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Not Recruiting
Trial ID: NCT01801475
Prevention of Neonatal Abstinence Syndrome
Professor of Anesthesiology, Perioperative and Pain Medicine
Inclusion Criteria:
For Non-pregnant Females (Group #1)
1. Age 18-45 yrs inclusive
2. Generally healthy
3. Undergoing any scheduled surgical procedure deemed suitable by the Investigator MD
4. Planned to receive the drug Ondansetron for the surgery
5. Able and willing to sign the informed consent
For Pregnant Females (Group #2)
1. Age 18-45 yrs inclusive
2. Term pregnancy (37 weeks through 41 wks + 6 days)
3. Generally healthy (not morbidly obese)
4. Undergoing a planned C-section or by an unplanned, non-urgent C-section
5. Planned to receive the drug Ondansetron for the surgery
6. Single birth
7. Able and willing to sign the informed consent for herself & the baby
For the Neonatal Participant (Group #3)
1. Male or female
2. Viable birth
3. Gestational age of 37 weeks through 41 weeks + 6 days
4. Mother gave written consent for baby to participate
Exclusion Criteria:
1. Medical condition that would effect the metabolism of ondansetron
2. Known allergy to ondansetron
3. Use of medications in the last 48 hours, by the pregnant or non-pregnant subjects,
that might induce or inhibit the metabolism of ondansetron (such as CYP3A4 inhibitors
or inducers)
drug: Ondansetron
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305