Clinical Pharmacokinetics of Labetalol in Pregnancy
S
Sara Quinney
Primary Investigator
Enrolling By Invitation
18 years or above
Female
Phase
N/A
10 participants needed
3 Locations
Brief description of study
What is this study about?
This study will determine how plasma concentrations of labetalol, a medication commonly used to treat hypertension in pregnancy, change during and after pregnancy and how this may impact antihypertensive therapy. The study will also evaluate exposure of fetus/neonate to labetalol through cord blood and breast milk.
Study objectives:
- Determine disposition of labetalol in cord blood and amniotic fluid at delivery
- Determine breast milk excretion and infant exposure to labetalol from breast milk
- Determine disposition of drugs in breast fed infants
THIS STUDY IS ENROLLING BY INVITATION ONLY - Pregnant individuals prescribed labetalol will be identified through Cerner, Epic, or by a treating clinician and contacted by the research team about study participation.
Detailed description of study
What will happen during the study?
- Attend several visits to the Clinical Research Center during and after pregnancy
- Provide urine and blood samples at visits and breast milk samples at postnatal visits
- Optional enrollment for participant's baby to participate in the study
- Study visits can be completed while inpatient if participant is admitted for any reason during the study period
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Healthy, Pregnancy, Pregnant
-
Age: 18 years or above
-
Gender: Female
Inclusion Criteria
• Pregnant individuals
• Prescribed and taking labetalol
• ≥ 18 years of age
Exclusion Criteria
• Diseases (e.g. hepatic failure) known to alter PK of labetalol
Updated on
29 Apr 2025.
Study ID: CPHR-IIR-LABETALOL, 18956
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