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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT04612920
Eligibility Criteria:
Inclusion Criteria:
* Undergoing repeat cesarean delivery
* ≥37 week gestation
* attended at least 7 prenatal visits
* age ≥18.
Exclusion Criteria:
* Non-English speaking, attended \< 7 prenatal visits, fetal anomalies or death, inability to ambulate, BMI ≥45kg/m2 at delivery due to higher risk of regional analgesia complications, placental implantation abnormalities, maternal diabetes due to the risk of wound complications, chorioamnionitis, allergy to study medications, underlying renal or hepatic impairment, opioid use in the last 3 months, chronic controlled substance use, chronic pain disorders, history of narcotic addiction, intraoperative hemorrhage not controlled with medication alone, additional concurrent surgeries other than sterilization procedures and presence of endometriosis noted at time of surgery. Patients will be enrolled and randomized to their respective groups after completion of the surgery, as there may be surgical complications that preclude their final enrollment as described in the exclusion criteria.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04612920
Study Brief:
Protocol Section:
NCT04612920