Status:
TERMINATED
A Trial to Reduce Adhesions Following a Primary Cesarean Section
Lead Sponsor:
South East Area Health Education Center, Wilmington, NC
Collaborating Sponsors:
New Hanover Regional Medical Center
Conditions:
Tissue Adhesions
Eligibility:
FEMALE
12+ years
Phase:
NA
Brief Summary
The primary objective of this study is to determine whether the use of Seprafilm reduces the incidence rate of adhesion formation following a primary C-section. A secondary objective of the study wil...
Detailed Description
A cesarean section or delivery (C-section/CD) is the surgical removal of an infant and placenta through the mother's abdominal and uterine wall. This procedure is performed by an obstetrician and is o...
Eligibility Criteria
Inclusion
- Females 12 years and older undergoing a scheduled primary cesarean section at or after 24 weeks estimated gestational period
Exclusion
- Patients transferred from outlying hospitals who expect to undergo repeat C-section at that hospital.
- Patients who have had previous laparotomy
- Patients having a previous laparoscopy demonstrating adhesions of bladder peritoneum or uterine serosa or myometrium to the parietal peritoneum or omentum or bowel to the uterus or parietal peritoneum; or involving pelvic adhesiolysis, enterolysis or other surgery on bowel located in the pelvis, uterine myomectomy , adnexectomy or other adnexal surgery including ovarian cystectomy, tuboplasty, tubal reanastomosis, and removal of endometriosis
- Patients with an adhesion score \> 0 at the time of primary cesarean section
- Patents with chorioamnionitis, appendicitis or infection of other pelvic viscera at the time of primary cesarean section.
- Patients who have taken systemic corticosteroids within 2 weeks of the primary cesarean section. Provided however, patients who have been treated with systemic betamethasone or dexamethasone to promote fetal lung maturity are not excluded
- Patients undergoing tubal sterilization at the time of the primary cesarean section
- Patients with known allergy to hyaluronic acid
- The following criteria are seen as complications or adverse events experienced by the patients in the interval after the puerperium and will therefore exclude patients:
- Patient who have had a pelvic inflammatory disease documented by either cervical motion, uterine or adnexal tenderness; and either oral temperature \> 101 degrees or mucopurulent cervical discharge or cervical culture positive for C. trachomatis or N. Gonorrhoeae
- Patients who have pelvic abscess or diverticulitis
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01819467
Start Date
June 1 2014
End Date
September 1 2016
Last Update
August 16 2023
Active Locations (1)
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1
New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28401