How Pregnant Women and Their Babies Metabolize Ondansetron Compared to a Group of Non-pregnant Women
Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
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.