A Phase 4 interventional study of modified sodium hyaluronic acid and carboxymethylcellulose and Placebo in Adhesions, Cesarean Section and Delivery, Obstetric, sponsored by Winthrop University Hospital. Completed at 3 sites in United States. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-14.
Sponsored by Winthrop University Hospital · Phase 4, Interventional, and Treatment
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.
Exclusion Criteria:
Hyaluronic Acid-Carboxymethylcellulose placed as an adhesion barrier
Device: modified sodium hyaluronic acid and carboxymethylcellulose
Routine Closure without placement of an adhesion barrier
Device: Placebo
Adhesion barrier applied at the time of initial cesarean delivery
Also known as: Seprafilm Adhesion Barrier
Routine abdominal closure without placement of adhesion barrier
Incidence of Adhesions
The Percentage of participants with one or more adhesions, regardless of the extent or severity
Time frame: 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).
Time frame: 3 to 5 years
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
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
Post-Operative Complications
Percentage of patients experiencing any of the predefined post-operative complications following randomization
Time frame: 1 to 5 years
Post-operative Maximum Temperature Following Randomization
Maximum temperature of patient, \>24 hours following randomization delivery
Time frame: 1 to 5 years
Operative Times at Subsequent Delivery
Amount of time spent at the time of the subsequent delivery
Time frame: 3 to 5 years
| Milestone | HA-CMC Group | Routine Closure Group |
|---|---|---|
| Started | 380 | 373 |
| Safety data | 380 | 373 |
| Primary outcome (subsequent cesarean) | 80 | 92 |
| Completed | 380 | 373 |
| Not completed | 0 | 0 |
The Percentage of participants with one or more adhesions, regardless of the extent or severity
| percentage of patients with adhesions | HA-CMC Group | Routine Closure Group |
|---|---|---|
| Incidence of Adhesions | 75.6 | 75.9 |
Hemoglobin level following randomization delivery - used to determine if there was a difference in blood loss between the two groups
| % of blood that is red blood cells | HA-CMC Group | Routine Closure Group |
|---|---|---|
| Post-operative Hemoglobin | 29.9 ± 4.1 | 30.2 ± 3.6 |
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).
| units on a scale | HA-CMC Group | Routine Closure Group |
|---|---|---|
| Adhesion Score | 2 (0 to 10) | 2 (0 to 8) |
Post-operative White blood cell count following randomization delivery - used to determine if there was difference in immune response or infection between the groups
| cells/mm^3 | HA-CMC Group | Routine Closure Group |
|---|---|---|
| Post-operative White Blood Cell Count | 11.3 ± 6.4 | 11.0 ± 3.3 |
Percentage of patients experiencing any of the predefined post-operative complications following randomization
| % of patients experiencing complication | HA-CMC Group | Routine Closure Group |
|---|---|---|
| Any complication | 6.3 | 4.0 |
| Fever | 4.5 | 3.0 |
| Ileus or bowel obstruction | 0 | 0 |
| Any wound complication | 2.1 | 0.8 |
| Venous thromboembolism | 0 | 0.3 |
| Readmission (<=6 weeks postpartum) | 1.3 | 0.5 |
Maximum temperature of patient, \>24 hours following randomization delivery
| degrees Fahrenheit | HA-CMC Group | Routine Closure Group |
|---|---|---|
| Post-operative Maximum Temperature Following Randomization | 98.2 ± 1.0 | 98.2 ± 0.9 |
Amount of time spent at the time of the subsequent delivery
| minutes | HA-CMC Group | Routine Closure Group |
|---|---|---|
| Skin-to-delivery | 13 (3 to 70) | 13 (4 to 55) |
| Total operative time | 51 (23 to 175) | 54 (26 to 157) |
Collected over From time of enrollment through 8 weeks following randomization. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HA-CMC Group | — | 5/380 (1.3%) | 0/380 (0%) |
| Routine Closure Group | — | 2/373 (0.5%) | 0/373 (0%) |
| Event | HA-CMC Group | Routine Closure Group |
|---|---|---|
| Readmission for InfectionInfections and infestations | 2/380 | 1/373 |
| Readmission for Intra-abdominal complicationGastrointestinal disorders | 2/380 | 0/373 |
| Readmission for Central nervous system problemNervous system disorders | 0/380 | 1/373 |
| Readmission for obstetrical complicationsPregnancy, puerperium and perinatal conditions | 1/380 | 0/373 |
| Age, Continuous(years) | HA-CMC Group | Routine Closure Group | Total |
|---|---|---|---|
| Mean | 30.4 ± 5.1 | 30.9 ± 5.3 | NA ± NA |
| Sex: Female, Male(Participants) | HA-CMC Group | Routine Closure Group | Total |
|---|---|---|---|
| Female | 380 | 373 | 753 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | HA-CMC Group | Routine Closure Group | Total |
|---|---|---|---|
| United States | 380 | 373 | 753 |
| Gravid(pregnancies) | HA-CMC Group | Routine Closure Group | Total |
|---|---|---|---|
| Mean | 2 (1 to 20) | 2 (1 to 11) | NA (NA to NA) |
| Parity(pregnancies) | HA-CMC Group | Routine Closure Group | Total |
|---|---|---|---|
| Median | 1 (0 to 4) | 1 (0 to 4) | NA (NA to NA) |
| Gestational age (weeks)(weeks) | HA-CMC Group | Routine Closure Group | Total |
|---|---|---|---|
| Mean | 38.7 ± 1.9 | 38.1 ± 3.9 | NA ± NA |
| Body Mass Index (BMI), kg/m^2(kg/m^2) | HA-CMC Group | Routine Closure Group | Total |
|---|---|---|---|
| Mean | 33.3 ± 6.6 | 33.2 ± 7.8 | NA ± NA |
| # of previous cesarean births(births) | HA-CMC Group | Routine Closure Group | Total |
|---|---|---|---|
| Median | 1 (0 to 3) | 1 (0 to 3) | NA (NA to NA) |
3 further baseline measures are reported on the registry.
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Winthrop University Hospital