PreeclampsiaPREMOMNCT04990141
Molecular Screening Method for Preeclampsia (PREMOM)
An observational study of Preeclampsia, run by iPremom at 15 sites in Spain.
Trial summary
Preeclampsia (PE) is a major obstetric complication with short- and long-term consequences for the mother and the fetus. Early screening tools to reduce its mortality and morbidity, as well as to prevent the life-threatening consequences are needed. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Peripheral blood collection in cases group
- Type of treatment
- Surgery or procedure
- How many people
- 9,586 participants
- Where
- 15 sitesSpain
- Study dates
- 23 Sep 2021to 27 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 women over the age of 18 recruited between 9 and 14 gestational weeks who attend the participating referral centers for their regular gynecological-obstetric follow-up, as well as their childbirth care.
Who may be able to join
- Patients whose written informed consent approved by the Ethics Committee (EC) has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved.
- Women over the age of 18 at the time of signing the informed consent form.
- Pregnant women with single gestation between weeks 9 and 14 of gestation.
Who cannot join
- Known malignancy
- History of organ transplant or bone marrow transplant.
- Maternal transfusion in the last 8 weeks prior to taking the sample.
- Early gestational loss
- Existence of serious or uncontrolled bacterial, fungal or viral infections that, in the opinion of the investigator may interfere with the patient's participation in the study or the evaluation of the results of the study.
- Other circumstances or difficulties that, in the investigator's opinion, may suppose a risk to the subject or reduce the chances of obtaining satisfactory data to achieve the objectives of the study.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
Complejo Hospitalario Universitario de Albacete
Albacete
Complejo Hospitalario Universitario Insular Materno Infantil
Albacete
Hospital General de Alicante
Alicante
Hospital Universitario Cruces
Barakaldo, Vizcaya
Hospital General Universitario Santa Lucía
Cartagena, Murcia
Hospital General de Castellón
Castellon
Hospital Universitario Reina Sofía
Córdoba
Hospital Universitario Puerta de Hierro Majadahonda
Madrid
Hospital Clinico Universitario Virgen de la Arrixaca
Murcia
Hospital Universitario de Canarias
Santa Cruz de Tenerife
Hospital Universitario de Torrejón
Torrejón de Ardoz, Madrid
Hospital Universitario y Politécnico La Fe
Valencia, Valencia
Hospital del Río Hortega
Valladolid
Hospital Clínico Universitario Lozano Blesa
Zaragoza
Hospital Universitario Miguel Servet
Zaragoza
About this study
Official title: Prospective Clinical Study for the Early Detection of Preeclampsia Based on the Molecular Screening At the First Trimester of Pregnancy
Preeclampsia (PE) is a major obstetric complication with short- and long-term consequences for the mother and the fetus. Early screening tools to reduce its mortality and morbidity, as well as to prevent the life-threatening consequences are needed. Thus, the detection of women at risk of suffering PE is key to apply preventive and treatment strategies. Recently, the maternal contribution to PE based on defective decidualization has been evidenced and new technical approaches developed to detect circulating biomolecules in blood such as RNA fragments. The main objective of this study is to evaluate the diagnostic precision of the molecular profile from the maternal blood analysed for the early screening of early onset preeclampsia (EOPE).
Read the detailed description
The hypothesis is that there is a unique molecular profile in peripheral blood specific to women who develop EOPE that allow an early assess woman´s risk of developing this pregnancy complication.
The purposed study is a biomedical, prospective, multicentre, case-control aimed to determine the predictive value and diagnostic precision of the maternal blood molecular profile for the early screening of EOPE. Late-onset preeclampsia (LOPE) and other pregnancy complications (such as preterm birth, intrauterine growth restriction, gestational diabetes, placenta previa, placental abruption, placenta accreta, premature rupture of preterm membranes, antepartum fetal death, uterine rupture and previous vasa, among others) could be analysed as a secondary outcome.
Subjects will be 9585 pregnant women recruited between 9 and 14 gestational weeks. Participants will provide peripheral blood sample at three different times during pregnancy to be characterised at molecular level in the iPremom laboratories (Igenomix Preeclampsia SLU) after their obstetric outcome was known.
Once the 50% of the total enrolment is achieved, an interim analysis will be conducted by an independent external committee. Data will be registered in an electronic Case Report Form (eCRF) specifically designed for this study. Monitoring activities and data verification will be performed during the whole study to ensure data quality, integrity and transparency.
The total estimated duration of the study is 30 months, of which the first 18 months will correspond to the recruitment period of the participants.
- Conditions
- Preeclampsia
- Being tested
- Peripheral blood collection in cases group, Peripheral blood collection in control group
- Keywords
- Preeclampsia, Early onset Preeclampsia (EOPE), Late onset Peeclampsia (LOPE), First trimester, Early screening, Circulating RNA (C-RNA), Molecular profile, Blood
- 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 collection in cases groupProcedure or surgery
Maternal peripheral blood will be collected 3 times during pregnancy (1st, 2nd and 3rd trimester) and clinical data compiled in cases group
Peripheral blood collection in control groupProcedure or surgery
Maternal peripheral blood will be collected 3 times during pregnancy (1st, 2nd and 3rd trimester) and clinical data compiled in control group
| Study group | Role | What they receive |
|---|---|---|
| Cases group | Women recruited between 9 and 14 gestational weeks diagnosed with preeclampsia or other complication at the end of pregnancy Receives: Procedure: Peripheral blood collection in cases group | |
| Control group | Women recruited between 9 and 14 gestational weeks without diagnosis of preeclampsia or other complication at the end of the pregnancy Receives: Procedure: Peripheral blood collection in control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic precision of EOPE at molecular level
Sensitivity, specificity, positive and negative predictive value using the clinical outcome of pregnancy as a "gold standard" parameter
Measured: 33 weeks
Secondary outcomes (2)
Diagnostic precision of LOPE and other pregnancy complications at molecular level
Sensitivity, specificity, positive and negative predictive value using the clinical outcome of pregnancy as a "gold standard" parameter
Measured: 33 weeks
Characterization of molecular profile in maternal blood
Molecular profile (DNA/RNA/proteins/metabolites) associated to gestational age, epidemiological and clinical variables
Measured: 33 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start23 Sep 2021
- Primary completion27 Mar 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 9,586 participants (actual)
Sponsor and investigators
- Lead sponsor
- iPremom
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tamara Garrido, PhD, Principal investigator, iPremom (Igenomix Preeclampsia SLU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990141
- Sponsor's protocol ID
- IGX1-PRE-CS-20-11
- Acronym
- PREMOM
- Status last verified
- Mar 2025
- First submitted
- 23 Jul 2021
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study for the Early Detection of Preeclampsia Based on the Molecular Screening At the First Trimester of Pregnancy
- ClinicalTrials.gov ID
- NCT04990141
- Acronym / sponsor ID
- PREMOM / IGX1-PRE-CS-20-11
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, Early onset Preeclampsia (EOPE), Late onset Peeclampsia (LOPE), First trimester, Early screening, Circulating RNA (C-RNA), Molecular profile, Blood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,586 participants (actual)
- Lead sponsor
- iPremomIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 4 Aug 2021 (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 short- and long-term consequences for the mother and the fetus. Early screening tools to reduce its mortality and morbidity, as well as to prevent the life-threatening consequences are needed. Thus, the detection of women at risk of suffering PE is key to apply preventive and treatment strategies. Recently, the maternal contribution to PE based on defective decidualization has been evidenced and new technical approaches developed to detect circulating biomolecules in blood such as RNA fragments. The main objective of this study is to evaluate the diagnostic precision of the molecular profile from the maternal blood analysed for the early screening of early onset preeclampsia (EOPE).
Detailed description
The hypothesis is that there is a unique molecular profile in peripheral blood specific to women who develop EOPE that allow an early assess woman´s risk of developing this pregnancy complication.
The purposed study is a biomedical, prospective, multicentre, case-control aimed to determine the predictive value and diagnostic precision of the maternal blood molecular profile for the early screening of EOPE. Late-onset preeclampsia (LOPE) and other pregnancy complications (such as preterm birth, intrauterine growth restriction, gestational diabetes, placenta previa, placental abruption, placenta accreta, premature rupture of preterm membranes, antepartum fetal death, uterine rupture and previous vasa, among others) could be analysed as a secondary outcome.
Subjects will be 9585 pregnant women recruited between 9 and 14 gestational weeks. Participants will provide peripheral blood sample at three different times during pregnancy to be characterised at molecular level in the iPremom laboratories (Igenomix Preeclampsia SLU) after their obstetric outcome was known.
Once the 50% of the total enrolment is achieved, an interim analysis will be conducted by an independent external committee. Data will be registered in an electronic Case Report Form (eCRF) specifically designed for this study. Monitoring activities and data verification will be performed during the whole study to ensure data quality, integrity and transparency.
The total estimated duration of the study is 30 months, of which the first 18 months will correspond to the recruitment period of the participants.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases group | – | Procedure: Peripheral blood collection in cases groupWomen recruited between 9 and 14 gestational weeks diagnosed with preeclampsia or other complication at the end of pregnancy |
| Control group | – | Procedure: Peripheral blood collection in control groupWomen recruited between 9 and 14 gestational weeks without diagnosis of preeclampsia or other complication at the end of the pregnancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women over the age of 18 recruited between 9 and 14 gestational weeks who attend the participating referral centers for their regular gynecological-obstetric follow-up, as well as their childbirth care.
Key inclusion criteria (3 listed)
- Patients whose written informed consent approved by the Ethics Committee (EC) has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved.
- Women over the age of 18 at the time of signing the informed consent form.
- Pregnant women with single gestation between weeks 9 and 14 of gestation.
Key exclusion criteria (6 listed)
- Known malignancy
- History of organ transplant or bone marrow transplant.
- Maternal transfusion in the last 8 weeks prior to taking the sample.
- Early gestational loss
- Existence of serious or uncontrolled bacterial, fungal or viral infections that, in the opinion of the investigator may interfere with the patient's participation in the study or the evaluation of the results of the 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 |
|---|---|---|
| Peripheral blood collection in cases groupMaternal peripheral blood will be collected 3 times during pregnancy (1st, 2nd and 3rd trimester) and clinical data compiled in cases group | Procedure or surgery | Cases group |
| Peripheral blood collection in control groupMaternal peripheral blood will be collected 3 times during pregnancy (1st, 2nd and 3rd trimester) and clinical data compiled in control group | Procedure or surgery | Control group |
Primary outcome
Diagnostic precision of EOPE at molecular level
Time frame: 33 weeks
Sensitivity, specificity, positive and negative predictive value using the clinical outcome of pregnancy as a "gold standard" parameter
2 secondary outcomes
Diagnostic precision of LOPE and other pregnancy complications at molecular level
Time frame: 33 weeks
Characterization of molecular profile in maternal blood
Time frame: 33 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Preeclampsia
Not yet recruitingObservational study
Blood Pressure Goal in Preterm Preeclampsia
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AtorvaStatin Postpartum and Reduction of Cardiovascular risK
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Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders
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Enrolling by invitation
MumCare: Mum's Cardiovascular Health for Life
Hypertensive Disorder of Pregnancy, Preeclampsia
RecruitingPhase 2
Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
Preeclampsia (PE), Intrauterine Growth Restriction (IUGR)
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.
Tamara Garrido, PhD principal investigator
iPremom (Igenomix Preeclampsia SLU)
15 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, run by iPremom at 15 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: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic precision of EOPE at molecular level (time frame: 33 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 25 Mar 2025; AzTrials last refreshed its copy on 26 Oct 2026.