Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 12:35 AM
NCT ID:
NCT01819467
Eligibility Criteria:
Inclusion Criteria:
* Females 12 years and older undergoing a scheduled primary cesarean section at or after 24 weeks estimated gestational period
Exclusion Criteria:
* 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:
1. 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
2. Patients who have pelvic abscess or diverticulitis
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
12 Years
Study:
NCT01819467
Study Brief:
Protocol Section:
NCT01819467