Molecular Study of the Maternal-fetal Interface in Preeclampsia. (PREMAFE)
Molecular Study of the Maternal-fetal Interface Prospectively to the Onset of Preeclampsia Using Single Cell Technology.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Carlos Simón, MD, PhD
Study Contact Backup
- Name: Carla Gómez, BSc, MSc
- Phone Number: +34962938210
- Email: cgomez@fundacioncarlossimon.com
Study Locations
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Alicante
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Alicante, Alicante, Spain
- Recruiting
- Hospital General Universitario Dr. Balmis
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Contact:
- Ana María Palacios Marqués
- Phone Number: 965 93 30 00
- Email: ana.palacios.marques@gmail.com
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Madrid
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Madrid, Madrid, Spain
- Not yet recruiting
- Hospital Universitario De Torrejon
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Contact:
- Maria del Mar Gil Mira
- Phone Number: +34 916 26 26 26
- Email: mmar1984@gmail.com
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Sub-Investigator:
- Belén Santacruz Martín
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Murcia
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Murcia, Murcia, Spain
- Recruiting
- Hospital Clínico Universitario Virgen de la Arrixaca
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Contact:
- Juan Luis Delgado
- Phone Number: +34 968 36 96 74
- Email: juanluisdelgado@tokos.org
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Santa Cruz de Tenerife
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Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain
- Recruiting
- Hospital Universitario de Canarias
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Contact:
- Mercedes Hernández Suárez
- Phone Number: 922 67 80 00
- Email: mercedes021281@hotmail.com
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Sub-Investigator:
- Walter Plasencia Acevedo
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Valencia
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Valencia, Valencia, Spain
- Recruiting
- Hospital Universitario Y Politecnico La Fe
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Contact:
- Rogelio Monfort Ortiz
- Phone Number: +34 961 24 40 00
- Email: monfort_isaort@gva.es
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Contact:
- Beatriz Marcos Puig
- Phone Number: +34 961 24 40 00
- Email: marcos_bea@gva.es
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cases group
Women recruited between 9 and 15 gestational weeks diagnosed with preeclampsia or other complication at the end of pregnancy.
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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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To charactize the molecular profile of the maternal-fetal interface 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
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From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Differentially expressed genes between control vs cases 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
|
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To characterize the molecular profile of the maternal-fetal interface 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
|
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
|
|
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
|
Differentially methylation profiles and differentially metabolites between control vs cases group at the level of cell types/subtypes.
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From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks
|
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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
|
Area Under the ROC Curve and/or cell type phenotyping in in vitro cultures after disrupting the candidate
|
From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tamara Garrido, PhD, Fundación Carlos Simon para la investigación en salud de la mujer
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FCS-IMF-TG-23-03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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