PreeclampsiaPREMAFENCT06232668
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
An observational study of Preeclampsia, run by Carlos Simon Foundation at 4 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?
- Maternal-fetal interface biopsy and peripheral blood collection in cases group
- Type of treatment
- Surgery or procedure
- How many people
- 2,084 participants
- Where
- 4 sitesSpain
- Study dates
- 20 Nov 2023to Dec 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
- Adult, Older adult
Study population: The study population will consist of women aged 18 years or older with singleton pregnancies who, depending on their stage of pregnancy and willingness to participate, may be enrolled in one or both phases of the study: * Phase 1 (first trimester): Women attending the participating referral centers between 9 and 15 weeks of gestation to undergo chorionic villus sampling (CVS), either due to an increased risk of fetal chromosomal abnormalities identified through non-invasive prenatal screening or for any other medical indication. In these cases, participants will be asked to donate surplus chorionic villus tissue obtained during the diagnostic procedure, as well as a peripheral blood sample. * Phase 2 (delivery): Women who, regardless of whether they participated in the initial phase of the study, agree to donate placental tissue and maternal blood samples at the time of delivery. Participation in this phase may be offered at later stages of pregnancy.
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.
- Women who meet at least one of the following criteria at the time of inclusion:
- Phase 1 (first trimester): Pregnant women between 9 and 15 weeks of gestation who are scheduled to undergo chorionic villus sampling (CVS) as part of the center's routine clinical practice.
- Phase 2 (delivery): Women with an ongoing pregnancy, regardless of gestational age and without the requirement of having participated in Phase 1, who are willing to donate placental and maternal blood samples following delivery.
Who cannot join
- Women with multiple pregnancy.
- Non-evolving pregnancies (including delayed abortion/foetal orbit).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Carlos Simón, MD, PhD contact
Spain4 sites, 4 recruiting
- Recruiting
Hospital General Universitario Dr. Balmis
Alicante, Alicante
Ana María Palacios Marqués, 965 93 30 00, ana.palacios.marques@gmail.com
- Recruiting
Hospital Clinico Universitario Virgen de la Arrixaca
Murcia, Murcia
Juan Luis Delgado, +34 968 36 96 74, juanluisdelgado@tokos.org
- Recruiting
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Santa Cruz de Tenerife
Mercedes Hernández Suárez, 922 67 80 00, mercedes021281@hotmail.com
Walter Plasencia Acevedo
- Recruiting
Hospital Universitario y Politécnico La Fe
Valencia, Valencia
Rogelio Monfort Ortiz, +34 961 24 40 00, monfort_isaort@gva.es
Beatriz Marcos Puig, +34 961 24 40 00, marcos_bea@gva.es
About this study
Official title: Molecular Study of the Maternal-fetal Interface Prospectively to the Onset of Preeclampsia Using Single Cell Technology.
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 that prevents the establishment of a functional maternal-fetal interface has been evidenced. The main objective of this study is to identify molecular markers or aberrant maternal-fetal cell types that can be detected early in the development of the disease in maternal-fetal interface tissue (chorionic villi + decidua) collected during gestational weeks 9 to 15. Maternal-fetal interface biopsy will be collected from women who have a recommendation for aneuploidy testing. The remaining fragment will be used for this study.
Read the detailed description
The hypothesis is that those women who develop PE have impaired decidualization associated with shallow cytotrophoblast invasion during the development of the maternal-fetal interface whose molecular profile analysis at the single cell level will allow characterization of PE development prior to the onset of symptoms.
The purposed study is a biomedical, prospective, multicentre, case-control aimed to characterize the molecular profile of the maternal-fetal interface in the first trimester of pregnancy early in the development of preeclampsia using single-cell sequencing technology. Distinguishing the maternal and fetal origin of the chorionic biopsy cells, describing the maternal-fetal interface and deciphering the intercellular communications and altered pathways in PE and other obstetric complications could be suggested as a secondary outcome, as well as the characterization of the blood sample, the epigenome and metabolome of single cells or the validation of markers of the different cell types. Another objective will be to perform a molecular characterization of maternal-fetal blood and tissue samples collected at the time of delivery, with the aim of correlating the alterations detected in the first trimester with the molecular profiles at the end of pregnancy in both PE patients and controls.
Subjects will be 2084 pregnant women over the age of 18 recruited between 9 and 15 gestational weeks. Patients attending the participating referral centers for a chorionic villus biopsy due to the detection of a foetal chromosomal abnormality risk will provide the leftover chorionic biopsy sample after determination of the risk of trisomies and a peripheral blood sample for genotyping of maternal lymphocytes and circulating cRNA.
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 52 months, of which the first 48 months will correspond to the recruitment period of the participants.
- Conditions
- Preeclampsia
- Being tested
- Maternal-fetal interface biopsy and peripheral blood collection in cases group, Maternal-fetal interface biopsy and peripheral blood collection in control group
- Keywords
- Preeclampsia, Early onset Preeclampsia (EOPE), First trimester, Chorionic villi, Pregnancy, Molecular study, Decidua, Maternal-fetal interface, Other pregnancy complications, Omic techniques
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal-fetal interface biopsy and peripheral blood collection in cases groupProcedure or surgery
Maternal-fetal interface tissue (chorionic villi and decidua) will be collected from women who have a recommendation for aneuploidy testing, and the remaining fragment will be used for this study and peripheral blood collection in cases group. Clinical data will be compiled.
Maternal-fetal interface biopsy and peripheral blood collection in control groupProcedure or surgery
Maternal-fetal interface tissue (chorionic villi and decidua) will be collected from women who have a recommendation for aneuploidy testing, and the remaining fragment will be used for this study and peripheral blood collection in control group. Clinical data will be compiled.
Maternal-fetal interface biopsy and peripheral blood collection in cases groupProcedure or surgery
Maternal-fetal interface tissue (placenta) and peripheral blood will be collected from women who develop preeclampsia or other obstetric complication at the end of their pregnancy. Clinical data will be compiled.
Maternal-fetal interface biopsy and peripheral blood collection in control groupProcedure or surgery
Maternal-fetal interface tissue (placenta) and peripheral blood will be collected from women who do not experience any complications or who do not experience the specific obstetric complication defined in the case group to which they are compared.
| Study group | Role | What they receive |
|---|---|---|
| Cases group (phase 1) | Women recruited between 9 and 15 gestational weeks diagnosed with preeclampsia or other complication at the end of pregnancy. Receives: Procedure: Maternal-fetal interface biopsy and peripheral blood collection in cases group | |
| Control group (phase 1) | Women recruited between 9 and 15 gestational weeks without diagnosis of preeclampsia or other complication at the end of the pregnancy Receives: Procedure: Maternal-fetal interface biopsy and peripheral blood collection in control group | |
| Cases group (phase 2) | Women recruited at delivery with preeclampsia or other complication. Receives: Procedure: Maternal-fetal interface biopsy and peripheral blood collection in cases group | |
| Control group (phase 2) | Women recruited at delivery with no obstetric complication or who do not experience the specific obstetric complication defined in the case group to which they are compared. Receives: Procedure: Maternal-fetal interface biopsy and peripheral blood collection in control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
To charactize the molecular profile of the maternal-fetal interface (chorionic billi and decidua) between 9 and 15 weeks of gestation in healthy and preeclamptic pregnancies
Differentially expressed genes between control vs preeclampsia group at the level of cell types/subtypes
Measured: From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks
Secondary outcomes (4)
To characterise the molecular profile of the maternal-fetal interface between 9 and 15 weeks of gestation in pregnancies diagnosed with pregnancy complication other than preeclampsia
Differentially expressed genes between control vs cases group at the level of cell types/subtypes.
Measured: From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks
To characterize the molecular profile of the maternal-fetal interface (placenta) at the end of pregnancy in healthy and preeclamptic pregnancies
Differentially expressed genes between control vs preeclampsia group at the level of cell types/subtypes
Measured: From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks
To characterise the epigenome and metabolome of individual cells from the maternal-fetal interface in healthy pregnancies and those diagnosed with preeclampsia or other pregnancy complication
Differentially methylation profiles and differentially metabolites between control vs cases group at the level of cell types/subtypes.
Measured: From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks
The discovery and validation of molecular markers as candidates for early diagnosis and/or therapy
Area Under the ROC Curve and/or cell type phenotyping in in vitro cultures after disrupting the candidate
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 posted31 Jan 2024
- Study start20 Nov 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
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
- 2,084 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carlos Simon Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamara Garrido, PhD, Principal investigator, Fundación Carlos Simon para la investigación en salud de la mujer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232668
- Sponsor's protocol ID
- FCS-IMF-TG-23-03
- Acronym
- PREMAFE
- Status last verified
- Nov 2026
- First submitted
- 22 Jan 2024
- Last updated
- 6 Nov 2026
- 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Study of the Maternal-fetal Interface Prospectively to the Onset of Preeclampsia Using Single Cell Technology.
- ClinicalTrials.gov ID
- NCT06232668
- Acronym / sponsor ID
- PREMAFE / FCS-IMF-TG-23-03
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, Early onset Preeclampsia (EOPE), First trimester, Chorionic villi, Pregnancy, Molecular study, Decidua, Maternal-fetal interface
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,084 participants (estimated)
- Lead sponsor
- Carlos Simon FoundationUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 Jan 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 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 that prevents the establishment of a functional maternal-fetal interface has been evidenced. The main objective of this study is to identify molecular markers or aberrant maternal-fetal cell types that can be detected early in the development of the disease in maternal-fetal interface tissue (chorionic villi + decidua) collected during gestational weeks 9 to 15. Maternal-fetal interface biopsy will be collected from women who have a recommendation for aneuploidy testing. The remaining fragment will be used for this study.
Detailed description
The hypothesis is that those women who develop PE have impaired decidualization associated with shallow cytotrophoblast invasion during the development of the maternal-fetal interface whose molecular profile analysis at the single cell level will allow characterization of PE development prior to the onset of symptoms.
The purposed study is a biomedical, prospective, multicentre, case-control aimed to characterize the molecular profile of the maternal-fetal interface in the first trimester of pregnancy early in the development of preeclampsia using single-cell sequencing technology. Distinguishing the maternal and fetal origin of the chorionic biopsy cells, describing the maternal-fetal interface and deciphering the intercellular communications and altered pathways in PE and other obstetric complications could be suggested as a secondary outcome, as well as the characterization of the blood sample, the epigenome and metabolome of single cells or the validation of markers of the different cell types. Another objective will be to perform a molecular characterization of maternal-fetal blood and tissue samples collected at the time of delivery, with the aim of correlating the alterations detected in the first trimester with the molecular profiles at the end of pregnancy in both PE patients and controls.
Subjects will be 2084 pregnant women over the age of 18 recruited between 9 and 15 gestational weeks. Patients attending the participating referral centers for a chorionic villus biopsy due to the detection of a foetal chromosomal abnormality risk will provide the leftover chorionic biopsy sample after determination of the risk of trisomies and a peripheral blood sample for genotyping of maternal lymphocytes and circulating cRNA.
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 52 months, of which the first 48 months will correspond to the recruitment period of the participants.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cases group (phase 1) | – | Procedure: Maternal-fetal interface biopsy and peripheral blood collection in cases groupWomen recruited between 9 and 15 gestational weeks diagnosed with preeclampsia or other complication at the end of pregnancy. |
| Control group (phase 1) | – | Procedure: Maternal-fetal interface biopsy and peripheral blood collection in control groupWomen recruited between 9 and 15 gestational weeks without diagnosis of preeclampsia or other complication at the end of the pregnancy |
| Cases group (phase 2) | – | Procedure: Maternal-fetal interface biopsy and peripheral blood collection in cases groupWomen recruited at delivery with preeclampsia or other complication. |
| Control group (phase 2) | – | Procedure: Maternal-fetal interface biopsy and peripheral blood collection in control groupWomen recruited at delivery with no obstetric complication or who do not experience the specific obstetric complication defined in the case group to which they are compared. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of women aged 18 years or older with singleton pregnancies who, depending on their stage of pregnancy and willingness to participate, may be enrolled in one or both phases of the study: * Phase 1 (first trimester): Women attending the participating referral centers between 9 and 15 weeks of gestation to undergo chorionic villus sampling (CVS), either due to an increased risk of fetal chromosomal abnormalities identified through non-invasive prenatal screening or for any other medical indication. In these cases, participants will be asked to donate surplus chorionic villus tissue obtained during the diagnostic procedure, as well as a peripheral blood sample. * Phase 2 (delivery): Women who, regardless of whether they participated in the initial phase of the study, agree to donate placental tissue and maternal blood samples at the time of delivery. Participation in this phase may be offered at later stages of pregnancy.
Key inclusion criteria (5 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.
- Women who meet at least one of the following criteria at the time of inclusion:
- Phase 1 (first trimester): Pregnant women between 9 and 15 weeks of gestation who are scheduled to undergo chorionic villus sampling (CVS) as part of the center's routine clinical practice.
- Phase 2 (delivery): Women with an ongoing pregnancy, regardless of gestational age and without the requirement of having participated in Phase 1, who are willing to donate placental and maternal blood samples following delivery.
Key exclusion criteria (2 listed)
- Women with multiple pregnancy.
- Non-evolving pregnancies (including delayed abortion/foetal orbit).
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 |
|---|---|---|
| Maternal-fetal interface biopsy and peripheral blood collection in cases groupMaternal-fetal interface tissue (chorionic villi and decidua) will be collected from women who have a recommendation for aneuploidy testing, and the remaining fragment will be used for this study and peripheral blood collection in cases group. Clinical data will be compiled. | Procedure or surgery | Cases group (phase 1) |
| Maternal-fetal interface biopsy and peripheral blood collection in control groupMaternal-fetal interface tissue (chorionic villi and decidua) will be collected from women who have a recommendation for aneuploidy testing, and the remaining fragment will be used for this study and peripheral blood collection in control group. Clinical data will be compiled. | Procedure or surgery | Control group (phase 1) |
| Maternal-fetal interface biopsy and peripheral blood collection in cases groupMaternal-fetal interface tissue (placenta) and peripheral blood will be collected from women who develop preeclampsia or other obstetric complication at the end of their pregnancy. Clinical data will be compiled. | Procedure or surgery | Cases group (phase 2) |
| Maternal-fetal interface biopsy and peripheral blood collection in control groupMaternal-fetal interface tissue (placenta) and peripheral blood will be collected from women who do not experience any complications or who do not experience the specific obstetric complication defined in the case group to which they are compared. | Procedure or surgery | Control group (phase 2) |
Primary outcome
To charactize the molecular profile of the maternal-fetal interface (chorionic billi and decidua) between 9 and 15 weeks of gestation in healthy and preeclamptic pregnancies
Time frame: From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks
Differentially expressed genes between control vs preeclampsia group at the level of cell types/subtypes
4 secondary outcomes
To characterise the molecular profile of the maternal-fetal interface between 9 and 15 weeks of gestation in pregnancies diagnosed with pregnancy complication other than preeclampsia
Time frame: From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks
To characterize the molecular profile of the maternal-fetal interface (placenta) at the end of pregnancy in healthy and preeclamptic pregnancies
Time frame: From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks
To characterise the epigenome and metabolome of individual cells from the maternal-fetal interface in healthy pregnancies and those diagnosed with preeclampsia or other pregnancy complication
Time frame: From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks
The discovery and validation of molecular markers as candidates for early diagnosis and/or therapy
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 6 Nov 2026.
- Individual participant dataSharing planned: No
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
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RecruitingPhase 3
Preeclampsia Intervention Netherlands
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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.
Carlos Simón, MD, PhD contact
Tamara Garrido, PhD principal investigator
Fundación Carlos Simon para la investigación en salud de la mujer
4 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 Carlos Simon Foundation at 4 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 5 inclusion and 2 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 6 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 4 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?
Contact Érika Ortiz, BSc, MSc (+34962938210, clinicalstudies@fundacioncarlossimon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To charactize the molecular profile of the maternal-fetal interface (chorionic billi and decidua) between 9 and 15 weeks of gestation in healthy and preeclamptic pregnancies (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 6 Nov 2026.