Molecular Study of the Maternal-fetal Interface in Preeclampsia.
ConditionPreeclampsia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorCarlos Simon Foundation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Women with multiple pregnancy.
Non-evolving pregnancies (including delayed abortion/foetal orbit).
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Maternal-fetal interface biopsy and peripheral blood collection in cases group
Procedure/SurgeryMaternal-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 group
Procedure/SurgeryMaternal-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.
Treatment groups
2,084 Participants
are divided into 2 treatment groupsGroup A: Cases group1 intervention
Group B: Control group1 intervention
Trial outcomes
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
Time frame
From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeksSecondary outcomes
1
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.
Time frame
From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks2
To characterize the molecular profile of the maternal-fetal interface 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
Time frame
From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks3
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.
Time frame
From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeks4
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
Time frame
From the date of enrollment (minimum 9 weeks) until the end of pregnancy (maximum 43 weeks), assessed up to 34 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov