Pregnant Women Receive Celesten
Conditions
Keywords
hyaline membrane disease, placenta, betamethasone
Brief summary
Primary purpose: to study the relationship between betamethasone placental transfer and the occurrence and severity of the Hyaline Membrane Disease.
Detailed description
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.
Interventions
None listed
Sponsors
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pregnant women who received at least a first injection of Celesten in the prevention of MMH. * A one-term\> 27 SA, * Major Patients \> or = 18 years old * Informed Consent Form signed
Exclusion criteria
* Patients undergoing treatment with corticosteroids in the long term
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of neonates with hyaline membrane disease | 3 days | respiratory symptoms (respiratory rhythm disorders, signs of retraction, cyanosis, oxgen dependance \>30 %). Confirmation by radiology |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Genetic polymorphisms | Day 1 | To study the pharmacogenetics of genetic polymorphisms that may affect the placental transfer of steroids (CYP-3A4, CYP-3A5, P-glycoprotein) |
| mode of delivery | Day 7 | To study the variability of the factor " mode of delivery" on fetal morbidity |
| blood sample of betamethasone | Day 1 and day 2 | To study the pharmacokinetics of betamethasone in all women treated |
| Optimal dose of betamethasone | Day 28 | Determine the optimal dose of betamethasone necessary for the prevention of MMH, especially in infants under 28 weeks |
| gestational age | Day 7 | To study the variability of the factors "gestational age" on fetal morbidity |
| birth weight | Day 7 | To study the variability of the factor " birth weight" on fetal morbidity |
| sex | Day 7 | To study the variability of the factor "sex" on fetal morbidity |
| Apgar score | Day 7 | To study the variability of the factor " Apgar score " on fetal morbidity |
| twinning | Day 7 | To study the variability of the factors "twinning" on fetal morbidity |
| time between birth and the last dose | Day 7 | To study the variability of the factor "time between birth and the last dose" on fetal morbidity |
| ethnicity | Day 7 | To study the variability of the factor "ethnicity" on fetal morbidity |
| maternal disease and treatment | Day 7 | To study the variability of the factor " maternal disease and treatment on fetal morbidity |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORYves Ville, MD, PhD
Necker Hospital
Outcome results
None listed