Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Location status: Recruiting
NCT Number: NCT07570121
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Phase 1
Indianapolis, Indiana, 46202, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A single dose of 100 mg of caffeine citrate will be given to each pregnant participant.
Time frame: 3 hours
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.
Time frame: 1 hour
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.
Contact information is provided by the study sponsor or research team.
Indiana University
Other
Pharmacokinetics and Placental Transfer of Caffeine: a Pilot Trial of Caffeine Administration Across the Second and Third Trimesters of Pregnancy
Acronym: AnteCaff
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05469984
Premature Rupture of Membranes Prolonged, Preterm Labor With Preterm Delivery
Nahariya, Israel
View Trial DetailsNCT05044143
Preterm Labor With Preterm Delivery
Ancona, Italy
View Trial DetailsNCT05987800
Bronchopulmonary Dysplasia, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Jette, Brussels Capital, Belgium
View Trial DetailsNCT05036603
Atelectasis Neonatal, Bronchopulmonary Dysplasia
Kahramanmaraş, Turkey (Türkiye)
View Trial Details