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Pharmacokinetics and Placental Transfer of Caffeine

NCT07570121 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-06-04

No results posted yet for this study

Summary

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.

Conditions

  • Preterm Labor With Preterm Delivery
  • Premature Birth
  • Apnea of Prematurity
  • Respiratory Distress Syndrome
  • Bronchopulmonary Dysplasia

Interventions

DRUG

Caffeine citrate

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

Sponsors & Collaborators

  • Indiana Clinical and Translational Sciences Institute

    collaborator OTHER

  • Indiana University

    lead OTHER

Principal Investigators

  • Anna Thomas, MD · Indiana University, Riley Hospital for Children

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07570121 on ClinicalTrials.gov