Betamethasone and Severity of Hyaline Membrane Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

127 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-12

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dose Reduction of Antenatal Betamethasone Given to Prevent the Neonatal Complications Associated With Very Preterm Birth

NCT02897076

Neonatal Complications

COMPLETED PHASE3

Does a Rescue Course of Betamethasone in Pregnant Women With PPROM Decrease Neonatal Morbidity?

NCT02939742

PPROM Respiratory Distress Syndrome in Premature Infants

TERMINATED PHASE2/PHASE3

Pregnancy Outcomes in Congenital Myasthenie Syndrome

NCT01474980

Congenital Myasthenic Syndrome

COMPLETED

Study on Retroplacental Hematomas in Finistère

NCT04168606

Placental Abruption Placenta Diseases

COMPLETED

Maternal-fetal Outcomes of Genital Blood Loss Beyond 18 Weeks of Pregnancy

NCT06802874

Blood Loss

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnant Women Receive Celesten

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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