Free DNA and Nucleosome Concentrations in Pathological Pregnancies (NCT01736826) | Clinical Trial Compass
CompletedNot Applicable
Free DNA and Nucleosome Concentrations in Pathological Pregnancies
France137 participantsStarted 2015-06
Plain-language summary
The primary objective of this study is to demonstrate that plasma concentrations of nucleosomes and free DNA differ between three groups:
1. pregnant patients with complications typical of placental insufficiency or venous thrombosis (group P),
2. healthy women (Group T1) and
3. healthy pregnant women (Group T2).
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria for all patients:
* The patient must have given her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
Inclusion Criteria for patients in group P:
* The patient is pregnant and has complications typical of placental vascular disease (preeclampsia, eclampsia, HELLP syndrome, retro-placental hematoma, in utero fetal death) or venous thromboembolism (deep vein thrombosis, pulmonary embolism)
Inclusion Criteria for patients in group T1:
* The patient is available for 3 months of follow-up
* The patient is a non-pregnant healthy volunteer
* No identifiable chronic pathologies
* No history of neoplastic disease
* No history of chronic infectious disease
* No acute disease (such as benign infection), now or within the past two weeks
Inclusion Criteria for patients in group T2:
* The patient is available for 7 months of follow-up
* The patient is pregnant, with no identifiable pregnancy complications
* No identifiable chronic pathologies
* No history of neoplastic disease
* No history of chronic infectious disease
* No acute disease (such as benign infection), now or within the past two weeks
Exclusion Criteria for all patients:
* The patient is participating in another study (with the exception of the following studies: PAPILLO-PMA (2013-A00538-37), ElastoMAP (2013-A01148-37), ElastoDéclenche (2014-A00828-39), LXRs (2009-A00968-49), Bakri (2013-A00914-41), OASIS 2 (2013-A00022-43)).
* The patient is in an e…