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.

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NCT07570121

Pharmacokinetics and Placental Transfer of Caffeine

Recruiting
PHASE1Ages 18+InterventionalBasic science
Indiana University
~30 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:Caffeine citrate

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pharmacokinetics of caffeine in pregnancy
Measured over 3 hours
Preterm Labor With Preterm Delivery
Premature Birth
Apnea of Prematurity
Respiratory Distress Syndrome
Bronchopulmonary Dysplasia
1 sites across 1 states
Indiana1
  • Anna Thomas, MD · PRINCIPAL_INVESTIGATOR · Indiana University, Riley Hospital for Children

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  • 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.