Seprafilm® for Prevention of Adhesions at Repeat Cesarean

Adhesion Formation After Primary Cesarean Delivery Clinical Trial

— SPARC  

Official title:

Randomized Double-Blind Controlled Study to Determine if Seprafilm® Reduces Adhesions After Primary Cesarean Section

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00697606
• Other study ID #: Study #08-032
• Status: Terminated
• Phase: Phase 3
• First received: June 12, 2008
• Last updated: December 29, 2015
• Start date: July 2008
• Est. completion date: June 2011

Study information

• Verified date: December 2015
• Source: Abington Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 450
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Pregnant women after 24 weeks' gestation.

2. First cesarean delivery.

3. Age > 18 years.

4. Cesarean to be performed by a participating surgeon.

5. Non-closure of the visceral or parietal peritoneum.

Exclusion Criteria:

1. Any prior abdominal surgery including prior cesarean, laparoscopy, appendectomy, cholecystectomy or any uterine adnexal or bowel surgery.

2. Clinical diagnosis of chorioamnionitis.

3. Women having tubal ligation at the time of primary cesarean.

4. Inability to obtain informed consent.

Related Conditions & MeSH terms

• Adhesion Formation After Primary Cesarean Delivery
• Tissue Adhesions

Intervention

Device:
• Seprafilm®
Seprafilm® placed at time of primary cesarean

Other:
• Control
no Seprafilm® used at primary cesarean

Locations

Country	Name	City	State
United States	Abington Memorial Hospital	Abington	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abington Memorial Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if Seprafilm® decreases the incidence of adhesion formation by 50% after primary cesarean.		at repeat cesarean
Secondary	To determine to what extent Seprafilm® decreases the incidence of adhesion formation.		at repeat cesarean
Secondary	To determine the incidence of adhesion formation during repeat cesarean delivery.		at repeat cesarean
Secondary	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		at repeat cesarean
Secondary	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.		ongoing during trial