The goal of this study is to learn how a pregnant person's body processes caffeine and how much caffeine crosses the placenta to the baby. A small dose of caffeine will be given to each pregnant participant before delivery. Blood will be drawn to measure caffeine levels in the pregnant mother. Blood will also be taken from the placenta and from the newborn to measure caffeine levels. This data will be used to form a computer model of the metabolism of caffeine during pregnancy.
Pregnant women with risk of preterm delivery at 23 - 31+6 weeks with singleton gestation who are inpatient without a plan for discharge before delivery.
Informed consent provided for participation.
Cesarean delivery.
Known major fetal congenital anomalies or genetic disorders.
Plan in place for limited neonatal resuscitation or comfort care only.
Preterm, premature rupture of membranes prior to 22 weeks gestation with concern for pulmonary hypoplasia.
Pre-eclampsia, gestational hypertension, or other gestational hypertensive disorder.
Single group
Caffeine citrate
DrugA single dose of 100 mg of caffeine citrate will be given to each pregnant participant.
Pharmacokinetics of caffeine in pregnancy
Caffeine and primary metabolite concentrations will be determined in maternal plasma samples. Caffeine, paraxanthine, theophylline, and theobromine will be analyzed by HPLC-MS/MS (Sciex 6500) by the Indiana University Simon Comprehensive Cancer Center (IUSCCC)Clinical Pharmacology Analytical Core Laboratory. Pharmacokinetic modeling will be supported by the Indiana Clinical and Translational Sciences Institute Pharmacometric Modeling and Simulation Program. This model will be utilized to predict the maternal dose of caffeine required to achieve therapeutic concentrations in the neonate at the time of delivery.
Placental transfer of caffeine
Caffeine and primary metabolite concentrations will be determined from cord blood samples. Caffeine, paraxanthine, theophylline, and theobromine will be analyzed by HPLC-MS/MS (Sciex 6500) by the Indiana University Simon Comprehensive Cancer Center (IUSCCC) Clinical Pharmacology Analytical Core Laboratory. Maternal: cord ratios for caffeine and metabolites will be determined for each gestational age range to assess transplacental uptake and compared to predicted maternal: cord ratios determined using physiologically based pharmacokinetic (PBPK) models.
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Indiana University
Lead sponsor
Indiana Clinical and Translational Sciences Institute
Collaborator
