Status:
COMPLETED
How Pregnant Women and Their Babies Metabolize Ondansetron Compared to a Group of Non-pregnant Women
Lead Sponsor:
Stanford University
Conditions:
Postoperative Nausea
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
PHASE2
Brief Summary
This is called "Aim 1" of the investigators' NIH grant. Ondansetron (Zofran) is a safe and effective drug used in pregnant women to prevent nausea but the investigators do not know what effect pregnan...
Detailed Description
This phase of the study is Aim 1 and it will lead to Aim 2, which specifically will address the Prevention of Neonatal Abstinence Syndrome (NAS). NAS is a constellation of narcotic drug withdrawal sy...
Eligibility Criteria
Inclusion
- For Non-pregnant Females (Group #1)
- Age 18-45 yrs inclusive
- Generally healthy
- Undergoing any scheduled surgical procedure deemed suitable by the Investigator MD
- Planned to receive the drug Ondansetron for the surgery
- Able and willing to sign the informed consent
- For Pregnant Females (Group #2)
- Age 18-45 yrs inclusive
- Term pregnancy (37 weeks through 41 wks + 6 days)
- Generally healthy (not morbidly obese)
- Undergoing a planned C-section or by an unplanned, non-urgent C-section
- Planned to receive the drug Ondansetron for the surgery
- Single birth
- Able and willing to sign the informed consent for herself \& the baby
- For the Neonatal Participant (Group #3)
- Male or female
- Viable birth
- Gestational age of 37 weeks through 41 weeks + 6 days
- Mother gave written consent for baby to participate
Exclusion
- Medical condition that would effect the metabolism of ondansetron
- Known allergy to ondansetron
- 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)
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01801475
Start Date
January 1 2013
End Date
May 1 2013
Last Update
June 1 2015
Active Locations (1)
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1
Lucile Packard Children's Hospital & Stanford Hospital
Palo Alto, California, United States, 94305