Molecular Study of the Maternal-fetal Interface in Preeclampsia.

NCT06232668 | Recruiting

• 1 other identifier: FCS-IMF-TG-23-03
• Study Type: observational
• Target: 2,084
• Locations: 1 country
• Sites: 5

Brief 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. 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.

Conditions

Preeclampsia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To charactize the molecular profile of the maternal-fetal interface 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

  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

  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 at the end of pregnancy in healthy and preeclamptic pregnancies

  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

  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

  From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks

Study Arms (2)

Cases group

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

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

Control group

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

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

Interventions

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

Cases group

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women over 18 years old
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women over the age of 18 recruited between 9 and 15 gestational weeks who attend the participating referral centers for a chorionic villus biopsy due to the detection of a foetal chromosomal abnormality risk.

You may qualify if:

• 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.

You may not qualify if:

• Women with multiple pregnancy.
• Non-evolving pregnancies (including delayed abortion/foetal orbit).

Sponsors & Collaborators

• Carlos Simon Foundation: lead

Study Sites (5)

Hospital General Universitario Dr. Balmis

Alicante, Alicante, Spain

RECRUITING

Hospital Universitario de Torrejón

Madrid, Madrid, Spain

NOT YET RECRUITING

Hospital Clinico Universitario Virgen de la Arrixaca

Murcia, Murcia, Spain

RECRUITING

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain

RECRUITING

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* Maternal-fetal interface biopsy (chorionic villi + decidua) and maternal peripheral blood samples with circulating genetic material (C-RNA/C-DNA) and other biomolecules and cellular component to provide preeclampsia information and other obstetric complications. * Maternal-fetal interface tissue (placenta and decidua) and maternal peripheral blood samples containing circulating genetic material (C-RNA/C-DNA) and other biomolecules, and cellular components, to support research on preeclampsia and other obstetric complications.

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Tamara Garrido, PhD

  Fundación Carlos Simon para la investigación en salud de la mujer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carla Gómez, BSc, MSc

CONTACT

+34962938210; cgomez@fundacioncarlossimon.com

Carlos Simón, MD, PhD

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 31, 2024
• Study Start: November 20, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

ES (5)