Actively Recruiting
Pharmacokinetics and Placental Transfer of Caffeine: a Pilot Trial of Caffeine Administration Across the Second and Third Trimesters of Pregnancy
Led by Indiana University · Updated on 2026-06-04
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Indiana University
Lead Sponsor
I
Indiana Clinical and Translational Sciences Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how pregnant bodies process caffeine and how much caffeine passes through the placenta to the baby. This pilot trial focuses on pregnant women at risk of preterm delivery during the second and third trimesters. The goal is to gather data to build a computer model of caffeine metabolism during pregnancy. Participants will receive a single intravenous dose of 100 mg caffeine citrate within about one hour before delivery by cesarean section. Blood samples will be collected before and after dosing from the mother, as well as from the placenta, umbilical cord, and newborn to measure caffeine and metabolite levels. This study is designed as a phase 1 interventional trial without masking. During the trial, pregnant participants will undergo blood draws to monitor caffeine levels over three hours after dosing, and placental transfer will be measured within one hour. The study includes informed consent and monitoring for safety, with a focus on pharmacokinetics and placental transfer of caffeine. The total participation involves delivery hospitalization and sample collection timed around delivery procedures.
CONDITIONS
Brief Title
Pharmacokinetics and Placental Transfer of Caffeine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women at risk of preterm delivery between 23 and 31 weeks plus 6 days with a single baby
- Inpatient status without a plan for discharge before delivery
- Provided informed consent for participation
- Scheduled for cesarean delivery
You will not qualify if you...
- Known major fetal congenital anomalies or genetic disorders
- Plan for limited neonatal resuscitation or comfort care only
- Preterm premature rupture of membranes before 22 weeks with concern for lung underdevelopment
- Pre-eclampsia, gestational hypertension, or other gestational hypertensive disorders
- Fetal arrhythmia
- Seizure disorder
- Oligohydramnios due to kidney problems
- Current or planned use of products containing sodium benzoate
- Maternal age under 18 years
- Maternal medical conditions contraindicating caffeine or stimulants
- High likelihood of receiving terbutaline
- Use of medications affecting caffeine metabolism such as fluvoxamine, ciprofloxacin, methoxsalen, mexiletine, vemurafenib, phenytoin, rifampin, and teriflunomide
- Significant acute or chronic illness that may affect safety or study participation as judged by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Until delivery
Participants receive a single intravenous dose of caffeine citrate approximately 1 hour prior to delivery. Blood samples are collected before and after dosing to measure caffeine and metabolite levels in the mother, cord blood, and neonate.
1 treatment visit (in-person) prior to delivery
Trial Site Locations
Total: 1 location
1
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
A
Anna E Thomas, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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