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Cited by 819Neonatal Respiratory Health ResearchInfant Development and Preterm CarePreterm Birth and Chorioamnionitis

Antenatal Betamethasone for Women at Risk for Late Preterm Delivery

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Gyamfi-Bannerman, Cynthia, Thom, Elizabeth A., Blackwell, Sean C., Tita, Alan T.N., Reddy, Uma M., Saade, George R., Rouse, Dwight J., McKenna, David S. +13 more·2016·New England Journal of Medicine
DOI 10.1056/nejmoa1516783PMC PMC4823164
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Abstract

BACKGROUND: Infants who are born at 34 to 36 weeks of gestation (late preterm) are at greater risk for adverse respiratory and other outcomes than those born at 37 weeks of gestation or later. It is not known whether betamethasone administered to women at risk for late preterm delivery decreases the risks of neonatal morbidities. METHODS: We conducted a multicenter, randomized trial involving women with a singleton pregnancy at 34 weeks 0 days to 36 weeks 5 days of gestation who were at high risk for delivery during the late preterm period (up to 36 weeks 6 days). The participants were assigned to receive two injections of betamethasone or matching placebo 24 hours apart. The primary outcome was a neonatal composite of treatment in the first 72 hours (the use of continuous positive airway pressure or high-flow nasal cannula for at least 2 hours, supplemental oxygen with a fraction of inspired oxygen of at least 0.30 for at least 4 hours, extracorporeal membrane oxygenation, or mechanical ventilation) or stillbirth or neonatal death within 72 hours after delivery. RESULTS: The primary outcome occurred in 165 of 1427 infants (11.6%) in the betamethasone group and 202 of 1400 (14.4%) in the placebo group (relative risk in the betamethasone group, 0.80; 95% confidence interval [CI], 0.66 to 0.97; P=0.02). Severe respiratory complications, transient tachypnea of the newborn, surfactant use, and bronchopulmonary dysplasia also occurred significantly less frequently in the betamethasone group. There were no significant between-group differences in the incidence of chorioamnionitis or neonatal sepsis. Neonatal hypoglycemia was more common in the betamethasone group than in the placebo group (24.0% vs. 15.0%; relative risk, 1.60; 95% CI, 1.37 to 1.87; P<0.001). CONCLUSIONS: Administration of betamethasone to women at risk for late preterm delivery significantly reduced the rate of neonatal respiratory complications. (Funded by the National Heart, Lung, and Blood Institute and the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT01222247.).

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  • The 2016 RCT found that administration of betamethasone to women with a singleton pregnancy at risk for late preterm delivery (34+0 to 36+5 weeks of gestation) significantly reduces the rate of neonatal respiratory complications.

    “The 2016 RCT has found that the administration of betamethasone to women with a singleton pregnancy at risk for late preterm delivery (34 +0 to 36 +5 weeks of gestation) significantly reduces the rate of neonatal respiratory complications.67”

    From Placenta Praevia and Placenta Accreta: Diagnosis and Management: Green‐top Guideline No. 27a (2019) · cites this paper as [67]

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  1. [2]Effect of corticosteroids for fetal maturation on perinatal outcomes. NIH Consensus Development Panel on the Effect of Corticosteroids for Fetal Maturation on Perinatal Outcomes. Jama 1995 273 413 8 7823388

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Authors
Gyamfi-Bannerman, C., Thom, E. A., Blackwell, S. C., Tita, A. T. N., Reddy, U. M., Saade, G. R., Rouse, D. J., McKenna, D. S., Clark, E. A. S., Thorp, J. M., Chien, E. K., Peaceman, A. M., Gibbs, R. S., Swamy, G. K., Norton, M. E., Casey, B. M., Caritis, S. N., Tolosa, J. E., Sorokin, Y., VanDorsten, J. P., & Jain, L.
Affiliations
  • From Columbia University, New York (C.G.-B.); the George Washington University Biostatistics Center, Washington, DC (E.A.T.); the University of Texas Health Science Center at Children’s Memorial Hermann Hospital, Houston (S.C.B.), the University of Texas Medical Branch, Galveston (G.R.S.), and the University of Texas Southwestern Medical Center, Dallas (B.M.C.) — all in Texas; the University of Alabama at Birmingham, Birmingham (A.T.N.T.); the Eunice Kennedy Shriver National Institute of Child Health and...
  • Memorial Hermann (US)
  • Northwestern University (US)
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2016-04-07
Volume
374
Issue
14
Pages
1311-1320
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa1516783
PMC
PMC4823164
OpenAlex
W2321364247
Cited by
814
References
82
Citations by year
2026: 59 · 2025: 69 · 2024: 67 · 2023: 69 · 2022: 98 · 2021: 92 · 2020: 81 · 2019: 90 · 2018: 69 · 2017: 68 · 2016: 48 · 2015: 1
FWCI
81.34
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • National Institutes of Health (5ul1tr001067-05, UL1TR000040)
  • National Heart, Lung, and Blood Institute (R01HL098554, U01HL098554, R01HL098354, HL098554, HL098354, U01HL098354)
  • National Center for Advancing Translational Sciences (UL1-TR001067)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (HD68282, HD40512, HD53118, U01HD036801, HD27917, U10HD040544, U10HD034208, HD-27915, U10HD040512, HD34116, HD68268, UG1HD034116, HD40545, (HD40500, UG1HD053097, U10HD027915, HD68258, U10HD040545, U10HD040560, HD 40544, U10HD068268, HD40560, HD53097, U10HD027917, U10HD036801, U10HD021410, HD 34208, HD 36801, U10HD053097, U10HD034116, HD27869, UG1HD068282, [HD21410, UG1HD068258, U10HD040500, U10HD040485, U10HD053118, U10HD068282, U10HD027869, U10HD034136, UG1HD068268, U10HD068258, UG1HD034208, U24HD036801, UG1HD040500, UG1HD040512, UG1HD027869, UG1HD040544, UG1HD040485, UG1HD027915, UG1HD040560, UG1HD040545, HD 40485)
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 › Epidemiology › Preterm Birth and Chorioamnionitis
Keywords
betamethasone, antenatal corticosteroids, late preterm birth, neonatal respiratory distress, bronchopulmonary dysplasia, transient tachypnea of the newborn, neonatal hypoglycemia, neonatal sepsis, chorioamnionitis, neonatal mortality, surfactants
MeSH terms
Adult, Betamethasone, Bronchopulmonary Dysplasia, Female, Premature Rupture of Fetal Membranes, Gestational Age, Glucocorticoids, Humans, Hypoglycemia, Infant, Newborn, Infant, Premature, Infant, Premature, Diseases, Injections, Intramuscular, Obstetric Labor, Premature, Oxygen Inhalation Therapy, Pregnancy, Pregnancy Trimester, Third, Pulmonary Surfactants, Respiration, Artificial, Respiratory Tract Diseases

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