Pre-term BirthPhase 2/3NCT07337655
Efficacy and Safety of Aspirin and Lansoprazole for Prevention of Preterm Birth in High-Risk Pregnant Women: A Biomarker-Enriched Trial
A Phase 2/3 study testing Low-Dose Aspirin Dose: 81 mg & Lansoprazole Dose: 30 mg in people with Pre-term Birth, run by Stanford University at 1 site in United States.
Trial summary
This protocol describes a seamless Phase II/III, randomized, double-blind clinical trial evaluating the efficacy and safety of daily low-dose aspirin (81 mg) plus lansoprazole (30 mg) in pregnant individuals at high risk for preterm birth when compared to existing standard of care, identified through… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pre-term Birth
- What is being tested?
- Low-Dose Aspirin Dose: 81 mg & Lansoprazole Dose: 30 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 670 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 30 Sep 2032
- Phase
- Phase 2/3
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18 to 45 years at the time of informed consent.
- Pregnancy: Singleton intrauterine pregnancy confirmed by ultrasound.
- Gestational Age: Between 12+0 and 16+6 weeks' gestation at randomization, based on first- or early second-trimester ultrasound dating.
- Risk Status: At increased risk for spontaneous preterm birth, defined by at least one of the following:
- Prior spontaneous preterm birth (<37 weeks),
- History of second-trimester pregnancy loss related to cervical insufficiency,
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- Short cervical length (≤25 mm) identified per site standard prior to randomization,
- Other clinically significant risk factors for spontaneous preterm birth as determined by the investigator.
- Biomarker Enrichment: Positive preterm birth risk classification based on serum protein signature and/or digital-twin immunologic profile, as defined in the protocol.
- General Health: In otherwise stable health, with medical conditions related to pregnancy risk permitted if well controlled.
- Informed Consent: Ability and willingness to provide written informed consent and comply with study procedures.
- Access to Care: Willingness to receive routine obstetric care at a participating study site and comply with follow-up through delivery and postpartum.
Who cannot join
- Hypersensitivity / Contraindications
- Known hypersensitivity, allergy, or intolerance to aspirin, other salicylates, lansoprazole, or other proton pump inhibitors (PPIs).
- History of aspirin-exacerbated respiratory disease (AERD), including asthma, nasal polyps, or bronchospasm triggered by aspirin or other NSAIDs.
- History of anaphylaxis or severe hypersensitivity to any component of the study drugs.
- Hematologic / Bleeding Risk
- History of major gastrointestinal bleeding, peptic ulcer hemorrhage, intracranial hemorrhage, or other serious bleeding disorder.
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- Known coagulopathy (e.g., hemophilia, von Willebrand disease) or platelet disorder relevant to aspirin use.
- Platelet count <100,000/µL at screening.
- Hemoglobin <8.0 g/dL at screening.
- Current or anticipated need for full-dose anticoagulation (e.g., therapeutic low-molecular-weight heparin) or dual antiplatelet therapy during pregnancy.
- Gastrointestinal / Hepatic / Renal
- Active peptic ulcer disease, erosive esophagitis, or known upper GI lesion at significant risk for bleeding, not adequately treated.
- History of recurrent peptic ulcer bleeding or perforation.
- Documented cirrhosis or clinically significant chronic liver disease (e.g., Child-Pugh B or C).
- Renal impairment, defined as Creatinine greater than 1.0 mg/dL, or currently on dialysis.
- Known inflammatory bowel disease with recent moderate-severe flare (e.g., requiring steroids or hospitalization in the last 3 months).
- Cardiovascular / Blood Pressure
- Persistent severe hypertension at screening (e.g., ≥160/110 mmHg on repeated measurements) not adequately controlled on therapy.
- Known significant structural heart disease or cardiomyopathy that, in the investigator's opinion, would increase risk with trial participation.
- Pregnancy-Related / Obstetric
- Multiple gestation (twins or higher-order).
- Known major fetal structural anomaly or chromosomal abnormality at screening (if results already available).
- Active preterm labor, preterm premature rupture of membranes (PPROM), or cervical dilation requiring emergent intervention at time of screening.
- Placenta previa with active bleeding or high risk of bleeding where aspirin is contraindicated.
- Planned elective termination of pregnancy.
- Current or planned participation in an obstetric intervention that would make outcome attribution to the investigational regimen impossible (per investigator judgment).
- Concomitant Medication Constraints (incl. CYP considerations)
- Chronic daily use of aspirin >81 mg/day or other antiplatelet/NSAID therapy that cannot be discontinued or adjusted to comply with the protocol.
- Current use of any PPI or H₂ blocker that cannot be safely discontinued or switched per protocol prior to randomization.
- Concomitant use of medications with a very narrow therapeutic index that are strong CYP2C19 or CYP3A4 substrates and for which modest PK changes could pose significant risk (e.g., selected anticonvulsants, calcineurin inhibitors, or antiarrhythmics), where dose adjustment or close monitoring is not feasible.
- Use of another investigational drug or device within 30 days prior to screening, or planned during the trial, that could affect maternal or fetal outcomes.
- Other Medical Conditions
- Any malignancy requiring active systemic therapy during pregnancy.
- Uncontrolled autoimmune, rheumatologic, or hematologic disease that, in the opinion of the investigator, significantly increases risk with aspirin or PPI therapy.
- Poorly controlled diabetes with significant end-organ complications (e.g., advanced nephropathy, proliferative retinopathy) where participation would add undue risk.
- Any severe or unstable systemic illness (e.g., decompensated heart failure, severe pulmonary hypertension) that, in the investigator's judgment, makes trial participation unsafe.
- Substance Use / Adherence
- Active substance use disorder (alcohol or drugs) likely to interfere with adherence, follow-up, or maternal/fetal safety.
- Any condition (including significant psychiatric illness or cognitive impairment) that, in the investigator's opinion, would compromise informed consent, adherence to study procedures, or reliable follow-up.
- Study Conduct / Ethical Considerations
- Concurrent participation in another interventional clinical trial impacting maternal-fetal outcomes.
- Prior randomization in this trial during the current pregnancy.
- Any other reason that, in the investigator's judgment, makes the participant unsuitable for the trial or at increased risk such that participation would not be in their best interest.
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
Stanford University
Palo Alto, California, 94304
Grant Wells, MS, 650-714-4344, gwells2@stanford.edu
About this study
Official title: A Phase II/III Clinical Trial Evaluating the Efficacy and Safety of Aspirin and Lansoprazole in High-Risk Pregnant Women for the Prevention of Preterm Birth: A Biomarker-Enriched Design
This protocol describes a seamless Phase II/III, randomized, double-blind clinical trial evaluating the efficacy and safety of daily low-dose aspirin (81 mg) plus lansoprazole (30 mg) in pregnant individuals at high risk for preterm birth when compared to existing standard of care, identified through biomarker-enriched screening. Participants will be enrolled between 12-16+6 weeks' gestation and followed through delivery and postpartum. The primary objective is to determine whether the investigational combination reduces the incidence of preterm birth before 37 weeks of gestation compared with placebo.
Read the detailed description
This study is a seamless Phase II/III, randomized, double-blind, biomarker-enriched clinical trial designed to evaluate the efficacy and safety of low-dose aspirin (81 mg daily) combined with lansoprazole (30 mg daily) for the prevention of preterm birth in pregnant individuals at high risk for spontaneous preterm delivery. Participants are enrolled early in pregnancy, between 12+0 and 16+6 weeks' gestation, and followed through delivery and a 6-week postpartum period.
Preterm birth remains a leading cause of neonatal morbidity and mortality, yet effective pharmacologic prevention strategies are limited, particularly following the withdrawal of 17-hydroxyprogesterone caproate. This trial addresses a critical unmet need by testing a repurposed, scalable, and globally accessible drug combination, guided by precision-medicine risk stratification rather than broad, unselected treatment.
Eligible participants are pregnant individuals aged 18 to 45 years with a singleton gestation who meet clinical high-risk criteria for preterm birth, such as a history of prior spontaneous preterm birth, cervical insufficiency, or short cervical length. All consented participants undergo biomarker screening, including a validated serum protein serological signature and/or a digital-twin immune profiling approach, to identify those at highest biological risk. Only participants who test biomarker-positive are eligible for randomization, ensuring an enriched population most likely to benefit from intervention.
Approximately 670 biomarker-positive participants will be randomized in a 1:1 ratio to one of two study arms: (1) daily aspirin plus lansoprazole in addition to standard obstetric care, or (2) standard obstetric care alone. Investigational therapy begins immediately after randomization and continues until delivery unless discontinued for safety or clinical indications. Standard obstetric care may include cervical length surveillance, vaginal progesterone, cerclage, and other guideline-based interventions, but excludes routine aspirin or proton pump inhibitor use unless clinically required outside the protocol.
The primary endpoint is the incidence of preterm birth before 37 weeks' gestation. Key secondary endpoints include preterm birth before 34 weeks, gestational age at delivery, hypertensive disorders of pregnancy, fetal growth restriction, neonatal morbidity, NICU admission, and perinatal mortality. Safety outcomes focus on maternal bleeding, gastrointestinal events, laboratory abnormalities, and serious maternal or neonatal adverse events. The study also evaluates treatment-biomarker interactions, longitudinal changes in immune and protein signatures, and concordance between predicted and observed treatment response.
The trial incorporates a group-sequential design with a pre-specified interim analysis during the Phase II portion to evaluate safety, biomarker performance, and conditional power, enabling a seamless transition to Phase III if criteria are met. Randomization is stratified by study site, prior preterm birth history, and biomarker category. Bias is minimized through centralized randomization, double blinding, standardized outcome definitions, intention-to-treat analysis, and oversight by an independent Data and Safety Monitoring Board (DSMB).
Conducted across multiple academic medical centers with expertise in maternal-fetal medicine, this study is designed not only to determine whether aspirin plus lansoprazole can reduce preterm birth, but also to generate high-quality evidence supporting a precision-guided preventive strategy. If successful, the trial has the potential to redefine pharmacologic prevention of preterm birth using safe, inexpensive, and widely available medications tailored to biologic risk.
- Conditions
- Pre-term Birth
- Being tested
- Low-Dose Aspirin Dose: 81 mg & Lansoprazole Dose: 30 mg, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Dose Aspirin Dose: 81 mg & Lansoprazole Dose: 30 mgDrug
- Low-Dose Aspirin Dose: 81 mg Route: Oral Frequency: Once daily Timing: Preferably in the evening; may be taken with food Duration: From randomization (12+0 to 16+6 weeks' gestation) until delivery Rationale: Low-dose aspirin has anti-inflammatory, antiplatelet, and placental perfusion-enhancing properties and is widely used in pregnancy for prevention of hypertensive disorders.
- Lansoprazole Dose: 30 mg Route: Oral Frequency: Once daily Timing: Preferably in the evening; may be taken with food Duration: From randomization (12+0 to 16+6 weeks' gestation) until delivery
Rationale:
Lansoprazole is a proton pump inhibitor with an established maternal-fetal safety profile. In addition to gastroprotection during aspirin therapy, it has immunomodulatory and anti-inflammatory effects that may act synergistically with aspirin to reduce pathways implicated in spontaneous preterm birth.
Standard of CareOther
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy (Aspirin & Lansoprazole) | Experimental | Aspirin \& Lansoprazole is taken once daily in the evening, preferably 30-60 minutes after dinner. Receives: Drug: Low-Dose Aspirin Dose: 81 mg & Lansoprazole Dose: 30 mg |
| Standard of Care | Other | Standard of Care Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with a diagnosis of Preterm Birth before 37+0 weeks of gestation
The primary endpoint is the incidence of preterm birth before 37+0 weeks of gestation, defined as delivery occurring at or after 20+0 and before 37+0 weeks of gestation, in biomarker-identified high-risk pregnant participants randomized to aspirin + lansoprazole versus standard of care.
Measured: At or after 20+0 and before 37+0 weeks of gestation
Secondary outcomes (4)
Incidence of preterm birth before 34+0 weeks of gestation.
Incidence of preterm birth before 34+0 weeks of gestation.
Measured: Before 34+0 weeks of gestation.
Gestational age at delivery
Gestational age at delivery, analyzed as a continuous outcome (weeks).
Measured: At delivery
Incidence of hypertensive disorders of pregnancy, including gestational hypertension, preeclampsia, and eclampsia.
Incidence of hypertensive disorders of pregnancy, including gestational hypertension, preeclampsia, and eclampsia.
Measured: At or after 20+0 and before 37+0 weeks of gestation
Incidence of fetal growth restriction
Incidence of fetal growth restriction, including:
- Small-for-gestational-age (SGA; birthweight <10th percentile),
- Low birthweight (<2500 g), and
- Very low birthweight (<1500 g).
Measured: At delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-term BirthStudies of the same condition, open and under way.
- More trials run by Stanford 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 670 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brice Gaudilliere, Stanford University
- Investigators
- Brice Gaudillière, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337655
- Sponsor's protocol ID
- 84662
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III Clinical Trial Evaluating the Efficacy and Safety of Aspirin and Lansoprazole in High-Risk Pregnant Women for the Prevention of Preterm Birth: A Biomarker-Enriched Design
- ClinicalTrials.gov ID
- NCT07337655
- Acronym / sponsor ID
- 84662
- Conditions
- Pre-term Birth
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 670 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2032 (estimated)
- First posted
- 13 Jan 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.
This protocol describes a seamless Phase II/III, randomized, double-blind clinical trial evaluating the efficacy and safety of daily low-dose aspirin (81 mg) plus lansoprazole (30 mg) in pregnant individuals at high risk for preterm birth when compared to existing standard of care, identified through biomarker-enriched screening. Participants will be enrolled between 12-16+6 weeks' gestation and followed through delivery and postpartum. The primary objective is to determine whether the investigational combination reduces the incidence of preterm birth before 37 weeks of gestation compared with placebo.
Detailed description
This study is a seamless Phase II/III, randomized, double-blind, biomarker-enriched clinical trial designed to evaluate the efficacy and safety of low-dose aspirin (81 mg daily) combined with lansoprazole (30 mg daily) for the prevention of preterm birth in pregnant individuals at high risk for spontaneous preterm delivery. Participants are enrolled early in pregnancy, between 12+0 and 16+6 weeks' gestation, and followed through delivery and a 6-week postpartum period.
Preterm birth remains a leading cause of neonatal morbidity and mortality, yet effective pharmacologic prevention strategies are limited, particularly following the withdrawal of 17-hydroxyprogesterone caproate. This trial addresses a critical unmet need by testing a repurposed, scalable, and globally accessible drug combination, guided by precision-medicine risk stratification rather than broad, unselected treatment.
Eligible participants are pregnant individuals aged 18 to 45 years with a singleton gestation who meet clinical high-risk criteria for preterm birth, such as a history of prior spontaneous preterm birth, cervical insufficiency, or short cervical length. All consented participants undergo biomarker screening, including a validated serum protein serological signature and/or a digital-twin immune profiling approach, to identify those at highest biological risk. Only participants who test biomarker-positive are eligible for randomization, ensuring an enriched population most likely to benefit from intervention.
Approximately 670 biomarker-positive participants will be randomized in a 1:1 ratio to one of two study arms: (1) daily aspirin plus lansoprazole in addition to standard obstetric care, or (2) standard obstetric care alone. Investigational therapy begins immediately after randomization and continues until delivery unless discontinued for safety or clinical indications. Standard obstetric care may include cervical length surveillance, vaginal progesterone, cerclage, and other guideline-based interventions, but excludes routine aspirin or proton pump inhibitor use unless clinically required outside the protocol.
The primary endpoint is the incidence of preterm birth before 37 weeks' gestation. Key secondary endpoints include preterm birth before 34 weeks, gestational age at delivery, hypertensive disorders of pregnancy, fetal growth restriction, neonatal morbidity, NICU admission, and perinatal mortality. Safety outcomes focus on maternal bleeding, gastrointestinal events, laboratory abnormalities, and serious maternal or neonatal adverse events. The study also evaluates treatment-biomarker interactions, longitudinal changes in immune and protein signatures, and concordance between predicted and observed treatment response.
The trial incorporates a group-sequential design with a pre-specified interim analysis during the Phase II portion to evaluate safety, biomarker performance, and conditional power, enabling a seamless transition to Phase III if criteria are met. Randomization is stratified by study site, prior preterm birth history, and biomarker category. Bias is minimized through centralized randomization, double blinding, standardized outcome definitions, intention-to-treat analysis, and oversight by an independent Data and Safety Monitoring Board (DSMB).
Conducted across multiple academic medical centers with expertise in maternal-fetal medicine, this study is designed not only to determine whether aspirin plus lansoprazole can reduce preterm birth, but also to generate high-quality evidence supporting a precision-guided preventive strategy. If successful, the trial has the potential to redefine pharmacologic prevention of preterm birth using safe, inexpensive, and widely available medications tailored to biologic risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy (Aspirin & Lansoprazole) | Experimental | Drug: Low-Dose Aspirin Dose: 81 mg & Lansoprazole Dose: 30 mgAspirin \& Lansoprazole is taken once daily in the evening, preferably 30-60 minutes after dinner. |
| Standard of Care | Other | Other: Standard of CareStandard of Care |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Age: 18 to 45 years at the time of informed consent.
- Pregnancy: Singleton intrauterine pregnancy confirmed by ultrasound.
- Gestational Age: Between 12+0 and 16+6 weeks' gestation at randomization, based on first- or early second-trimester ultrasound dating.
- Risk Status: At increased risk for spontaneous preterm birth, defined by at least one of the following:
- Prior spontaneous preterm birth (<37 weeks),
Key exclusion criteria (43 listed)
- Hypersensitivity / Contraindications
- Hematologic / Bleeding Risk
- Gastrointestinal / Hepatic / Renal
- Cardiovascular / Blood Pressure
- Pregnancy-Related / Obstetric
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 |
|---|---|---|
| Low-Dose Aspirin Dose: 81 mg & Lansoprazole Dose: 30 mg1. Low-Dose Aspirin Dose: 81 mg Route: Oral Frequency: Once daily Timing: Preferably in the evening; may be taken with food Duration: From randomization (12+0 to 16+6 weeks' gestation) until delivery Rationale: Low-dose aspirin has anti-inflammatory, antiplatelet, and placental perfusion-enhancing properties and is widely used in pregnancy for prevention of hypertensive disorders. 2. Lansoprazole Dose: 30 mg Route: Oral Frequency: Once daily Timing: Preferably in the evening; may be taken with food Duration: From randomization (12+0 to 16+6 weeks' gestation) until delivery Rationale: Lansoprazole is a proton pump inhibitor with an established maternal-fetal safety profile. In addition to gastroprotection during aspirin therapy, it has immunomodulatory and anti-inflammatory effects that may act synergistically with aspirin to reduce pathways implicated in spontaneous preterm birth. | Drug | Combination Therapy (Aspirin & Lansoprazole) |
| Standard of CareStandard of Care | Other | Standard of Care |
Primary outcome
Number of Participants with a diagnosis of Preterm Birth before 37+0 weeks of gestation
Time frame: At or after 20+0 and before 37+0 weeks of gestation
The primary endpoint is the incidence of preterm birth before 37+0 weeks of gestation, defined as delivery occurring at or after 20+0 and before 37+0 weeks of gestation, in biomarker-identified high-risk pregnant participants randomized to aspirin + lansoprazole versus standard of care.
4 secondary outcomes
Incidence of preterm birth before 34+0 weeks of gestation.
Time frame: Before 34+0 weeks of gestation.
Gestational age at delivery
Time frame: At delivery
Incidence of hypertensive disorders of pregnancy, including gestational hypertension, preeclampsia, and eclampsia.
Time frame: At or after 20+0 and before 37+0 weeks of gestation
Incidence of fetal growth restriction
Time frame: At delivery.
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 13 Jan 2026.
- Individual participant dataSharing planned: Yes
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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.
Brice Gaudillière, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Low-Dose Aspirin Dose: 81 mg & Lansoprazole Dose: 30 mg in people with Pre-term Birth, run by Stanford 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 12 inclusion and 43 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: opening soon, as of the sponsor's last update on 13 Jan 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Brice Gaudillière, MD, PhD ((650) 723-6412, gbrice@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with a diagnosis of Preterm Birth before 37+0 weeks of gestation (time frame: At or after 20+0 and before 37+0 weeks of gestation). 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 13 Jan 2026.