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

Betamethasone and Severity of Hyaline Membrane Disease in the Newborn Premature

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

Study Overview

• Status: Completed
• Conditions: Pregnant Women Receive Celesten

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 Type: Observational
• Enrollment (Actual): 127

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Necker Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Principal Investigator: Yves Ville, MD, PhD, Necker Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2012
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: April 2, 2012
• First Submitted That Met QC Criteria: May 15, 2013
• First Posted (Estimated): May 16, 2013

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: placenta; betamethasone; hyaline membrane disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyaline Membrane Disease
• Other Study ID Numbers: NI10069; 2011-A01257-34 (Other Identifier: AFSSAPS)