Seprafilm® for Prevention of Adhesions at Repeat Cesarean (SPARC)
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ClinicalTrials.gov Identifier: NCT00697606 |
Recruitment Status
:
Terminated
(lack of funding)
First Posted
: June 16, 2008
Last Update Posted
: December 30, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Adhesion Formation After Primary Cesarean Delivery | Device: Seprafilm® Other: Control | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
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 : | July 2008 |
Actual Primary Completion Date : | June 2011 |
Actual Study Completion Date : | June 2011 |
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
|
- To determine if Seprafilm® decreases the incidence of adhesion formation by 50% after primary cesarean. [ Time Frame: at repeat cesarean ]
- To determine to what extent Seprafilm® decreases the incidence of adhesion formation. [ Time Frame: at repeat cesarean ]
- To determine the incidence of adhesion formation during repeat cesarean delivery. [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: ongoing during trial ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00697606
United States, Pennsylvania | |
Abington Memorial Hospital | |
Abington, Pennsylvania, United States, 19001 |
Principal Investigator: | Amy Mackey, MD | Abington Memorial Hospital | |
Principal Investigator: | Mark Shahin, MD | Abington Memorial Hospital | |
Principal Investigator: | Richard Latta, MD | Abington Memorial Hospital | |
Principal Investigator: | David Peleg, MD | Abington Memorial Hospital |
Responsible Party: | David Peleg, MD, Principle Investigator, Abington Memorial Hospital |
ClinicalTrials.gov Identifier: | NCT00697606 History of Changes |
Other Study ID Numbers: |
Study #08-032 |
First Posted: | June 16, 2008 Key Record Dates |
Last Update Posted: | December 30, 2015 |
Last Verified: | December 2015 |
Keywords provided by David Peleg, MD, Abington Memorial Hospital:
Seprafilm® cesarean adhesions primary repeat |
Additional relevant MeSH terms:
Tissue Adhesions Cicatrix Fibrosis Pathologic Processes Hyaluronic Acid |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Viscosupplements Protective Agents |