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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT01357369
Eligibility Criteria:
Inclusion Criteria:
Adult participant:
* Age 18-45 years old
* Term pregnancy (37-42 weeks)
* Delivers by planned cesarean section, or unplanned, non-urgent cesarean section.
* Generally healthy
* Able and willing to sign informed consent
Neonatal participant:
* Male of female
* 37-42 weeks gestation
Exclusion Criteria:
* Adult:Medical condition that would effect metabolism of the study drugs
* Known allergy to either study medication
* Use of medications in the last 48 hours that might induce or inhibit metabolism of ondansetron (e.g. barbiturates, fluconazole, erythromycin, etc.)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01357369
Study Brief:
Protocol Section:
NCT01357369