SPARC: Seprafilm® for Prevention of Adhesions at Repeat Cesarean

Sponsor

Abington Memorial Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT00697606

Collaborator

(none)

450

Enrollment

Location

Arms

Duration (Months)

12.9

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Adhesion Formation After Primary Cesarean Delivery	Device: Seprafilm® Other: Control	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

450 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Seprafilm®	Device: Seprafilm® Seprafilm® placed at time of primary cesarean
Sham Comparator: B Control	Other: Control no Seprafilm® used at primary cesarean

Arm

Intervention/Treatment

Experimental: A

Seprafilm®

Device: Seprafilm®

Seprafilm® placed at time of primary cesarean

Sham Comparator: B

Control

Other: Control

no Seprafilm® used at primary cesarean

Outcome Measures

Primary Outcome Measures

To determine if Seprafilm® decreases the incidence of adhesion formation by 50% after primary cesarean. [at repeat cesarean]

Secondary Outcome Measures

To determine to what extent Seprafilm® decreases the incidence of adhesion formation. [at repeat cesarean]
To determine the incidence of adhesion formation during repeat cesarean delivery. [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 [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. [ongoing during trial]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.