Pharmacokinetics and Placental Transfer of Caffeine: a Pilot Trial of Caffeine Administration Across the Second and Third Trimesters of Pregnancy
Indiana University
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
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 disor…
Interventions
- DrugCaffeine citrate
A single dose of 100 mg of caffeine citrate will be given to each pregnant participant.
Location
- Riley Hospital for ChildrenIndianapolis, Indiana