Pharmacokinetics and Placental Transfer of Caffeine (AnteCaff)

June 3, 2026 updated by: Anna Thomas, Indiana University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Anna E Thomas, MD
  • Phone Number: 800-248-1199
  • Email: aeschwar@iu.edu

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Riley Hospital for Children
        • Contact:
        • Principal Investigator:
          • Anna Thomas, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  2. Informed consent provided for participation.
  3. Cesarean delivery.

Exclusion Criteria:

  1. Known major fetal congenital anomalies or genetic disorders.
  2. Plan in place for limited neonatal resuscitation or comfort care only.
  3. Preterm, premature rupture of membranes prior to 22 weeks gestation with concern for pulmonary hypoplasia.
  4. Pre-eclampsia, gestational hypertension, or other gestational hypertensive disorder.
  5. Fetal arrhythmia.
  6. Seizure disorder.
  7. Oligohydramnios due to renal anomalies or renal impairment.
  8. Current or anticipated use of products that include sodium benzoate.
  9. Maternal age <18 years.
  10. Maternal medical conditions in which caffeine or other stimulants would be contraindicated.
  11. High likelihood of receiving terbutaline.
  12. Use of the following medications, which may affect caffeine metabolism: fluvoxamine, ciprofloxacin, methoxsalen, mexiletine, vemurafenib, phenytoin, rifampin, and teriflunomide.
  13. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Antenatal Caffeine
A single dose of caffeine citrate will be given intravenously within approximately 1 hour prior to delivery. Caffeine and metabolite levels will be measured from blood samples drawn pre-dose and post-dose in pregnant participants, from cord blood, and from the neonate.
Drug: Caffeine citrate
A single dose of 100 mg of caffeine citrate will be given to each pregnant participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

Indiana Clinical and Translational Sciences Institute

Investigators

  • Principal Investigator: Anna Thomas, MD, Indiana University, Riley Hospital for Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

April 29, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27709
  • 176798 (Other Identifier: Food and Drug Administration)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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