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Completed

NCT Number: NCT01854840

Betamethasone and Severity of Hyaline Membrane Disease

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

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Key information

Conditions

Pregnant Women Receive Celesten Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hyaline Membrane Disease Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Necker Hospital

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of neonates with hyaline membrane disease

    Time frame: 3 days

    respiratory symptoms (respiratory rhythm disorders, signs of retraction, cyanosis, oxgen dependance >30 %). Confirmation by radiology

Secondary outcomes

  1. Genetic polymorphisms

    Time frame: Day 1

    To study the pharmacogenetics of genetic polymorphisms that may affect the placental transfer of steroids (CYP-3A4, CYP-3A5, P-glycoprotein)

  2. mode of delivery

    Time frame: Day 7

    To study the variability of the factor " mode of delivery" on fetal morbidity

  3. blood sample of betamethasone

    Time frame: Day 1 and day 2

    To study the pharmacokinetics of betamethasone in all women treated

  4. Optimal dose of betamethasone

    Time frame: Day 28

    Determine the optimal dose of betamethasone necessary for the prevention of MMH, especially in infants under 28 weeks

  5. gestational age

    Time frame: Day 7

    To study the variability of the factors "gestational age" on fetal morbidity

  6. birth weight

    Time frame: Day 7

    To study the variability of the factor " birth weight" on fetal morbidity

  7. sex

    Time frame: Day 7

    To study the variability of the factor "sex" on fetal morbidity

  8. Apgar score

    Time frame: Day 7

    To study the variability of the factor " Apgar score " on fetal morbidity

  9. twinning

    Time frame: Day 7

    To study the variability of the factors "twinning" on fetal morbidity

  10. time between birth and the last dose

    Time frame: Day 7

    To study the variability of the factor "time between birth and the last dose" on fetal morbidity

  11. ethnicity

    Time frame: Day 7

    To study the variability of the factor "ethnicity" on fetal morbidity

  12. maternal disease and treatment

    Time frame: Day 7

    To study the variability of the factor " maternal disease and treatment on fetal morbidity

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Betamethasone and Severity of Hyaline Membrane Disease in the Newborn Premature

Acronym: b-Mhyalines

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
May 16, 2013
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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