Primary purpose: to study the relationship between betamethasone placental transfer and the occurrence and severity of the Hyaline Membrane Disease.
β-Mhyalines is a prospective multicentric non interventional study. One hundred fifty pregnant women at risk of premature delivery, in the framework of Hyaline Membrane Disease of the neonate, will receive 2 intramuscular injections of Celesten (betamethasone) at 24 hours interval. Plasma samples will be collected: 2 in the mother before delivery, one maternal and one cord samples at delivery. Concentrations will be measured and analyzed using a population approach. A ratio between neonatal and maternal exposure will be calculated to represent placental transfer. The effect of covariates (genetic polymorphism for CYP3A4, CYP3A5, P-glycoprotein…, and others variables as gestational age, bodyweight at birth, apgar score, co-medication, maternal disease) will be tested to explain the variability of placental transfer. The relationship between placental transfer and the occurrence and severity of the Hyaline Membrane Disease will then be study, in order to target betamethasone maternal concentration and thus to optimize the antenatal dose to administer to the mother in the framework of Hyaline Membrane Disease.
Study Type
OBSERVATIONAL
Enrollment
127
Necker Hospital
Paris, France
Number of neonates with hyaline membrane disease
respiratory symptoms (respiratory rhythm disorders, signs of retraction, cyanosis, oxgen dependance \>30 %). Confirmation by radiology
Time frame: 3 days
Genetic polymorphisms
To study the pharmacogenetics of genetic polymorphisms that may affect the placental transfer of steroids (CYP-3A4, CYP-3A5, P-glycoprotein)
Time frame: Day 1
mode of delivery
To study the variability of the factor " mode of delivery" on fetal morbidity
Time frame: Day 7
blood sample of betamethasone
To study the pharmacokinetics of betamethasone in all women treated
Time frame: Day 1 and day 2
Optimal dose of betamethasone
Determine the optimal dose of betamethasone necessary for the prevention of MMH, especially in infants under 28 weeks
Time frame: Day 28
gestational age
To study the variability of the factors "gestational age" on fetal morbidity
Time frame: Day 7
birth weight
To study the variability of the factor " birth weight" on fetal morbidity
Time frame: Day 7
sex
To study the variability of the factor "sex" on fetal morbidity
Time frame: Day 7
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Apgar score
To study the variability of the factor " Apgar score " on fetal morbidity
Time frame: Day 7
twinning
To study the variability of the factors "twinning" on fetal morbidity
Time frame: Day 7
time between birth and the last dose
To study the variability of the factor "time between birth and the last dose" on fetal morbidity
Time frame: Day 7
ethnicity
To study the variability of the factor "ethnicity" on fetal morbidity
Time frame: Day 7
maternal disease and treatment
To study the variability of the factor " maternal disease and treatment on fetal morbidity
Time frame: Day 7