Caffeine Citrate for Preterm Labor and Delivery
This study is looking at how a pregnant person's body handles caffeine citrate and how much of it reaches the baby. We want to understand how caffeine moves through the body during pregnancy. Each pregnant participant will receive a single dose of 100 mg of caffeine citrate before delivery. Blood samples will be taken from the pregnant mother, the placenta, and the newborn to measure caffeine levels. This information will help us create a computer model of how caffeine is processed during pregnancy. You may be able to join if you are a pregnant woman, 18 years or older, with a risk of preterm delivery between 23 and 31 weeks and 6 days of pregnancy, and are staying in the hospital until delivery. The study is currently unclear on its recruitment status.
- Study design
- This is an interventional study planning to enroll 30 pregnant women. Each participant will receive a single dose of caffeine citrate.
- What's involved
- You would receive a single dose of caffeine citrate. Blood samples would be taken from you, the placenta, and your newborn.
- Compensation
- Not stated in the trial record.
- Follow-up
- Caffeine levels will be measured at 3 hours after administration, which is the primary endpoint time frame.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pharmacokinetics and Placental Transfer of Caffeine
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Anna Thomas, MD · PRINCIPAL_INVESTIGATOR · Indiana University, Riley Hospital for Children
Who to contact
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What this trial measures
- Pharmacokinetics of caffeine in pregnancy3 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.