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:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-24 @ 11:55 PM
NCT ID:
NCT04993651
Eligibility Criteria:
Inclusion Criteria:
* Pregnant women between the ages of 18-45
* Body mass index of 40 kg/m2 or greater at the time patient is scheduled for cesarean delivery
* Singleton gestation
* Scheduled for primary or repeat cesarean delivery at Sentara Norfolk General Hospital
* Gestational age between 37+0 and 41+0 weeks at the time of delivery
* Non-stress test on admission with moderate variability, without repetitive late or variable decelerations
* Negative SARS-CoV-2 PCR test within 72 hours of procedure
Exclusion Criteria:
* Fetal growth restriction
* Active pulmonary diseases to include pneumonia, sarcoidosis, pulmonary hypertension, moderate or severe persistent asthma
* Suspected placenta accreta based on prenatal sonographic evaluation
* Active maternal infection to include pyelonephritis, appendicitis, upper respiratory tract infection, urinary tract infection or suspected intra-amniotic infection
* SARS-CoV-2 positive test within past 10 days or ongoing symptoms of SARS-CoV-2 to include cough, fever or shortness of breath with positive test greater than 10 days prior, or history of hospitalization for SARS-CoV-2 infection
* Fetus with aneuploidy or major anomaly
* Enrolled in another trial that may affect outcome
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04993651
Study Brief:
Protocol Section:
NCT04993651