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NCT01801475 · ClinicalTrials.gov registry record · Phase 1
How Pregnant Women and Their Babies Metabolize Ondansetron Compared to a Group of Non-pregnant Women
A Phase 1 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
NCT01801475: Completed Phase 1 study, sponsored by Stanford University.
NCT01801475 is a Phase 1 study that has completed, run by Stanford University. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01801475, a Phase 1 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
Study 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 pregnancy may have on the metabolism of Zofran in pregnant women or their babies. Therefore the investigators will enroll approximately 40 pregnant women and their babies and draw blood samples from the mother, the baby and the cord, to determine how much Zofran is in each sample of blood (called the pharmacokinetics or PK of Zofran). The pregnant women will receive Zofran, as a standard-of-care drug, for their scheduled Cesarean Section. The investigators will also enroll about 20 non-pregnant women undergoing surgery who will receive Zofran as standard-of-care during surgery. In both the pregnant \& the non-pregnant women, the investigators will draw blood samples at the same time points based on number of minutes from the time the Zofran is given. The blood data (PK of Zofran) will help the investigators move into Aim 2 of the study, which will be done in pregnant, narcotic-addicted mothers and their babies who are born addicted to narcotics. Aim 2 will be listed separately as it will be an interventional study.
Interventions
- DRUG Ondansetron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2013-01 |
| Est. Completion | 2013-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01801475
The ClinicalTrials.gov registry entry for NCT01801475 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ondansetron is the first listed.
NCT01801475 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01801475 about?
NCT01801475 is a clinical study titled "How Pregnant Women and Their Babies Metabolize Ondansetron Compared to a Group of Non-pregnant Women". 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 pregnancy may have on the metabolism of Zofran in pregnant women or their babies. Therefore the investigato...
What is the current status of trial NCT01801475?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2013-01. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01801475?
The interventions under investigation include: Ondansetron (DRUG).
Who is sponsoring clinical trial NCT01801475?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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