Preterm Labor (24 GA - 32 GA) Clinical Trial
Official title:
Markers of Fetal Membranes Remodelling in Cervicovaginal Fluid and Delivery
The investigators project aims to identify, in pregnant women, discriminating molecules to
allow an early detection of women who will spontaneously deliver prematurely, suitable in
routine clinical practice.
Human parturition is tightly correlated with hormonal changes at the maternal-fetal interface
during pregnancy, that may control cell interactions and fetal membranes (the water bag)
remodelling. Precocious remodelling may lead to a premature onset of labor, associated or not
with premature rupture of membrane whether the cause is infectious or not.
In this regard, remodelled fetal membranes overlying the cervix may discharge signals that
could be detectable in cervico-vaginal fluids and serve as biomarkers of the imminence of
delivery. Such information on delivery timing may be of great importance for an adequate
prediction that would change drastically the management of threatening preterm delivery.
Prematurity is a major Public Health concern in developed countries, since it is the first
cause of perinatal morbi-mortality and of cerebral palsy in early childhood. Premature birth
rate has risen by 36 percent over the last 25 years to reach 7.2% in 2010 in France.
Antenatal corticosteroids administration before 34 weeks and in utero transfer in
high-qualified maternity wards are ones of the rare antenatal therapies recommended to
improve neonatal complications of preterm delivery. Early identification of women with high
risk of preterm birth should be helpful to implement those prophylactic measures. Moreover
discriminating true preterm labor (PTL) vs. symptoms of PTL in women, who will finally
deliver at term, would reduce unnecessary hospitalizations and prescriptions.
During human gestation, fetal membranes (the "water bag") encompass the amnion, facing the
amniotic cavity, and the chorion, lining the maternal decidua and comprising trophoblast
cells. Membranes usually remain intact until their spontaneous rupture, close to the first
stage of labor at term. Often seen as a simple inert shell, with a role of "airbag" for the
developing fetus, the membranes provide yet a large surface of interaction between maternal
and fetal tissues and function as a transient endocrine organ with immune properties.
Specific remodelling of the membranes is observed at term prior to delivery. During this
remodelling, drastic changes in extracellular matrix occur, with the secretion of specific
molecules. The investigators hypothesize that premature fetal membranes remodelling occurs
weeks prior to actual birth and may be able to be detected in women at risk for preterm
birth, i.e. presenting signs of PTL. This study investigates if the detection of fetal
membranes remodelling in cervico-vaginal fluids can accurately identify those women at
greatest risk for preterm birth. A prospective cohort of pregnant women will before 32 weeks
of gestation with symptoms of preterm labor be enrolled. As negative controls, healthy
pregnant women at 12-15 or 35-36 weeks of gestation or non-pregnant women will be recruited.
As positive controls, healthy pregnant woman at term (over 38 weeks of gestation) will be
enrolled. The main outcome assessed is preterm delivery.
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