Adhesions, Cesarean Section, Delivery, Obstetric
Conditions
Keywords
Adhesion, Seprafilm, Cesarean section
Brief summary
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).
Detailed description
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: 1. Group A - Placement of Seprafilm® prior to abdominal closure 2. Group B - Routine closure without placement of Seprafilm® The chances of being assigned to either group will be equal (i.e., 1:1 randomization). The patient will be blinded with regard to Seprafilm placement. 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.
Interventions
DEVICEmodified sodium hyaluronic acid and carboxymethylcellulose
Adhesion barrier applied at the time of initial cesarean delivery
DEVICEPlacebo
Routine abdominal closure without placement of adhesion barrier
Sponsors
Stony Brook University
Lehigh Valley Hospital
Winthrop University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women who are planning or have the potential to undergo cesarean delivery * Age over 18 * Able to consent to study
Exclusion criteria
* Planned tubal ligation * Known allergy to hyaluronic acid * Medical or other serious condition which will interfere with compliance and/or ability to complete study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adhesions | 3 to 5 years | The Percentage of participants with one or more adhesions, regardless of the extent or severity |
| Adhesion Score | 3 to 5 years | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-Operative Complications | 1 to 5 years | Percentage of patients experiencing any of the predefined post-operative complications following randomization |
| Post-operative Hemoglobin | 1 to 5 years | Hemoglobin level following randomization delivery - used to determine if there was a difference in blood loss between the two groups |
| Operative Times at Subsequent Delivery | 3 to 5 years | Amount of time spent at the time of the subsequent delivery |
| Post-operative Maximum Temperature Following Randomization | 1 to 5 years | Maximum temperature of patient, \>24 hours following randomization delivery |
| Post-operative White Blood Cell Count | 1 to 5 years | Post-operative White blood cell count following randomization delivery - used to determine if there was difference in immune response or infection between the groups |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HA-CMC Group modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery | 380 |
| Routine Closure Group Placebo: Routine abdominal closure without placement of adhesion barrier | 373 |
| Total | 753 |
Baseline characteristics
| Characteristic | HA-CMC Group | Routine Closure Group | Total |
|---|---|---|---|
| Age, Continuous | 30.4 years STANDARD_DEVIATION 5.1 | 30.9 years STANDARD_DEVIATION 5.3 | NA years |
| Body Mass Index (BMI), kg/m^2 | 33.3 kg/m^2 STANDARD_DEVIATION 6.6 | 33.2 kg/m^2 STANDARD_DEVIATION 7.8 | NA kg/m^2 |
| Gestational age (weeks) | 38.7 weeks STANDARD_DEVIATION 1.9 | 38.1 weeks STANDARD_DEVIATION 3.9 | NA weeks |
| Gravid | 2 pregnancies | 2 pregnancies | NA pregnancies |
| # of previous cesarean births | 1 births | 1 births | NA births |
| Parity | 1 pregnancies | 1 pregnancies | NA pregnancies |
| Preoperative Hematocrit | 34.8 percent STANDARD_DEVIATION 4.3 | 34.4 percent STANDARD_DEVIATION 5 | NA percent |
| Preoperative Maximum Temperature | 97.8 degrees Fahrenheit STANDARD_DEVIATION 1 | 97.9 degrees Fahrenheit STANDARD_DEVIATION 0.9 | NA degrees Fahrenheit |
| Preoperative White Blood cell count | 10.3 cells/mm^3 STANDARD_DEVIATION 3.4 | 10.7 cells/mm^3 STANDARD_DEVIATION 4.6 | NA cells/mm^3 |
| Region of Enrollment United States | 380 participants | 373 participants | 753 participants |
| Sex: Female, Male Female | 380 Participants | 373 Participants | 753 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 380 | 0 / 373 |
| serious Total, serious adverse events | 5 / 380 | 2 / 373 |
Outcome results
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).
Time frame: 3 to 5 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| HA-CMC Group | Adhesion Score | 2 units on a scale |
| Routine Closure Group | Adhesion Score | 2 units on a scale |
Primary
Incidence of Adhesions
The Percentage of participants with one or more adhesions, regardless of the extent or severity
Time frame: 3 to 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HA-CMC Group | Incidence of Adhesions | 75.6 percentage of patients with adhesions |
| Routine Closure Group | Incidence of Adhesions | 75.9 percentage of patients with adhesions |
Secondary
Operative Times at Subsequent Delivery
Amount of time spent at the time of the subsequent delivery
Time frame: 3 to 5 years
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HA-CMC Group | Operative Times at Subsequent Delivery | Skin-to-delivery | 13 minutes |
| HA-CMC Group | Operative Times at Subsequent Delivery | Total operative time | 51 minutes |
| Routine Closure Group | Operative Times at Subsequent Delivery | Skin-to-delivery | 13 minutes |
| Routine Closure Group | Operative Times at Subsequent Delivery | Total operative time | 54 minutes |
Secondary
Post-Operative Complications
Percentage of patients experiencing any of the predefined post-operative complications following randomization
Time frame: 1 to 5 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HA-CMC Group | Post-Operative Complications | Any wound complication | 2.1 % of patients experiencing complication |
| HA-CMC Group | Post-Operative Complications | Fever | 4.5 % of patients experiencing complication |
| HA-CMC Group | Post-Operative Complications | Venous thromboembolism | 0 % of patients experiencing complication |
| HA-CMC Group | Post-Operative Complications | Ileus or bowel obstruction | 0 % of patients experiencing complication |
| HA-CMC Group | Post-Operative Complications | Readmission (<=6 weeks postpartum) | 1.3 % of patients experiencing complication |
| HA-CMC Group | Post-Operative Complications | Any complication | 6.3 % of patients experiencing complication |
| Routine Closure Group | Post-Operative Complications | Readmission (<=6 weeks postpartum) | 0.5 % of patients experiencing complication |
| Routine Closure Group | Post-Operative Complications | Any complication | 4.0 % of patients experiencing complication |
| Routine Closure Group | Post-Operative Complications | Ileus or bowel obstruction | 0 % of patients experiencing complication |
| Routine Closure Group | Post-Operative Complications | Any wound complication | 0.8 % of patients experiencing complication |
| Routine Closure Group | Post-Operative Complications | Venous thromboembolism | 0.3 % of patients experiencing complication |
| Routine Closure Group | Post-Operative Complications | Fever | 3.0 % of patients experiencing complication |
Secondary
Post-operative Hemoglobin
Hemoglobin level following randomization delivery - used to determine if there was a difference in blood loss between the two groups
Time frame: 1 to 5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HA-CMC Group | Post-operative Hemoglobin | 29.9 % of blood that is red blood cells | Standard Deviation 4.1 |
| Routine Closure Group | Post-operative Hemoglobin | 30.2 % of blood that is red blood cells | Standard Deviation 3.6 |
Secondary
Post-operative Maximum Temperature Following Randomization
Maximum temperature of patient, \>24 hours following randomization delivery
Time frame: 1 to 5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HA-CMC Group | Post-operative Maximum Temperature Following Randomization | 98.2 degrees Fahrenheit | Standard Deviation 1 |
| Routine Closure Group | Post-operative Maximum Temperature Following Randomization | 98.2 degrees Fahrenheit | Standard Deviation 0.9 |
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
Time frame: 1 to 5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HA-CMC Group | Post-operative White Blood Cell Count | 11.3 cells/mm^3 | Standard Deviation 6.4 |
| Routine Closure Group | Post-operative White Blood Cell Count | 11.0 cells/mm^3 | Standard Deviation 3.3 |