Betamethasone and Severity of Hyaline Membrane Disease

Completed

• Conditions: Pregnant Women Receive Celesten

• Registration Number: NCT01854840
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2012-01-12
• Study First Submitted: 2012-04-02
• Study First Submitted QC: 2013-05-15
• Study First Posted: 2013-05-16
• Primary Completion: 2017-06-30
• Study Completion: 2018-12-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 127

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Apgar score	Day 7	To study the variability of the factor " Apgar score " on fetal morbidity
mode of delivery	Day 7	To study the variability of the factor " mode of delivery" on fetal morbidity
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)
blood sample of betamethasone	Day 1 and day 2	To study the pharmacokinetics of betamethasone in all women treated
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
Optimal dose of betamethasone	Day 28	Determine the optimal dose of betamethasone necessary for the prevention of MMH, especially in infants under 28 weeks
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
sex	Day 7	To study the variability of the factor "sex" on fetal morbidity
twinning	Day 7	To study the variability of the factors "twinning" on fetal morbidity
maternal disease and treatment	Day 7	To study the variability of the factor " maternal disease and treatment on fetal morbidity

Trial Locations

Locations (1)

Necker Hospital; 🇫🇷 Paris, France