Pharmacokinetics and Placental Transfer of Caffeine: a Pilot Study of Antenatal Caffeine Administration Across the Second and Third Trimester of Pregnancy
Investigating Caffeine Transfer During Pregnancy
Anna Elizabeth Thomas
Primary Investigator
Brief description of study
Caffeine therapy is typically given to an infant to prevent apnea of prematurity shortly after birth. It is possible that giving caffeine therapy earlier, to the fetus in utero, that there is a more pronounced benefit and improvement in neonatal outcomes. This study is evaluating whether giving caffeine citrate to pregnant mothers prior to cesarean deliver will have an effect on the concentration of caffeine in umbilical cord plasma.
Detailed description of study
Maternal information to be collected will include age, weight, steroid administration, intravenous fluids, and type of anesthesia at delivery. At the time of delivery, a maternal venous sample and cord blood sample will be obtained. Neonatal data to be collected will include gestational age, birth weight, type of respiratory support needed in the delivery room, reason for intubation (if required), and timing of first caffeine dose postnatally.
Objectives:
- Evaluate the plasma concentration of caffeine in pregnant subjects following a caffeine dose near the time of delivery.
- Following maternal dosing, assess the concentration of caffeine in cord plasma at delivery.
- Estimate cord: maternal ratio and model the correct antenatal dose of caffeine citrate to reach a therapeutic concentration in the fetus to inform future antenatal caffeine studies.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Pregnancy with risk of preterm delivery, Riley
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Age: 18 years - 100 years
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Gender: Female
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 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.
This study investigates how caffeine moves from a pregnant mother to her baby during the second and third trimesters of pregnancy. The purpose of this study is to understand if giving caffeine to pregnant women before a cesarean delivery affects the amount of caffeine in the baby's umbilical cord blood. Caffeine is often given to babies after they are born to prevent breathing problems, and this study is looking at what happens if it is given earlier.
During the study, mothers will have blood samples taken, and information like age, weight, and type of anesthesia will be recorded. At delivery, a blood sample from the umbilical cord will also be collected. The study will also gather information about the baby's birth weight, gestational age, and any breathing support needed after birth. This will help understand how caffeine is transferred and processed.
- Who can participate: Pregnant women at 23 to 31 weeks of pregnancy with a single baby and at risk of preterm delivery can participate. They must be in the hospital without plans for discharge before delivery and need to agree to a cesarean delivery. Participants must provide informed consent.
- Study details: Participants will have blood samples taken and provide information on their health and delivery. A placebo will not be used in this study.
