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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A01257-34 | Other Identifier | AFSSAPS |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Celesten in prevention of hyaline membrane disease. | Pregnant women that received at least a first injection of Celesten in the prevention of hyaline membrane disease. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of neonates with hyaline membrane disease | respiratory symptoms (respiratory rhythm disorders, signs of retraction, cyanosis, oxgen dependance >30 %). Confirmation by radiology | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Genetic polymorphisms | To study the pharmacogenetics of genetic polymorphisms that may affect the placental transfer of steroids (CYP-3A4, CYP-3A5, P-glycoprotein) | Day 1 |
| mode of delivery | To study the variability of the factor " mode of delivery" on fetal morbidity |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women (at one-term >27 PMA) that received at least a first injection of Celesten in the prevention of hyaline membrane disease
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| Name | Affiliation | Role |
|---|---|---|
| Yves Ville, MD, PhD | Necker Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Necker Hospital | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32394434 | Result | Foissac F, Zheng Y, Hirt D, Lui G, Bouazza N, Ville Y, Goffinet F, Rozenberg P, Kayem G, Mandelbrot L, Benaboud S, Jarreau PH, Treluyer JM. Maternal Betamethasone for Prevention of Respiratory Distress Syndrome in Neonates: Population Pharmacokinetic and Pharmacodynamic Approach. Clin Pharmacol Ther. 2020 Nov;108(5):1026-1035. doi: 10.1002/cpt.1887. Epub 2020 Jun 4. |
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| ID | Term |
|---|---|
| D006819 | Hyaline Membrane Disease |
| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Plasma samples will be collected. The effect of covariates as genetic polymorphism for CYP3A4, CYP3A5 and P-glycoprotein will be tested to explain the variability of placental transfer
| Day 7 |
| blood sample of betamethasone | To study the pharmacokinetics of betamethasone in all women treated | 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 | Day 28 |
| gestational age | To study the variability of the factors "gestational age" on fetal morbidity | Day 7 |
| birth weight | To study the variability of the factor " birth weight" on fetal morbidity | Day 7 |
| sex | To study the variability of the factor "sex" on fetal morbidity | Day 7 |
| Apgar score | To study the variability of the factor " Apgar score " on fetal morbidity | Day 7 |
| twinning | To study the variability of the factors "twinning" on fetal morbidity | 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 | Day 7 |
| ethnicity | To study the variability of the factor "ethnicity" on fetal morbidity | Day 7 |
| maternal disease and treatment | To study the variability of the factor " maternal disease and treatment on fetal morbidity | Day 7 |
| D012120 | Respiration Disorders |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |