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
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.
|Condition or disease||Intervention/treatment||Phase|
|Second Trimester Abortion||Device: Laminaria Device: Dilapan-S||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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 Start Date :||December 2013|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Active Comparator: Laminaria
Patients in this arm will receive laminaria cervical dilators one day before D&E procedure.
Active Comparator: Dilapan-S
Patients in this arm will receive Dilapan-S cervical dilators one day before D&E procedure.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033083
|United States, New York|
|Planned Parenthood of New York City|
|New York, New York, United States, 10012|
|Principal Investigator:||Principal Investigator||Planned Parenthood of New York City|