Preterm Labor With Preterm DeliveryPhase 1AnteCaffNCT07570121
Pharmacokinetics and Placental Transfer of Caffeine
A Phase 1 study testing Caffeine citrate in people with Preterm Labor With Preterm Delivery and Premature Birth, run by Indiana University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Labor With Preterm Delivery, Premature Birth, Apnea of Prematurity
- What is being tested?
- Caffeine citrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Riley Hospital for Children
Indianapolis, Indiana, 46202
Anna Thomas, MD, 317-908-1096, aeschwar@iu.edu
Anna Thomas, MD
About this study
Official title: Pharmacokinetics and Placental Transfer of Caffeine: a Pilot Trial of Caffeine Administration Across the Second and Third Trimesters of Pregnancy
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
- Preterm Labor With Preterm Delivery, Premature Birth, Apnea of Prematurity, Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
- Being tested
- Caffeine citrate
- Keywords
- caffeine, preterm labor, prematurity, pharmacokinetics, bronchopulmonary dysplasia, apnea of prematurity
- Medical subject headings
- Premature Birth, Apnea, Respiratory Distress Syndrome, Bronchopulmonary Dysplasia, Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine citrateDrug
A single dose of 100 mg of caffeine citrate will be given to each pregnant participant.
| Study group | Role | What they receive |
|---|---|---|
| Antenatal Caffeine | Other | 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. Receives: Drug: Caffeine citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of caffeine in pregnancy
Caffeine and primary metabolite concentrations will be determined in maternal plasma samples. Caffeine, paraxanthine, theophylline, and theobromine will be analyzed by HPLC-MS/MS (Sciex 6500) by the Indiana University Simon Comprehensive Cancer Center (IUSCCC)Clinical Pharmacology Analytical Core Laboratory. Pharmacokinetic modeling will be supported by the Indiana Clinical and Translational Sciences Institute Pharmacometric Modeling and Simulation Program. This model will be utilized to predict the maternal dose of caffeine required to achieve therapeutic concentrations in the neonate at the time of delivery.
Measured: 3 hours
Secondary outcomes (1)
Placental transfer of caffeine
Caffeine and primary metabolite concentrations will be determined from cord blood samples. Caffeine, paraxanthine, theophylline, and theobromine will be analyzed by HPLC-MS/MS (Sciex 6500) by the Indiana University Simon Comprehensive Cancer Center (IUSCCC) Clinical Pharmacology Analytical Core Laboratory. Maternal: cord ratios for caffeine and metabolites will be determined for each gestational age range to assess transplacental uptake and compared to predicted maternal: cord ratios determined using physiologically based pharmacokinetic (PBPK) models.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Jun 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Labor With Preterm DeliveryStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study will include a single intervention group, divided into 3 cohorts across the range of gestational ages of interest.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana Clinical and Translational Sciences Institute
- Responsible party
- Principal investigator, Anna Thomas, Indiana University
- Investigators
- Anna Thomas, MD, Principal investigator, Indiana University, Riley Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570121
- Sponsor's protocol ID
- 27709
- Other IDs
- 176798
- Acronym
- AnteCaff
- Status last verified
- Jun 2026
- First submitted
- 21 Apr 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Placental Transfer of Caffeine: a Pilot Trial of Caffeine Administration Across the Second and Third Trimesters of Pregnancy
- ClinicalTrials.gov ID
- NCT07570121
- Acronym / sponsor ID
- AnteCaff / 27709
- Conditions
- Preterm Labor With Preterm Delivery, Premature Birth, Apnea of Prematurity, Respiratory Distress Syndrome, Bronchopulmonary Dysplasia
- Keywords
- caffeine, preterm labor, prematurity, pharmacokinetics, bronchopulmonary dysplasia, apnea of prematurity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Indiana Clinical and Translational Sciences Institute
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will include a single intervention group, divided into 3 cohorts across the range of gestational ages of interest.
| Arm | Type | Receives |
|---|---|---|
| Antenatal Caffeine | Other | Drug: Caffeine citrateA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine citrateA single dose of 100 mg of caffeine citrate will be given to each pregnant participant. | Drug | Antenatal Caffeine |
Primary outcome
Pharmacokinetics of caffeine in pregnancy
Time frame: 3 hours
Caffeine and primary metabolite concentrations will be determined in maternal plasma samples. Caffeine, paraxanthine, theophylline, and theobromine will be analyzed by HPLC-MS/MS (Sciex 6500) by the Indiana University Simon Comprehensive Cancer Center (IUSCCC)Clinical Pharmacology Analytical Core Laboratory. Pharmacokinetic modeling will be supported by the Indiana Clinical and Translational Sciences Institute Pharmacometric Modeling and Simulation Program. This model will be utilized to predict the maternal dose of caffeine required to achieve therapeutic concentrations in the neonate at the time of delivery.
1 secondary outcome
Placental transfer of caffeine
Time frame: 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Thomas, MD principal investigator
Indiana University, Riley Hospital for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Caffeine citrate in people with Preterm Labor With Preterm Delivery and Premature Birth, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna E Thomas, MD (800-248-1199, aeschwar@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of caffeine in pregnancy (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.