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NCT Number: NCT07570121

Pharmacokinetics and Placental Transfer of Caffeine

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Fetal arrhythmia.
  • Seizure disorder.
  • Oligohydramnios due to renal anomalies or renal impairment.
  • Current or anticipated use of products that include sodium benzoate.
  • Maternal age <18 years.
  • Maternal medical conditions in which caffeine or other stimulants would be contraindicated.
  • High likelihood of receiving terbutaline.
  • Use of the following medications, which may affect caffeine metabolism: fluvoxamine, ciprofloxacin, methoxsalen, mexiletine, vemurafenib, phenytoin, rifampin, and teriflunomide.
  • Significant acute or chronic medical, neurologic, or illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.

Treatment and study plan

Caffeine citrate

Drug

A single dose of 100 mg of caffeine citrate will be given to each pregnant participant.

Primary outcomes

  1. Pharmacokinetics of caffeine in pregnancy

    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.

Secondary outcomes

  1. Placental transfer of caffeine

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna E Thomas, MD

CONTACT

[email protected]

800-248-1199

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Indiana Clinical and Translational Sciences Institute

Registry information

Official study title

Pharmacokinetics and Placental Transfer of Caffeine: a Pilot Trial of Caffeine Administration Across the Second and Third Trimesters of Pregnancy

Acronym: AnteCaff

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 6, 2026
Registry last updated
Jun 4, 2026

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.

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