Seprafilm® for Prevention of Adhesions at Repeat Cesarean
Stopped early · Phase 3
Conditions studied: Adhesion Formation After Primary Cesarean Delivery
In brief
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 adhesions are encountered, since the surgery becomes more intense, lengthy, and complicated. Seprafilm® has been shown to limit the formation of adhesions in gynecologic and abdominal surgery. Limited data is available on the effectiveness of Seprafilm® in the prevention of abdominal wall and pelvic adhesions at the time of cesarean section. Adhesions at the time of repeat cesarean make the surgery frustrating and complex, with difficult lysis of adhesions being the cause of morbidities such as bladder damage, increased blood loss, and longer operating times. The objective of this definitive project is to define the extent of reduction of adhesion formation of Seprafilm® when used at the time of primary cesarean section. Women undergoing primary cesarean section will be randomized for Seprafilm® application, and the incidence and grade of adhesions at repeat cesarean will be determined.
Key facts
- Study ID
- NCT00697606
- Run by
- Abington Memorial Hospital
- People needed
- 450
- Starts
- 2008-07-01
- Expected to finish
- 2011-06-01
- Last updated by the study team
- 2015-12-30
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Abington Memorial Hospital — Abington, Pennsylvania, United States
Full record on ClinicalTrials.gov
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