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New treatment option for Preterm Labor With Preterm Delivery
Official title Pharmacokinetics and Placental Transfer of Caffeine
ClinicalTrials.gov ID: NCT07570121
What this study is testing
What is Caffeine citrate?
Caffeine citrate is an investigational medicine, being studied as a potential treatment for preterm labor with preterm delivery.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Pregnant women with risk of preterm delivery at 23 - 31+6 weeks with singleton gestation who are inpatient without a plan for discharge before...
- Informed consent provided for participation.
- Cesarean delivery.
You likely can't join if
- 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.
See the full eligibility 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.