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: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Ondansetron

Criteria

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)