Caffeine Study for Premature Birth and Related Conditions
Pharmacokinetics and Placental Transfer of Caffeine
Recruiting
Phase 1
Interventional Study
Preterm Labor With Preterm Delivery
Premature Birth
Apnea of Prematurity
Respiratory Distress Syndrome
Bronchopulmonary Dysplasia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Basic Science
- Participants needed
- 30 (estimated)
- Sponsor
- Indiana University · Other
Who this trial is looking for
This trial is looking for pregnant women at risk of early delivery. Participants will have a small amount of caffeine given to them, and their blood will be tested to see how caffeine is processed during pregnancy.
Are You a Good Fit for This Trial?
You may be able to join if
- I am a pregnant woman between 23 and 31 weeks along.
- I am in the hospital and will deliver soon.
- I have provided informed consent to participate.
- I will have a cesarean delivery.
You may not be able to join if
- I have major birth defects or genetic disorders in my baby.
- There is a plan for limited care for my baby after birth.
- I had my water break before 22 weeks and there are concerns for my baby's lung development.
- I have pre-eclampsia or high blood pressure during pregnancy.
- I have a fetal heart rhythm problem.
- I have a seizure disorder.
- I have low amniotic fluid due to kidney problems.
- I am under 18 years old.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 wil…
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
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…
Contacts