Caffeine in pregnancy: how the mother and baby handle it during delivery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human study aims to describe the pharmacokinetics of caffeine in pregnant individuals and the placental transfer to the newborn. A small dose of caffeine citrate is administered before cesarean delivery, with blood samples collected from the mother, placenta, and newborn to measure caffeine levels. Data will be used to build a computer model of caffeine metabolism during pregnancy. The study focuses on pregnancies at risk of preterm delivery and includes carefully defined safety and eligibility criteria. Findings may inform future dosing and understanding of caffeine exposure in early life.

Why it matters

Who can join: the full rules

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 disorder.
5. Fetal arrhythmia.
6. Seizure disorder.
7. Oligohydramnios due to renal anomalies or renal impairment.
8. Current or anticipated use of products that include sodium benzoate.
9. Maternal age \<18 years.
10. Maternal medical conditions in which caffeine or other stimulants would be contraindicated.
11. High likelihood of receiving terbutaline.
12. Use of the following medications, which may affect caffeine metabolism: fluvoxamine, ciprofloxacin, methoxsalen, mexiletine, vemurafenib, phenytoin, rifampin, and teriflunomide.
13. Significant acute or chronic medical, neurologic, or illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.

Where it's running

• Riley Hospital for Children
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: Anna Thomas, MD — Indiana University, Riley Hospital for Children
• Study coordinator: Anna E Thomas, MD
• Email: aeschwar@iu.edu
• Phone: 800-248-1199

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.