Status:
TERMINATED
Seprafilm® for Prevention of Adhesions at Repeat Cesarean
Lead Sponsor:
Abington Memorial Hospital
Conditions:
Adhesion Formation After Primary Cesarean Delivery
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
Brief Summary
Adhesion formation is a result of abdominal and pelvic surgery and is a cause of such diseases as chronic pain syndrome, bowel obstruction and infertility. Both patients and surgeons suffer when adhes...
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). Sep...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00697606
Start Date
July 1 2008
End Date
June 1 2011
Last Update
December 30 2015
Active Locations (1)
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1
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001