Pharmacokinetics and Placental Transfer of Caffeine

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIndiana University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Caffeine citrate

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Indiana University

Lead sponsor

Indiana Clinical and Translational Sciences Institute

Collaborator