- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00697606
Seprafilm® for Prevention of Adhesions at Repeat Cesarean (SPARC)
Randomized Double-Blind Controlled Study to Determine if Seprafilm® Reduces Adhesions After Primary Cesarean Section
Study Overview
Status
Intervention / Treatment
Detailed Description
This is a prospective randomized double-blinded study. Patients will be randomized prior to primary cesarean section to either the study arm (Seprafilm® placement) or control arm (nothing placed). Seprafilm® will be placed over the repaired uterine incision and over the anterior aspect of the uterus prior to closure of the fascia (2 to 3 sheets per patient). Randomization will be by opaque envelops containing group assignment.
Participants and surgeons will be blinded to group designation at the time of repeat cesarean. The surgeon will be asked to grade the adhesions at the time of repeat cesarean.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Abington, Pennsylvania, United States, 19001
- Abington Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pregnant women after 24 weeks' gestation.
- First cesarean delivery.
- Age > 18 years.
- Cesarean to be performed by a participating surgeon.
- Non-closure of the visceral or parietal peritoneum.
Exclusion Criteria:
- Any prior abdominal surgery including prior cesarean, laparoscopy, appendectomy, cholecystectomy or any uterine adnexal or bowel surgery.
- Clinical diagnosis of chorioamnionitis.
- Women having tubal ligation at the time of primary cesarean.
- Inability to obtain informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
Seprafilm®
|
Seprafilm® placed at time of primary cesarean
|
Sham Comparator: B
Control
|
no Seprafilm® used at primary cesarean
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine if Seprafilm® decreases the incidence of adhesion formation by 50% after primary cesarean.
Time Frame: at repeat cesarean
|
at repeat cesarean
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine to what extent Seprafilm® decreases the incidence of adhesion formation.
Time Frame: at repeat cesarean
|
at repeat cesarean
|
To determine the incidence of adhesion formation during repeat cesarean delivery.
Time Frame: at repeat cesarean
|
at repeat cesarean
|
To evaluate complication rates in those with Seprafilm® versus those without during repeat surgery by examining length of operating times, blood loss, bladder injuries, and Apgar scores
Time Frame: at repeat cesarean
|
at repeat cesarean
|
To determine the incidence of fertility issues in women having Seprafilm® placed during primary cesarean delivery versus those not having Seprafilm® placed. Participating women will be contacted by telephone every 4 months.
Time Frame: ongoing during trial
|
ongoing during trial
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amy Mackey, MD, Abington Memorial Hospital
- Principal Investigator: Mark Shahin, MD, Abington Memorial Hospital
- Principal Investigator: Richard Latta, MD, Abington Memorial Hospital
- Principal Investigator: David Peleg, MD, Abington Memorial Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Study #08-032
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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