Pharmacokinetics and Placental Transfer of Caffeine: a Pilot Trial of Caffeine Administration Across the Second and Third Trimesters of Pregnancy
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Indiana
Riley Hospital for Children
RECRUITING
Indianapolis
Contact Information
Primary
Anna E Thomas, MD
aeschwar@iu.edu
800-248-1199
Time Frame
Start Date: 2026-06-01
Estimated Completion Date: 2027-06
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Indiana Clinical and Translational Sciences Institute
Leads: Indiana University