Pharmacokinetics and Placental Transfer of Caffeine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Caffeine citrate.
- Who it may be relevant to
- Registry conditions: Preterm Labor With Preterm Delivery, Premature Birth, Apnea of Prematurity, Respiratory Distress Syndrome. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pharmacokinetics and Placental Transfer of Caffeine: a Pilot Trial of Caffeine Administration Across the Second and Third Trimesters of Pregnancy
Overview
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.
Interventions
- Drug Caffeine citrate
A single dose of 100 mg of caffeine citrate will be given to each pregnant participant.
Primary outcome measures
- Pharmacokinetics of caffeine in pregnancy [Time frame: 3 hours]
Secondary outcome measures (1)
- Placental transfer of caffeine [Time frame: 1 hour]
Eligibility criteria
Inclusion criteria
- 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.
- Informed consent provided for participation.
- Cesarean delivery.
Exclusion criteria
- Known major fetal congenital anomalies or genetic disorders.
- Plan in place for limited neonatal resuscitation or comfort care only.
- Preterm, premature rupture of membranes prior to 22 weeks gestation with concern for pulmonary hypoplasia.
- Pre-eclampsia, gestational hypertension, or other gestational hypertensive disorder.
- Fetal arrhythmia.
- Seizure disorder.
- Oligohydramnios due to renal anomalies or renal impairment.
- Current or anticipated use of products that include sodium benzoate.
- Maternal age <18 years.
- Maternal medical conditions in which caffeine or other stimulants would be contraindicated.
- High likelihood of receiving terbutaline.
- Use of the following medications, which may affect caffeine metabolism: fluvoxamine, ciprofloxacin, methoxsalen, mexiletine, vemurafenib, phenytoin, rifampin, and teriflunomide.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Riley Hospital for Children — Indianapolis
Identifiers
NCT: NCT07570121 · 27709 · 176798