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

NCT01801475 | Completed Phase 1 Results

• 2 other identifiers: 1R01HD070795-01A1NAS Aim 1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Nausea

Keywords

Pharmacokinetics of ondansetron in women; Pharmacokinetics of ondansetron in neonates; Term pregnancy; Cesarean section

Outcome Measures

Primary Outcomes (2)

• Volume of Distribution Estimated Pharmacokinetic Parameter

  This is an estimated pharmacokinetic parameter as calculated by NONMEM.

  8 hours for women; 48 hours for neonate.

• Metabolic Clearance of Ondasetron

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

  8 hours for women; 48 hours for neonate.

Study Arms (3)

Pregnant women

ACTIVE COMPARATOR

Full term pregnant women scheduled for Cesarean section and will be given Ondansetron as standard-of-care prior to surgery.

Drug: Ondansetron

Non-pregnant women

ACTIVE COMPARATOR

Non-pregnant women scheduled for surgery at Stanford who will be given Ondansetron prior to their surgery as standard-of-care.

Drug: Ondansetron

Neonates

NO INTERVENTION

Babies of the pregnant women enrolled in the study; no ondansetron is given to babies in this "Aim 1" of the study.

Interventions

Ondansetron DRUG

Pregnant \& 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. Babies of pregnant women are not given Ondansetron but are in the study for 24-48 hours.

Also known as: Zofran

Non-pregnant women; Pregnant women

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• For Non-pregnant Females (Group #1)
• Age 18-45 yrs inclusive
• Generally healthy
• Undergoing any scheduled surgical procedure deemed suitable by the Investigator MD
• Planned to receive the drug Ondansetron for the surgery
• Able and willing to sign the informed consent
• For Pregnant Females (Group #2)
• Age 18-45 yrs inclusive
• Term pregnancy (37 weeks through 41 wks + 6 days)
• Generally healthy (not morbidly obese)
• Undergoing a planned C-section or by an unplanned, non-urgent C-section
• Planned to receive the drug Ondansetron for the surgery
• Single birth
• Able and willing to sign the informed consent for herself \& the baby
• For the Neonatal Participant (Group #3)

You may not qualify if:

• Medical condition that would effect the metabolism of ondansetron
• Known allergy to ondansetron
• 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)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital & Stanford Hospital

Palo Alto, California, 94305, United States

Location

Related Publications (1)

• Elkomy MH, Sultan P, Carvalho B, Peltz G, Wu M, Clavijo C, Galinkin JL, Drover DR. Ondansetron pharmacokinetics in pregnant women and neonates: towards a new treatment for neonatal abstinence syndrome. Clin Pharmacol Ther. 2015 Feb;97(2):167-76. doi: 10.1002/cpt.5. Epub 2014 Dec 4.

  PMID: 25670522 RESULT

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Limitations and Caveats

Since the neonate was not given a dose of study medication (ondansetron) directly it was not possible to estimate the volume of distribution in the neonate.

Results Point of Contact

• Title: Dr. David R Drover
• Organization: Stanford University

ddrover@stanford.edu

6507250364

Study Officials

• David R. Drover, MD

  Stanford University School of Medicine, Department of Anesthesia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia, Stanford School of Medicine

Study Record Dates

• First Submitted: January 28, 2013
• First Posted: February 28, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 1, 2015
• Results First Posted: June 1, 2015

Record last verified: 2015-05

Locations

US (1)