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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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher). 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.
Primary Outcome
This is an estimated pharmacokinetic parameter as calculated by NONMEM.
Interventions
- DRUG Ondansetron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2013-01 |
| Est. Completion | 2013-05 |
| Phase | Phase 1 |
What the finished NCT01801475 record still lists
NCT01801475 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher).
The record links to 0 conditions, and to 1 intervention - of which Ondansetron is the first listed.
NCT01801475 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01801475's enrollment target sits among peer trials
100 546th of 2000 higher than 1,411 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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