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Sponsors and Collaborators: |
Winthrop University Hospital Stony Brook University Lehigh Valley Hospital |
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Information provided by: | Winthrop University Hospital |
ClinicalTrials.gov Identifier: | NCT00565643 |
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), patient perception of pelvic pain, and a cost-effectiveness analysis.
Condition | Intervention | Phase |
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Adhesions Cesarean Section Delivery, Obstetric |
Device: modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier) Device: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Controlled Trial of Seprafilm® Adhesion Barrier to Reduce Adhesion Formation Following Cesarean Delivery |
Estimated Enrollment: | 1800 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | October 2012 |
Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Device: modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier)
Adhesion barrier applied at the time of initial cesarean delivery
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B: Placebo Comparator |
Device: Placebo
Routine abdominal closure without placement of adhesion barrier
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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:
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 Seprafilm® Adhesion Barrier.
A short-term telephone follow-up will be conducted approximately 6-8 weeks following randomization to assess for immediate post-operative complications and to assess blinding effectiveness. Patients will then be contacted by mail survey periodically (approximately every six months) to assess their pregnancy/fertility status, pregnancy plans, and complete a brief survey on pelvic pain.
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.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Daniel G Kiefer, M.D. | 631-444-8411 | dkiefer@notes.cc.sunysb.edu |
United States, New York | |
Winthrop University Hospital | Recruiting |
Mineola, New York, United States, 11501 | |
Contact: Graham Ashmead, M.D. 516-663-8661 GAshmead@winthrop.org | |
SUNY Stony Brook University Hospital | Recruiting |
Stony Brook, New York, United States, 11501 | |
Contact: Daniel Kiefer, M.D. 631-444-8411 dkiefer@notes.cc.sunysb.edu | |
United States, Pennsylvania | |
Lehigh Valley Hospital | Not yet recruiting |
Allentown, Pennsylvania, United States, 18105 | |
Contact: Orion Rust, MD 610-402-8501 orion.rust@lvh.com |
Principal Investigator: | Daniel G Kiefer, M.D. | SUNY Stony Brook University |
Responsible Party: | Winthrop-Unviersity Hospital ( Daniel Kiefer, MD ) |
Study ID Numbers: | IRB No. 07023, 07023 |
Study First Received: | November 29, 2007 |
Last Updated: | June 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00565643 |
Health Authority: | United States: Institutional Review Board |
Adhesion Seprafilm Cesarean section |
Hyaluronic Acid Adhesions |
Pathologic Processes Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions |