GDMASPIRENCT07669935
Advancing Stillbirth Prevention Through Innovative Risk Evaluation (ASPIRE) Clinical Study
An observational study of GDM and Preterm Preeclampsia, run by Medicines360 at 2 sites in United States.
Trial summary
ASPIRE will be a multi-site, prospective, two-part longitudinal, noninterventional observational cohort study of nulliparous singleton pregnant women to evaluate biomarkers from blood and ocular imaging for prediction of pregnancy complications [i.e., preeclampsia (PE), fetal growth restriction (FGR), and gestational… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- GDM, Preterm Preeclampsia, Preeclampsia
- How many people
- 5,500 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Sep 2026to 1 Dec 2028
- Phase
- Observational
- 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 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Nulliparous women of child-bearing age >=18 years with singleton pregnancies exhibiting diverse demographics with racial and ethnic backgrounds representative of the general US and UK populations.
Who may be able to join
- Age ≥18 years
- Nulliparous (no previous births ≥20wk GA)
- Single viable fetus at the dating ultrasound scan with an ultrasound estimated gestational age of 10 0/7-17 6/7 weeks of gestation
- Ability to consent and comply with study procedures and follow-up
Who cannot join
- Multiple gestation
- Inability to provide blood
- Known fetal chromosomal abnormalities or structural Anomaly (a structural or functional defect with the following three characteristics: 1) of prenatal origin; 2) present at the time of live birth or fetal demise, or in utero; 3) affecting (or has the propensity to affect) the health, survival, or physical or cognitive functioning of the individual
- Known or anticipated inability to complete study follow-up through delivery at the study site (e.g., planned relocation, transfer of obstetric care to a non-participating institution, or other circumstances making delivery outcome data unavailable)
- Current or recent (within two months) participation in an interventional clinical study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Recruiting
Woman's Hospital
Baton Rouge, Louisiana, 70817
Elizabeth Sutton, 225-927-1300, Elizabeth.Sutton@womans.org
Elizabeth Sutton
- Active, not recruiting
St. Lawrence Health
Potsdam, New York, 13676
About this study
Official title: A Multi-Site, Prospective, Two-Part Longitudinal, Observational Cohort Study Of Pregnant Women To Evaluate Biomarkers For Prediction Of Pregnancy Complications
ASPIRE will be a multi-site, prospective, two-part longitudinal, noninterventional observational cohort study of nulliparous singleton pregnant women to evaluate biomarkers from blood and ocular imaging for prediction of pregnancy complications [i.e., preeclampsia (PE), fetal growth restriction (FGR), and gestational diabetes (GDM)] and risk of adverse outcomes.
- Conditions
- GDM, Preterm Preeclampsia, Preeclampsia, Fetal Growth Restriction (FGR), Pregnancy Complications
- Being tested
- None (this is an observational study with no intervention)
- Medical subject headings
- Pre-Eclampsia, Fetal Growth Retardation, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None (this is an observational study with no intervention)Other
This is an observational study evaluating biomarkers from blood and ocular imaging for prediction of pregnancy complications and associated risks [i.e., preeclampsia (PE), fetal growth restriction (FGR), and gestational diabetes (GDM)].
| Study group | Role | What they receive |
|---|---|---|
| Blood Based Biomarkers, Derivation Cohort | To support the identification of cut-offs for risk stratification for conditions such as preeclampsia, fetal growth restriction and gestational diabetes at different timepoints in gestation, in blood-based biomarker products currently in development. Receives: Other: None (this is an observational study with no intervention) | |
| Blood Based Biomarkers, Validation Cohort | To perform clinical validation of blood-based biomarkers using cut-offs at different timepoints in gestation, as defined above for identification of pregnancies at increased risk. Receives: Other: None (this is an observational study with no intervention) | |
| Retinal Imaging, Development of Algorithm | To develop a retinal imaging algorithm for risk prediction for preeclampsia. Receives: Other: None (this is an observational study with no intervention) | |
| Retinal Imaging, Validation of Algorithm | To validate the accuracy and test parameters of retinal imaging for risk prediction and management of pregnancies at risk for preeclampsia. Receives: Other: None (this is an observational study with no intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of cut-offs for risk stratification for conditions such as preeclampsia, fetal growth restriction and gestational diabetes at different timepoints in gestation.
Validation of the performance of predefined blood-based biomarkers (and/or algorithms) for prediction of PE, FGR, and GDM. Performance will be evaluated against standardized clinical phenotypes.
Measured: From enrollment to approximately 4 weeks postpartum
To perform clinical validation of blood-based biomarkers using cut-offs at different timepoints in gestation.
Validation of the performance of predefined blood-based biomarkers (and/or algorithms) for prediction of PE, FGR, and GDM. Performance will be evaluated against standardized clinical phenotypes.
Measured: From enrollment to approximately 4 weeks postpartum
To develop a retinal imaging algorithm for risk prediction for preeclampsia.
Validation of the accuracy of retinal imaging and associated algorithms for risk stratification of pre-eclampsia; specifically, performance will be evaluated in predicting preterm PE, early-onset PE, term PE, and PE with severe features.
Measured: From enrollment to approximately 4 weeks postpartum
To validate the accuracy and test parameters of retinal imaging for risk prediction and management of pregnancies at risk for preeclampsia.
Validation of the accuracy of retinal imaging and associated algorithms for risk stratification of pre-eclampsia; specifically, performance will be evaluated in predicting preterm PE, early-onset PE, term PE, and PE with severe features.
Measured: From enrollment to approximately 4 weeks postpartum
Secondary outcomes (1)
To build a database including retinal imaging and pregnancy outcome data with linked biospecimen biobank.
Measured: From enrollment to approximately 4 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start8 Sep 2026
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GDMStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medicines360
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669935
- Sponsor's protocol ID
- M360-A001
- Acronym
- ASPIRE
- Status last verified
- Sep 2026
- First submitted
- 21 Jun 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site, Prospective, Two-Part Longitudinal, Observational Cohort Study Of Pregnant Women To Evaluate Biomarkers For Prediction Of Pregnancy Complications
- ClinicalTrials.gov ID
- NCT07669935
- Acronym / sponsor ID
- ASPIRE / M360-A001
- Conditions
- GDM, Preterm Preeclampsia, Preeclampsia, Fetal Growth Restriction (FGR), Pregnancy Complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,500 participants (estimated)
- Lead sponsor
- Medicines360University, hospital or other
- Study start
- 8 Sep 2026 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 25 Jun 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.
ASPIRE will be a multi-site, prospective, two-part longitudinal, noninterventional observational cohort study of nulliparous singleton pregnant women to evaluate biomarkers from blood and ocular imaging for prediction of pregnancy complications [i.e., preeclampsia (PE), fetal growth restriction (FGR), and gestational diabetes (GDM)] and risk of adverse outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Blood Based Biomarkers, Derivation Cohort | – | Other: None (this is an observational study with no intervention)To support the identification of cut-offs for risk stratification for conditions such as preeclampsia, fetal growth restriction and gestational diabetes at different timepoints in gestation, in blood-based biomarker products currently in development. |
| Blood Based Biomarkers, Validation Cohort | – | Other: None (this is an observational study with no intervention)To perform clinical validation of blood-based biomarkers using cut-offs at different timepoints in gestation, as defined above for identification of pregnancies at increased risk. |
| Retinal Imaging, Development of Algorithm | – | Other: None (this is an observational study with no intervention)To develop a retinal imaging algorithm for risk prediction for preeclampsia. |
| Retinal Imaging, Validation of Algorithm | – | Other: None (this is an observational study with no intervention)To validate the accuracy and test parameters of retinal imaging for risk prediction and management of pregnancies at risk for preeclampsia. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Nulliparous women of child-bearing age >=18 years with singleton pregnancies exhibiting diverse demographics with racial and ethnic backgrounds representative of the general US and UK populations.
Key inclusion criteria (4 listed)
- Age ≥18 years
- Nulliparous (no previous births ≥20wk GA)
- Single viable fetus at the dating ultrasound scan with an ultrasound estimated gestational age of 10 0/7-17 6/7 weeks of gestation
- Ability to consent and comply with study procedures and follow-up
Key exclusion criteria (5 listed)
- Multiple gestation
- Inability to provide blood
- Known fetal chromosomal abnormalities or structural Anomaly (a structural or functional defect with the following three characteristics: 1) of prenatal origin; 2) present at the time of live birth or fetal demise, or in utero; 3) affecting (or has the propensity to affect) the health, survival, or physical or cognitive functioning of the individual
- Known or anticipated inability to complete study follow-up through delivery at the study site (e.g., planned relocation, transfer of obstetric care to a non-participating institution, or other circumstances making delivery outcome data unavailable)
- Current or recent (within two months) participation in an interventional clinical study.
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 |
|---|---|---|
| None (this is an observational study with no intervention)This is an observational study evaluating biomarkers from blood and ocular imaging for prediction of pregnancy complications and associated risks [i.e., preeclampsia (PE), fetal growth restriction (FGR), and gestational diabetes (GDM)]. | Other | Blood Based Biomarkers, Derivation Cohort, Blood Based Biomarkers, Validation Cohort, Retinal Imaging, Development of Algorithm, Retinal Imaging, Validation of Algorithm |
Primary outcome
Identification of cut-offs for risk stratification for conditions such as preeclampsia, fetal growth restriction and gestational diabetes at different timepoints in gestation.
Time frame: From enrollment to approximately 4 weeks postpartum
Validation of the performance of predefined blood-based biomarkers (and/or algorithms) for prediction of PE, FGR, and GDM. Performance will be evaluated against standardized clinical phenotypes.
To perform clinical validation of blood-based biomarkers using cut-offs at different timepoints in gestation.
Time frame: From enrollment to approximately 4 weeks postpartum
Validation of the performance of predefined blood-based biomarkers (and/or algorithms) for prediction of PE, FGR, and GDM. Performance will be evaluated against standardized clinical phenotypes.
To develop a retinal imaging algorithm for risk prediction for preeclampsia.
Time frame: From enrollment to approximately 4 weeks postpartum
Validation of the accuracy of retinal imaging and associated algorithms for risk stratification of pre-eclampsia; specifically, performance will be evaluated in predicting preterm PE, early-onset PE, term PE, and PE with severe features.
To validate the accuracy and test parameters of retinal imaging for risk prediction and management of pregnancies at risk for preeclampsia.
Time frame: From enrollment to approximately 4 weeks postpartum
Validation of the accuracy of retinal imaging and associated algorithms for risk stratification of pre-eclampsia; specifically, performance will be evaluated in predicting preterm PE, early-onset PE, term PE, and PE with severe features.
1 secondary outcome
To build a database including retinal imaging and pregnancy outcome data with linked biospecimen biobank.
Time frame: From enrollment to approximately 4 weeks postpartum
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 30 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GDM and Preterm Preeclampsia, run by Medicines360 at 2 sites 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 4 inclusion and 5 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 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 Carrie Fralick, MS (225-512-5546, Carie.Fralick@womans.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of cut-offs for risk stratification for conditions such as preeclampsia, fetal growth restriction and gestational diabetes at different timepoints in gestation. (time frame: From enrollment to approximately 4 weeks postpartum). The study lists 4 primary outcomes in all. 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 30 Sep 2026.