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Seprafilm® for Prevention of Adhesions at Repeat Cesarean

NCT ID: NCT00697606

Last Updated: 2015-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Adhesion Formation After Primary Cesarean Delivery

Keywords

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Seprafilm® cesarean adhesions primary repeat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Seprafilm®

Group Type EXPERIMENTAL

Seprafilm®

Intervention Type DEVICE

Seprafilm® placed at time of primary cesarean

B

Control

Group Type SHAM_COMPARATOR

Control

Intervention Type OTHER

no Seprafilm® used at primary cesarean

Interventions

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Seprafilm®

Seprafilm® placed at time of primary cesarean

Intervention Type DEVICE

Control

no Seprafilm® used at primary cesarean

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Abington Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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David Peleg, MD

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amy Mackey, MD

Role: PRINCIPAL_INVESTIGATOR

Abington Memorial Hospital

Mark Shahin, MD

Role: PRINCIPAL_INVESTIGATOR

Abington Memorial Hospital

Richard Latta, MD

Role: PRINCIPAL_INVESTIGATOR

Abington Memorial Hospital

David Peleg, MD

Role: PRINCIPAL_INVESTIGATOR

Abington Memorial Hospital

Locations

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Abington Memorial Hospital

Abington, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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Study #08-032

Identifier Type: -

Identifier Source: org_study_id