Betamethasone and Severity of Hyaline Membrane Disease

Pregnant Women Receive Celesten Clinical Trial

— b-Mhyalines  

Official title:

Betamethasone and Severity of Hyaline Membrane Disease in the Newborn Premature

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01854840
• Other study ID #: NI10069
• Secondary ID: 2011-A01257-34
• Status: Completed
• Start date: January 12, 2012
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: December 31, 2018
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyaline Membrane Disease
• Pregnant Women Receive Celesten

Locations

Country	Name	City	State
France	Necker Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of neonates with hyaline membrane disease	respiratory symptoms (respiratory rhythm disorders, signs of retraction, cyanosis, oxgen dependance >30 %). Confirmation by radiology	3 days
Secondary	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
Secondary	mode of delivery	To study the variability of the factor " mode of delivery" on fetal morbidity	Day 7
Secondary	blood sample of betamethasone	To study the pharmacokinetics of betamethasone in all women treated	Day 1 and day 2
Secondary	Optimal dose of betamethasone	Determine the optimal dose of betamethasone necessary for the prevention of MMH, especially in infants under 28 weeks	Day 28
Secondary	gestational age	To study the variability of the factors "gestational age" on fetal morbidity	Day 7
Secondary	birth weight	To study the variability of the factor " birth weight" on fetal morbidity	Day 7
Secondary	sex	To study the variability of the factor "sex" on fetal morbidity	Day 7
Secondary	Apgar score	To study the variability of the factor " Apgar score " on fetal morbidity	Day 7
Secondary	twinning	To study the variability of the factors "twinning" on fetal morbidity	Day 7
Secondary	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
Secondary	ethnicity	To study the variability of the factor "ethnicity" on fetal morbidity	Day 7
Secondary	maternal disease and treatment	To study the variability of the factor " maternal disease and treatment on fetal morbidity	Day 7