Caffeine Metabolism During Pregnancy

(AnteCaff Trial)

The trial aims to understand how pregnant women process caffeine (specifically caffeine citrate) and how much reaches the baby. Participants will receive a small caffeine dose before delivery, and researchers will take blood samples from the mother, placenta, and newborn to measure caffeine levels. This research will help build a computer model of caffeine metabolism during pregnancy. The trial seeks pregnant women at risk of preterm delivery who are scheduled for a cesarean. As a Phase 1 trial, this research focuses on understanding caffeine citrate's effects in pregnant women, offering participants the opportunity to contribute to groundbreaking knowledge.

Yes, you may need to stop taking certain medications that affect caffeine metabolism, such as fluvoxamine, ciprofloxacin, and others listed in the exclusion criteria.

Studies have shown that caffeine citrate is generally safe during pregnancy when consumed in moderation. Research indicates that consuming less than 200 mg of caffeine daily does not significantly increase the risk of issues like miscarriage or early birth. Caffeine is a common part of many diets, and small amounts are usually well-tolerated.

Caffeine citrate has also been studied in premature babies with breathing issues, such as apnea (when they stop breathing for short periods). One study found it safe even at higher doses than usually recommended.

Researchers are excited about caffeine citrate as a treatment during pregnancy because it offers a new approach to understanding caffeine metabolism in both the mother and the neonate. Unlike traditional uses of caffeine citrate, which are typically focused on treating conditions like apnea in premature infants, this study investigates its impact when administered intravenously to pregnant women just before delivery. This unique timing allows researchers to measure caffeine and its metabolites' transfer from mother to baby, potentially providing insights into its safety and effects during this critical period. By exploring this novel use and method of administration, researchers hope to gather valuable data that could influence future recommendations for caffeine intake during pregnancy.

Research has shown that caffeine citrate is often used in newborn care, particularly to treat apnea of prematurity, a condition where premature babies temporarily stop breathing. Studies have found that it can reduce the risk of bronchopulmonary dysplasia and improve survival rates in very low birth weight babies. Caffeine citrate remains in newborns' systems longer than in adults. However, the effects of caffeine during pregnancy are complex. Some research suggests that even small amounts can slow fetal growth and affect blood flow to the placenta. This trial will administer a single dose of caffeine citrate intravenously to pregnant participants approximately one hour before delivery to study its metabolism. These findings underscore the importance of carefully monitoring caffeine levels during pregnancy.¹²⁶⁷⁸