Betamethasone and Severity of Hyaline Membrane Disease (b-Mhyalines)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Pregnant Women Receive Celesten

Study type: Observational

Funder types: Other

Identifiers

NCT01854840

NI10069

2011-A01257-34 (Other Identifier)

Details and patient eligibility

About

Primary purpose: to study the relationship between betamethasone placental transfer and the occurrence and severity of the Hyaline Membrane Disease.

Full 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.

Enrollment: 127 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

127 participants in 1 patient group

Celesten in prevention of hyaline membrane disease.

Description:

Pregnant women that received at least a first injection of Celesten in the prevention of hyaline membrane disease.