or Latina
21
  23.6%
18
  20.2%
39
  21.9%
White
8
   9.0%
16
  18.0%
24
  13.5%
Other
18
  20.2%
10
  11.2%
28
  15.7%
1.Primary Outcome
Title D&E Procedure Time
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Laminaria Dilapan-S
Hide Arm/Group Description:

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

Laminaria

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

Dilapan-S

Overall Number of Participants Analyzed 88 88
Mean (Standard Deviation)
Unit of Measure: minutes
7.35  (3.63) 7.55  (4.59)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Laminaria Dilapan-S
Hide Arm/Group Description

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

Laminaria

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

Dilapan-S

All-Cause Mortality
Laminaria Dilapan-S
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Laminaria Dilapan-S
Affected / at Risk (%) Affected / at Risk (%)
Total   0/89 (0.00%)   0/89 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Laminaria Dilapan-S
Affected / at Risk (%) Affected / at Risk (%)
Total   0/89 (0.00%)   0/89 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Training and Research
Organization: Planned Parenthood of New York City
Phone: 212-274-7340
EMail: ctri@ppnyc.org
Layout table for additonal information
Responsible Party: Planned Parenthood of New York City, Inc.
ClinicalTrials.gov Identifier: NCT02033083     History of Changes
Other Study ID Numbers: laminariavsdilapan
First Submitted: January 8, 2014
First Posted: January 10, 2014
Results First Submitted: August 13, 2018
Results First Posted: September 12, 2018
Last Update Posted: September 12, 2018