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Molecular Study of the Maternal-fetal Interface in Preeclampsia.

NCT ID: NCT06232668

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2084 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-20

Study Completion Date

2027-12-31

Brief Summary

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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

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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-foetal 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-foetal 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 patiens 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

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Preeclampsia

Keywords

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Preeclampsia Early onset Preeclampsia (EOPE) First trimester Chorionic villi Pregnancy Molecular study Decidua Maternal-fetal interface Other pregnancy complications Omic techniques

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cases group

Women recruited between 9 and 15 gestational weeks diagnosed with preeclampsia or other complication at the end of pregnancy.

Maternal-fetal interface biopsy and peripheral blood collection in cases group

Intervention Type PROCEDURE

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.

Control group

Women recruited between 9 and 15 gestational weeks without diagnosis of preeclampsia or other complication at the end of the pregnancy

Maternal-fetal interface biopsy and peripheral blood collection in control group

Intervention Type PROCEDURE

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.

Interventions

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Maternal-fetal interface biopsy and peripheral blood collection in cases group

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.

Intervention Type PROCEDURE

Maternal-fetal interface biopsy and peripheral blood collection in control group

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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 a single gestation between weeks 9 and 15 of gestation who will undergo a chorionic villus biopsy according to the centre's usual clinical practice.

Exclusion Criteria

* Women with multiple pregnancy.
* Non-evolving pregnancies (including delayed abortion/foetal orbit).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Carlos Simon Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tamara Garrido, PhD

Role: PRINCIPAL_INVESTIGATOR

Fundación Carlos Simon para la investigación en salud de la mujer

Locations

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Hospital General Universitario Dr. Balmis

Alicante, Alicante, Spain

Site Status RECRUITING

Hospital Universitario de Torrejón

Madrid, Madrid, Spain

Site Status NOT_YET_RECRUITING

Hospital Clinico Universitario Virgen de la Arrixaca

Murcia, Murcia, Spain

Site Status RECRUITING

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Carla Gómez, BSc, MSc

Role: CONTACT

Phone: +34962938210

Email: [email protected]

Carlos Simón, MD, PhD

Role: CONTACT

Facility Contacts

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Ana María Palacios Marqués

Role: primary

Maria del Mar Gil Mira

Role: primary

Juan Luis Delgado

Role: primary

Mercedes Hernández Suárez

Role: primary

Rogelio Monfort Ortiz

Role: primary

Beatriz Marcos Puig

Role: backup

Other Identifiers

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FCS-IMF-TG-23-03

Identifier Type: -

Identifier Source: org_study_id