Antenatal corticosteroids: a reappraisal of the drug formulation and dose
Open accessAbstract
We review the history of antenatal corticosteroid therapy (ACS) and present recent experimental data to demonstrate that this, one of the pillars of perinatal care, has been inadequately evaluated to minimize fetal exposure to these powerful medications. There have been concerns since 1972 that fetal exposures to ACS convey risk. However, this developmental modulator, with its multiple widespread biologic effects, has not been evaluated for drug choice, dose, or duration of treatment, despite over 30 randomized trials. The treatment used in the United States is two intramuscular doses of a mixture of 6 mg betamethasone phosphate (Beta P) and 6 mg betamethasone acetate (Beta Ac). To optimize outcomes with ACS, the goal should be to minimize fetal drug exposure. We have determined that the minimum exposure needed for fetal lung maturation in sheep, monkeys, and humans (based on published cord blood corticosteroid concentrations) is about 1 ng/ml for a 48-h continuous exposure, far lower than the concentration reached by the current dosing. Because the slowly released Beta Ac results in prolonged fetal exposure, a drug containing Beta Ac is not ideal for ACS use. Impact: Using sheep and monkey models, we have defined the minimum corticosteroid exposure for a fetal lung maturation. These results should generate new clinical trials of antenatal corticosteroids (ACS) at much lower fetal exposures to ACS, possibly given orally, with fewer risks for the fetus.
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Typically, antenatal corticosteroids are administered as two intramuscular injections of 12 mg betamethasone given 24 h apart or alternatively, four doses of 6 mg dexamethasone administered every 12 h to accelerate foetal lung maturation in anticipation of preterm delivery.
“Typically, ACS are administered as two intramuscular injections of 12 mg betamethasone given 24 h apart or alternatively, four doses of 6 mg dexamethasone administered every 12 h to accelerate foetal lung maturation in anticipation of preterm delivery. 40 , 41 , 42”
From A systematic review of glucocorticoid use in type 1 diabetes: Glycaemic effects and clinical management strategies (2026) · cites this paper as [41]
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Self-citation
- Authors
- Jobe, A. H., Kemp, M., Schmidt, A., Takahashi, T., Newnham, J., & Milad, M.
- Affiliations
- Cincinnati Children's Hospital Medical Center (US)
- Murdoch University (AU)
- University of Miami (US)
- The University of Western Australia (AU)
- Corresponding author
- Jobe, Alan H.
- Venue
- Pediatric Research
- Published
- 2020-11-11
- Volume
- 89
- Issue
- 2
- Pages
- 318-325
- ISSN
- 0031-3998 (ISSN-L)
- 1530-0447
- PMC
- PMC7892336
- OpenAlex
- W3105796402
- Cited by
- 67
- References
- 46
- Citations by year
- 2026: 7 · 2025: 14 · 2024: 11 · 2023: 9 · 2022: 20 · 2021: 5 · 2020: 1
- FWCI
- 1.23
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Pediatric Research (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Murdoch University Research Portal (submittedVersion)
- UWA Profiles and Research Repository (UWA) (submittedVersion, cc-by)
- Funders
- Bill and Melinda Gates Foundation (OPP1132910, OPP1189571)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Neonatal Respiratory Health Research
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Infant Development and Preterm Care
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Keywords
- antenatal corticosteroids, betamethasone phosphate, betamethasone acetate, prenatal drug exposure, fetal lung maturation, sheep model, monkey model, perinatal care, oral corticosteroids
- MeSH terms
- Adrenal Cortex Hormones, Animals, Drug Compounding, Female, Fetal Organ Maturity, Gestational Age, Humans, Lung, Models, Biological, Pregnancy, Prenatal Care, Risk Factors, Risk Assessment, Premature Birth, Drug Dosage Calculations
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