Trial Outcomes & Findings for How Pregnant Women and Their Babies Metabolize Ondansetron Compared to a Group of Non-pregnant Women (NCT NCT01801475)

Results Overview

This is an estimated pharmacokinetic parameter as calculated by NONMEM.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

100 participants

Primary outcome timeframe

8 hours for women; 48 hours for neonate.

Results posted on

2015-06-01

Participant Flow

Participant milestones

Participant milestones
Measure	Ondansetron 4 mg IV - Pregnant Ondansetron 4 mg was given intravenously prior to delivery of the infant.	Ondansetron 8 mg IV - Pregnant Ondansetron 8 mg was given intravenously prior to delivery of the infant.	Non-pregnant Women - 8 mg Ondansetron As a comparison for pharmacokinetics, a non-pregnant group was enrolled and received ondansetron. 8 mg ondansetron	Non-pregnant Women - 4 mg Ondansetron As a comparison for pharmacokinetics, a non-pregnant group was enrolled and received ondansetron. 4 mg ondansetron	Neonates The neonates became part of the subject population after birth. They were subsequently sampled for pharmacokinetic samples.
Overall Study STARTED	10	30	10	10	40
Overall Study COMPLETED	10	30	10	10	39
Overall Study NOT COMPLETED	0	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ondansetron 4 mg IV - Pregnant Ondansetron 4 mg was given intravenously prior to delivery of the infant.	Ondansetron 8 mg IV - Pregnant Ondansetron 8 mg was given intravenously prior to delivery of the infant.	Non-pregnant Women - 8 mg Ondansetron As a comparison for pharmacokinetics, a non-pregnant group was enrolled and received ondansetron. 8 mg ondansetron	Non-pregnant Women - 4 mg Ondansetron As a comparison for pharmacokinetics, a non-pregnant group was enrolled and received ondansetron. 4 mg ondansetron	Neonates The neonates became part of the subject population after birth. They were subsequently sampled for pharmacokinetic samples.
Overall Study Withdrawal by Subject	0	0	0	0	1

Baseline Characteristics

How Pregnant Women and Their Babies Metabolize Ondansetron Compared to a Group of Non-pregnant Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pregnant Women n=40 Participants Full term pregnant women scheduled for Cesarean section and will be given Ondansetron as standard-of-care prior to surgery. Ondansetron: Pregnant women will receive either 4mg or 8mg of Ondansetron (IV) once prior to surgical procedure (open-label). Women are in the study for 8 hours.	Non-pregnant Women n=20 Participants Non-pregnant women scheduled for surgery at Stanford who will be given Ondansetron prior to their surgery as standard-of-care. Ondansetron: non-pregnant women will receive either 4mg or 8mg of Ondansetron (IV) once prior to surgical procedure (open-label). Women are in the study for 8 hours.	Neonates n=39 Participants Babies of the pregnant women enrolled in the study; no ondansetron is given to babies in this "Aim 1" of the study. Babies of pregnant women are not given Ondansetron but are in the study for 24-48 hours.	Total n=99 Participants Total of all reporting groups
Age, Continuous	33 years STANDARD_DEVIATION 5.2 • n=5 Participants	37.7 years STANDARD_DEVIATION 5.7 • n=7 Participants	0.003 years STANDARD_DEVIATION 0.001 • n=5 Participants	35 years STANDARD_DEVIATION 5.3 • n=4 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants	80 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	19 Participants n=5 Participants	19 Participants n=4 Participants
Region of Enrollment United States	40 participants n=5 Participants	20 participants n=7 Participants	39 participants n=5 Participants	99 participants n=4 Participants

PRIMARY outcome

Timeframe: 8 hours for women; 48 hours for neonate.

Population: All subjects but not possible for neonates

This is an estimated pharmacokinetic parameter as calculated by NONMEM.

Outcome measures

Outcome measures
Measure	Women - Pregnant/Non-pregnant n=60 Participants Ondansetron 4 mg or 8mg was given intravenously prior to delivery of her baby in pregnant women and was given to age similar women in the non-pregnant group.	Neonates n=39 Participants The neonates became part of the subject population after birth. They were subsequently sampled for pharmacokinetic samples.
Volume of Distribution Estimated Pharmacokinetic Parameter	27.9 Liters Interval 18.5 to 37.3	NA Liters Sampling schedule and dose route would not allow mathematical estimation.

PRIMARY outcome

Timeframe: 8 hours for women; 48 hours for neonate.

Population: All patient data was used in the estimation process.

This is a mathematical estimation of the clearance for ondasetron as calculated by NONMEM.