Clinical trial NCT01854840: Betamethasone and Severity of Hyaline Membrane Disease
Official title: Betamethasone and Severity of Hyaline Membrane Disease in the Newborn Premature
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnant Women Receive Celesten
Keywords: hyaline membrane disease
placenta
betamethasone
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 127
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women (at one-term \>27 PMA) that received at least a first injection of Celesten in the prevention of hyaline membrane disease

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of neonates with hyaline membrane disease
timeFrame: 3 days
Secondary outcomes:
measure: Genetic polymorphisms
timeFrame: Day 1
measure: mode of delivery
timeFrame: Day 7
measure: blood sample of betamethasone
timeFrame: Day 1 and day 2
measure: Optimal dose of betamethasone
timeFrame: Day 28
measure: gestational age
timeFrame: Day 7
measure: birth weight
timeFrame: Day 7
measure: sex
timeFrame: Day 7
measure: Apgar score
timeFrame: Day 7
measure: twinning
timeFrame: Day 7
measure: time between birth and the last dose
timeFrame: Day 7
measure: ethnicity
timeFrame: Day 7
measure: maternal disease and treatment
timeFrame: Day 7
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker Hospital
Study officials:
affiliation: Necker Hospital
name: Yves Ville, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: