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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
This study will include a single intervention group, divided into 3 cohorts across the range of gestational ages of interest.
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Antenatal Caffeine 		A single dose of caffeine citrate will be given intravenously within approximately 1 hour prior to delivery. Caffeine and metabolite levels will be measured from blood samples drawn pre-dose and post-dose in pregnant participants, from cord blood, and from the neonate.
  • Drug: Caffeine citrate
    A single dose of 100 mg of caffeine citrate will be given to each pregnant participant.

Recruiting Locations

Riley Hospital for Children
Indianapolis, Indiana 46202
Contact:
Anna Thomas, MD
317-908-1096
aeschwar@iu.edu

More Details

Status
Recruiting
Sponsor
Indiana University

Study Contact

Anna E Thomas, MD
800-248-1199
aeschwar@iu.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.