Dilapan Versus Laminaria (DvL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00775983|
Recruitment Status : Completed
First Posted : October 20, 2008
Results First Posted : July 17, 2013
Last Update Posted : November 14, 2013
This is a randomized, blinded clinical trial comparing overnight laminaria versus same-day Dilapan for cervical preparation for surgical abortions occurring between fourteen and eighteen weeks gestation. Comparisons will be made between procedure time, need for additional dilation, occurrence of complications, and patient and provider satisfaction.
Cervical preparation for surgical abortion, between fourteen and eighteen weeks gestation, with same-day Dilapan is non-inferior to cervical preparation with overnight laminaria within a five-minute difference.
Determine differences in procedure times
Examine complications, and need for additional dilation between early second-trimester surgical abortions performed after cervical preparation with same-day Dilapan versus those performed after cervical preparation with overnight laminaria
|Condition or disease||Intervention/treatment|
|Cervical Preparation||Device: laminaria Device: Dilapan-S|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Same-day Dilapan Versus Overnight Laminaria for Cervical Preparation for Early Second-trimester Surgical Abortion|
|Study Start Date :||October 2008|
|Primary Completion Date :||December 2009|
|Study Completion Date :||December 2009|
Active Comparator: laminaria
laminaria placed for cervical dilation; usual standard of care in study clinic
place device in cervix for dilation
Place in cervix for dilation.
- Procedure Time [ Time Frame: Day of procedure ]Procedure time to complete early second-trimester dilation and evacuation (D&E)
- Participants Who Experienced Complications or Need for Additional Dilation [ Time Frame: Day of procedure ]Any complications, or mechanical dilation required, for early second-trimester surgical abortions performed after cervical preparation with same-day Dilapan versus those performed after cervical preparation with overnight laminaria
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): NCT00775983
|United States, California|
|San Francisco General Hospital|
|San Francisco, California, United States, 94110|