Preeclampsia (PE)iPregnosticNCT06716242
Validation of the MaiRa Preeclampsia Test for Screening Early/Late Preeclampsia in First and Second Trimesters
An observational study of Preeclampsia (PE), run by iPremom at 11 sites in Spain.
Trial summary
Preeclampsia (PE) is a major obstetric complication with severe short- and long-term consequences for both mother and fetus. Early detection is critical to mitigate PE-related morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia (PE)
- What is being tested?
- Peripheral blood collection
- Type of treatment
- Surgery or procedure
- How many people
- 7,473 participants
- Where
- 11 sitesSpain
- Study dates
- 2 Dec 2024to Jun 2027
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant patients aged 18 years or older, recruited between 9 and 14 weeks' gestation during routine obstetrical follow-ups at referral hospitals.
Who may be able to join
- Signed informed consent approved by the Ethics Committee.
- Women ≥18 years of age at consent.
- Single gestation pregnancies with first sample collection (T1) possible between 9 and 14 weeks' gestation.
Who cannot join
- Active neoplasm.
- History of organ or bone marrow transplantation.
- Maternal transfusion within 8 weeks before sample collection.
- Evidence of early pregnancy loss at consent.
- Severe, uncontrolled infections.
- Other investigator-assessed risks that could compromise participation or data quality.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Spain11 sites
Hospital Universitario A Coruña
A Coruña, La Coruña, 15006
Hospital General Universitario Dr. Balmis
Alicante, Alicante, 03010
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
Hospital Universitario Puerta del Mar
Cadiz, Cádiz, 11009
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
Hospital de Manises
Manises, Valencia, 46940
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320
Hospital Universitario de Torrejón
Torrejón de Ardoz, Madrid, 28850
Hospital Universitario Doctor Peset
Valencia, Valencia, 46017
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, 46026
Hospital Comarcal de Vinaròs
Vinaròs, Castellón, 12500
About this study
Official title: Prospective, Observational, Multicentre Study to Confirm the Performance of Molecular Screening for Early Detection of Preeclampsia
Preeclampsia (PE) is a major obstetric complication with severe short- and long-term consequences for both mother and fetus. Early detection is critical to mitigate PE-related morbidity and mortality. Effective screening tools are needed to identify women at risk, enabling timely preventive and therapeutic interventions.
Current screening methods primarily target placental biomarkers like sFLT1 and PlGF, which are limited to short-term predictions near symptom onset. Existing first-trimester assessments that incorporate maternal factors and Doppler metrics remain constrained by low sensitivity (<41%) in compliance with NICE and ACOG guidelines.
Read more
Recent advancements in cell free RNA (cf-RNA) analysis have revealed potential in first-trimester PE prediction. Findings from the PREMOM study (NCT04990141) established a molecular profile for early-onset preeclampsia (EOPE) and late-onset preeclampsia (LOPE) through cfRNA analysis, culminating in the development of the MaiRa Preeclampsia Test (Maternal Advanced and Innovative Preeclampsia Risk Assessment), which demonstrated high predictive performance for first- and second-trimester screening.
The current study hypothesizes that the MaiRa Preeclampsia Test is generalizable, maintaining its predictive accuracy in an independent cohort.
Read the detailed description
This multicentre, prospective observational study aims to validate the MaiRa Preeclampsia Test, a molecular screening tool for predicting early-onset preeclampsia (EOPE) and late-onset preeclampsia (LOPE) in the first and second trimesters of pregnancy. The study will evaluate its diagnostic accuracy, including sensitivity, specificity, predictive values, and area under the curve (AUC).
Study Design:
Duration: 40 months
- Recruitment and Sample Collection: 28 months
- Sample Analysis: 32 months
- Follow-Up: 8 months
- Statistical Analysis and Publication: 6 months Participants: 7,473 pregnant women from 12 tertiary hospitals in Spain.
Visits:
- Visit 1 (T1): 9-14 weeks' gestation (first blood sample)
- Visit 2 (T2): 15-26 weeks' gestation (second blood sample)
- Visit 3 (T3): ≥27 weeks' gestation (third blood sample)
Blood samples will be analyzed using the MaiRa Preeclampsia Test, with results correlated against obstetric outcomes as the gold standard. Data will be documented in an electronic Case Report Form (eCRF). Quality assurance will be maintained via continuous data monitoring and verification.
- Conditions
- Preeclampsia (PE)
- Being tested
- Peripheral blood collection
- Keywords
- Early Screening, First Trimester Diagnostic, Cell-Free RNA (cfRNA), Molecular Profile, Blood Biomarkers
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood collectionProcedure or surgery
Maternal peripheral blood will be collected 3 times during pregnancy (1st, 2nd and 3rd trimester) and clinical data will also be compiled.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant patients aged 18 years or older | Pregnant patients aged 18 years or older recruited between 9 and 14 weeks' gestation during routine obstetrical follow-ups at referral hospitals. Receives: Procedure: Peripheral blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the MaiRa Preeclampsia Test for first-trimester screening (9-14 weeks) of EOPE
Sensitivity, specificity, accuracy, F1-score, positive/negative predictive values, false discovery rate, AUC.
Measured: From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.
Secondary outcomes (2)
Validation of second-trimester screening (15-26 weeks) for EOPE
Sensitivity, specificity, accuracy, F1-score, positive/negative predictive values, false discovery rate, AUC.
Measured: From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.
Validation of second-trimester screening (15-26 weeks) for LOPE
Sensitivity, specificity, accuracy, F1-score, positive/negative predictive values, false discovery rate, AUC.
Measured: From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start2 Dec 2024
- 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 Preeclampsia (PE)Studies 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
- 7,473 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iPremom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Simón, MD, PhD, Principal investigator, Carlos Simon FoundationTamara Garrido, PhD, Principal investigator, iPremom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716242
- Sponsor's protocol ID
- IPR-IPR-TG-24-01
- Acronym
- iPregnostic
- Status last verified
- Nov 2026
- First submitted
- 25 Nov 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational, Multicentre Study to Confirm the Performance of Molecular Screening for Early Detection of Preeclampsia
- ClinicalTrials.gov ID
- NCT06716242
- Acronym / sponsor ID
- iPregnostic / IPR-IPR-TG-24-01
- Conditions
- Preeclampsia (PE)
- Keywords
- Early Screening, First Trimester Diagnostic, Cell-Free RNA (cfRNA), Molecular Profile, Blood Biomarkers
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 7,473 participants (estimated)
- Lead sponsor
- iPremomIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 4 Dec 2024 (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.
Preeclampsia (PE) is a major obstetric complication with severe short- and long-term consequences for both mother and fetus. Early detection is critical to mitigate PE-related morbidity and mortality. Effective screening tools are needed to identify women at risk, enabling timely preventive and therapeutic interventions.
Current screening methods primarily target placental biomarkers like sFLT1 and PlGF, which are limited to short-term predictions near symptom onset. Existing first-trimester assessments that incorporate maternal factors and Doppler metrics remain constrained by low sensitivity (<41%) in compliance with NICE and ACOG guidelines.
Recent advancements in cell free RNA (cf-RNA) analysis have revealed potential in first-trimester PE prediction. Findings from the PREMOM study (NCT04990141) established a molecular profile for early-onset preeclampsia (EOPE) and late-onset preeclampsia (LOPE) through cfRNA analysis, culminating in the development of the MaiRa Preeclampsia Test (Maternal Advanced and Innovative Preeclampsia Risk Assessment), which demonstrated high predictive performance for first- and second-trimester screening.
The current study hypothesizes that the MaiRa Preeclampsia Test is generalizable, maintaining its predictive accuracy in an independent cohort.
Detailed description
This multicentre, prospective observational study aims to validate the MaiRa Preeclampsia Test, a molecular screening tool for predicting early-onset preeclampsia (EOPE) and late-onset preeclampsia (LOPE) in the first and second trimesters of pregnancy. The study will evaluate its diagnostic accuracy, including sensitivity, specificity, predictive values, and area under the curve (AUC).
Study Design:
Duration: 40 months
- Recruitment and Sample Collection: 28 months
- Sample Analysis: 32 months
- Follow-Up: 8 months
- Statistical Analysis and Publication: 6 months Participants: 7,473 pregnant women from 12 tertiary hospitals in Spain.
Visits:
- Visit 1 (T1): 9-14 weeks' gestation (first blood sample)
- Visit 2 (T2): 15-26 weeks' gestation (second blood sample)
- Visit 3 (T3): ≥27 weeks' gestation (third blood sample)
Blood samples will be analyzed using the MaiRa Preeclampsia Test, with results correlated against obstetric outcomes as the gold standard. Data will be documented in an electronic Case Report Form (eCRF). Quality assurance will be maintained via continuous data monitoring and verification.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant patients aged 18 years or older | – | Procedure: Peripheral blood collectionPregnant patients aged 18 years or older recruited between 9 and 14 weeks' gestation during routine obstetrical follow-ups at referral hospitals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant patients aged 18 years or older, recruited between 9 and 14 weeks' gestation during routine obstetrical follow-ups at referral hospitals.
Key inclusion criteria (3 listed)
- Signed informed consent approved by the Ethics Committee.
- Women ≥18 years of age at consent.
- Single gestation pregnancies with first sample collection (T1) possible between 9 and 14 weeks' gestation.
Key exclusion criteria (6 listed)
- Active neoplasm.
- History of organ or bone marrow transplantation.
- Maternal transfusion within 8 weeks before sample collection.
- Evidence of early pregnancy loss at consent.
- Severe, uncontrolled infections.
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 |
|---|---|---|
| Peripheral blood collectionMaternal peripheral blood will be collected 3 times during pregnancy (1st, 2nd and 3rd trimester) and clinical data will also be compiled. | Procedure or surgery | Pregnant patients aged 18 years or older |
Primary outcome
Validation of the MaiRa Preeclampsia Test for first-trimester screening (9-14 weeks) of EOPE
Time frame: From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.
Sensitivity, specificity, accuracy, F1-score, positive/negative predictive values, false discovery rate, AUC.
2 secondary outcomes
Validation of second-trimester screening (15-26 weeks) for EOPE
Time frame: From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.
Validation of second-trimester screening (15-26 weeks) for LOPE
Time frame: From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.
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 Nov 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. This study is not recruiting at the moment.
Carlos Simón, MD, PhD principal investigator
Carlos Simon Foundation
Tamara Garrido, PhD principal investigator
iPremom
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia (PE), run by iPremom at 11 sites in Spain.
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 6 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the MaiRa Preeclampsia Test for first-trimester screening (9-14 weeks) of EOPE (time frame: From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks.). 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 Nov 2026.