Pregnant Women Receive Celestenb-MhyalinesNCT01854840
Betamethasone and Severity of Hyaline Membrane Disease
An observational study of Pregnant Women Receive Celesten, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Primary purpose: to study the relationship between betamethasone placental transfer and the occurrence and severity of the Hyaline Membrane Disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnant Women Receive Celesten
- Type of treatment
- Injection or infusion
- How many people
- 127 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2012to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients undergoing treatment with corticosteroids in the long term
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnant Women Receive Celesten
- Keywords
- hyaline membrane disease, placenta, betamethasone
- Medical subject headings
- Hyaline Membrane Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Number of neonates with hyaline membrane disease
respiratory symptoms (respiratory rhythm disorders, signs of retraction, cyanosis, oxgen dependance >30 %). Confirmation by radiology
Measured: 3 days
Secondary outcomes (12)
Genetic polymorphisms
To study the pharmacogenetics of genetic polymorphisms that may affect the placental transfer of steroids (CYP-3A4, CYP-3A5, P-glycoprotein)
Measured: Day 1
mode of delivery
To study the variability of the factor " mode of delivery" on fetal morbidity
Measured: Day 7
blood sample of betamethasone
To study the pharmacokinetics of betamethasone in all women treated
Measured: 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
Measured: Day 28
gestational age
To study the variability of the factors "gestational age" on fetal morbidity
Measured: Day 7
birth weight
To study the variability of the factor " birth weight" on fetal morbidity
Measured: Day 7
sex
To study the variability of the factor "sex" on fetal morbidity
Measured: Day 7
Apgar score
To study the variability of the factor " Apgar score " on fetal morbidity
Measured: Day 7
twinning
To study the variability of the factors "twinning" on fetal morbidity
Measured: 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
Measured: Day 7
ethnicity
To study the variability of the factor "ethnicity" on fetal morbidity
Measured: Day 7
maternal disease and treatment
To study the variability of the factor " maternal disease and treatment on fetal morbidity
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study start12 Jan 2012
- Primary completion30 Jun 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnant Women Receive CelestenStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Yves Ville, MD, PhD, Principal investigator, Necker Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854840
- Sponsor's protocol ID
- NI10069
- Other IDs
- 2011-A01257-34
- Acronym
- b-Mhyalines
- Status last verified
- Mar 2026
- First submitted
- 2 Apr 2012
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 32394434
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Betamethasone and Severity of Hyaline Membrane Disease in the Newborn Premature
- ClinicalTrials.gov ID
- NCT01854840
- Acronym / sponsor ID
- b-Mhyalines / NI10069
- Conditions
- Pregnant Women Receive Celesten
- Keywords
- hyaline membrane disease, placenta, betamethasone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 12 Jan 2012 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 16 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients undergoing treatment with corticosteroids in the long term
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
12 secondary outcomes
Genetic polymorphisms
Time frame: Day 1
mode of delivery
Time frame: Day 7
blood sample of betamethasone
Time frame: Day 1 and day 2
Optimal dose of betamethasone
Time frame: Day 28
gestational age
Time frame: Day 7
birth weight
Time frame: Day 7
sex
Time frame: Day 7
Apgar score
Time frame: Day 7
twinning
Time frame: Day 7
time between birth and the last dose
Time frame: Day 7
ethnicity
Time frame: Day 7
maternal disease and treatment
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Results publication: PubMed 32394434Foissac 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves Ville, MD, PhD principal investigator
Necker Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnant Women Receive Celesten, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of neonates with hyaline membrane disease (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01854840, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.