Clinical trial NCT00697606: Seprafilm® for Prevention of Adhesions at Repeat Cesarean
Official title: Randomized Double-Blind Controlled Study to Determine if Seprafilm® Reduces Adhesions After Primary Cesarean Section
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Adhesion Formation After Primary Cesarean Delivery
Keywords: Seprafilm®
cesarean
adhesions
primary
repeat
Lead sponsor: Abington Memorial Hospital
Sponsor class: OTHER
First posted: 2008-06-16
Enrollment: 450
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To determine if Seprafilm® decreases the incidence of adhesion formation by 50% after primary cesarean.
timeFrame: at repeat cesarean
Secondary outcomes:
measure: To determine to what extent Seprafilm® decreases the incidence of adhesion formation.
timeFrame: at repeat cesarean
measure: To determine the incidence of adhesion formation during repeat cesarean delivery.
timeFrame: at repeat cesarean
measure: 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
timeFrame: at repeat cesarean
measure: 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.
timeFrame: ongoing during trial
Other outcomes:
Locations:
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
Study officials:
affiliation: Abington Memorial Hospital
name: Amy Mackey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abington Memorial Hospital
name: Mark Shahin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abington Memorial Hospital
name: Richard Latta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abington Memorial Hospital
name: David Peleg, MD
role: PRINCIPAL_INVESTIGATOR
References: