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| ID | Type | Description | Link |
|---|---|---|---|
| MO1RR10710 | Other Grant/Funding Number | General Clinical Research Center (GCRC) |
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| Name | Class |
|---|---|
| Stony Brook University | OTHER |
| Lehigh Valley Hospital | OTHER |
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A multicenter, randomized, controlled, single blinded study to evaluate the effectiveness of Seprafilm® Adhesion Barrier in reducing adhesion formation in cesarean deliveries. Primary outcome will be measurement of the extent and severity of adhesions at the time of subsequent cesarean delivery. Secondary outcomes will include measures of safety, operative times (ex., incision-delivery; total operative time).
Patients presenting to labor and delivery for delivery will be screened for eligibility. If a patient meets the inclusion and exclusion criteria, she will be offered enrollment in the study. After the project and informed consent are reviewed with the patient and all questions are answered, she will be asked to sign the informed consent. At this point, she will be considered a candidate for randomization.
If the patient subsequently undergoes a cesarean delivery, she will be randomized to either:
The investigators will collect additional data about the patient, her antepartum course, intra-operative events, and post-operative course. There are no additional tests or procedures ordered or performed during the hospital stay as part of this protocol. Enrollment in this study is not expected to alter the patient's length of stay.
The antepartum, operative, and post-operative care of the patient will as directed by the patient's physician and participating institutions's standard policies and procedures. This study in no way changes or directs the care the patient would receive, except with regard to the placement of Seprafilm® Adhesion Barrier.
A short-term telephone follow-up will be conducted approximately 6-8 weeks following randomization to assess for immediate post-operative complications.
If a patient becomes pregnant again and undergoes a repeat cesarean delivery at a participating institution, the location and severity of adhesions (if any) would be assessed at the time of repeat cesarean delivery. The investigators will extract additional data from the chart including operative times, blood loss, and complications. An evaluation of adhesions would conclude the patient's participation in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HA-CMC Group | Experimental | Hyaluronic Acid-Carboxymethylcellulose placed as an adhesion barrier |
|
| Routine Closure Group | Placebo Comparator | Routine Closure without placement of an adhesion barrier |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| modified sodium hyaluronic acid and carboxymethylcellulose | Device | Adhesion barrier applied at the time of initial cesarean delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adhesions | The Percentage of participants with one or more adhesions, regardless of the extent or severity | 3 to 5 years |
| Adhesion Score | Adhesion score. Derived by assigning 1 point for filmy adhesion and 2 points for dense adhesions at each of 6 possible sites in the abdomen. Thus the score can range from 0 (i.e., no adhesions at any location) to 12 (dense adhesions at each site). | 3 to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Hemoglobin | Hemoglobin level following randomization delivery - used to determine if there was a difference in blood loss between the two groups | 1 to 5 years |
| Post-operative White Blood Cell Count |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel G Kiefer, M.D. | Lehigh Valley Health Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winthrop University Hospital | Mineola | New York | 11501 | United States | ||
| SUNY Stony Brook University Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | HA-CMC Group | modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery |
| FG001 | Routine Closure Group | Placebo: Routine abdominal closure without placement of adhesion barrier |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HA-CMC Group | modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery |
| BG001 | Routine Closure Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Adhesions | The Percentage of participants with one or more adhesions, regardless of the extent or severity | Posted | Number | percentage of patients with adhesions | 3 to 5 years |
|
From time of enrollment through 8 weeks following randomization
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HA-CMC Group | modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Readmission for Infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Kiefer | Lehigh Valley Health Network | 484-664-7521 | daniel_g.kiefer@lvhn.org |
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| ID | Term |
|---|---|
| D000267 | Tissue Adhesions |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Device | Routine abdominal closure without placement of adhesion barrier |
|
Post-operative White blood cell count following randomization delivery - used to determine if there was difference in immune response or infection between the groups
| 1 to 5 years |
| Post-Operative Complications | Percentage of patients experiencing any of the predefined post-operative complications following randomization | 1 to 5 years |
| Post-operative Maximum Temperature Following Randomization | Maximum temperature of patient, >24 hours following randomization delivery | 1 to 5 years |
| Operative Times at Subsequent Delivery | Amount of time spent at the time of the subsequent delivery | 3 to 5 years |
| Stony Brook |
| New York |
| 11501 |
| United States |
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18103 | United States |
Placebo: Routine abdominal closure without placement of adhesion barrier
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gravid | Mean | Full Range | pregnancies |
|
| Parity | Median | Full Range | pregnancies |
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| Gestational age (weeks) | Mean | Standard Deviation | weeks |
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| Body Mass Index (BMI), kg/m^2 | Mean | Standard Deviation | kg/m^2 |
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| # of previous cesarean births | Median | Full Range | births |
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| Preoperative Hematocrit | Mean | Standard Deviation | percent |
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| Preoperative White Blood cell count | Mean | Standard Deviation | cells/mm^3 |
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| Preoperative Maximum Temperature | Mean | Standard Deviation | degrees Fahrenheit |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Secondary | Post-operative Hemoglobin | Hemoglobin level following randomization delivery - used to determine if there was a difference in blood loss between the two groups | Posted | Mean | Standard Deviation | % of blood that is red blood cells | 1 to 5 years |
|
|
|
| Primary | Adhesion Score | Adhesion score. Derived by assigning 1 point for filmy adhesion and 2 points for dense adhesions at each of 6 possible sites in the abdomen. Thus the score can range from 0 (i.e., no adhesions at any location) to 12 (dense adhesions at each site). | Posted | Median | Full Range | units on a scale | 3 to 5 years |
|
|
|
| Secondary | Post-operative White Blood Cell Count | Post-operative White blood cell count following randomization delivery - used to determine if there was difference in immune response or infection between the groups | Posted | Mean | Standard Deviation | cells/mm^3 | 1 to 5 years |
|
|
|
| Secondary | Post-Operative Complications | Percentage of patients experiencing any of the predefined post-operative complications following randomization | Posted | Number | % of patients experiencing complication | 1 to 5 years |
|
|
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| Secondary | Post-operative Maximum Temperature Following Randomization | Maximum temperature of patient, >24 hours following randomization delivery | Posted | Mean | Standard Deviation | degrees Fahrenheit | 1 to 5 years |
|
|
|
| Secondary | Operative Times at Subsequent Delivery | Amount of time spent at the time of the subsequent delivery | Posted | Median | Full Range | minutes | 3 to 5 years |
|
|
|
| 5 |
| 380 |
| 0 |
| 380 |
| EG001 | Routine Closure Group | Placebo: Routine abdominal closure without placement of adhesion barrier | 2 | 373 | 0 | 373 |
| Readmission for Intra-abdominal complication | Gastrointestinal disorders | Systematic Assessment |
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| Readmission for Central nervous system problem | Nervous system disorders | Systematic Assessment |
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| Readmission for obstetrical complications | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Delayed Postpartum hemorrhage |
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| Ileus or bowel obstruction |
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| Any wound complication |
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| Venous thromboembolism |
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| Readmission (<=6 weeks postpartum) |
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