Seprafilm® for Prevention of Adhesions at Repeat Cesarean

Study Overview
=================
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.

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.

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

Conditions
-----------------
Adhesion Formation After Primary Cesarean Delivery

Intervention / Treatment
-----------------
* Device: Seprafilm®
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Seprafilm® | Device: Seprafilm®<br>* Seprafilm® placed at time of primary cesarean<br>|
| Sham Comparator: B<br>Control | Other: Control<br>* no Seprafilm® used at primary cesarean<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if Seprafilm® decreases the incidence of adhesion formation by 50% after primary cesarean. |  | at repeat cesarean | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Seprafilm®, cesarean, adhesions, primary, repeat