Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT00565643 |
Other study ID # |
IRB No. 07023 |
Secondary ID |
MO1RR10710 |
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
November 2007 |
Est. completion date |
October 2014 |
Study information
Verified date |
April 2024 |
Source |
Winthrop University Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
A multicenter, randomized, controlled, single blinded study to evaluate the effectiveness of
Seprafilm® Adhesion Barrier in reducing adhesion formation in cesarean deliveries. Primary
outcome will be measurement of the extent and severity of adhesions at the time of subsequent
cesarean delivery. Secondary outcomes will include measures of safety, operative times (ex.,
incision-delivery; total operative time).
Description:
Patients presenting to labor and delivery for delivery will be screened for eligibility. If a
patient meets the inclusion and exclusion criteria, she will be offered enrollment in the
study. After the project and informed consent are reviewed with the patient and all questions
are answered, she will be asked to sign the informed consent. At this point, she will be
considered a candidate for randomization.
If the patient subsequently undergoes a cesarean delivery, she will be randomized to either:
1. Group A - Placement of SeprafilmĀ® prior to abdominal closure
2. Group B - Routine closure without placement of SeprafilmĀ® The chances of being assigned
to either group will be equal (i.e., 1:1 randomization). The patient will be blinded
with regard to Seprafilm placement.
The investigators will collect additional data about the patient, her antepartum course,
intra-operative events, and post-operative course. There are no additional tests or
procedures ordered or performed during the hospital stay as part of this protocol. Enrollment
in this study is not expected to alter the patient's length of stay.
The antepartum, operative, and post-operative care of the patient will as directed by the
patient's physician and participating institutions's standard policies and procedures. This
study in no way changes or directs the care the patient would receive, except with regard to
the placement of SeprafilmĀ® Adhesion Barrier.
A short-term telephone follow-up will be conducted approximately 6-8 weeks following
randomization to assess for immediate post-operative complications.
If a patient becomes pregnant again and undergoes a repeat cesarean delivery at a
participating institution, the location and severity of adhesions (if any) would be assessed
at the time of repeat cesarean delivery. The investigators will extract additional data from
the chart including operative times, blood loss, and complications. An evaluation of
adhesions would conclude the patient's participation in the study.