Antenatal betamethasone for women at risk for late preterm delivery

C. Gyamfi-Bannerman*, E. A. Thom, S. C. Blackwell, A. T.N. Tita, U. M. Reddy, G. R. Saade, D. J. Rouse, D. S. McKenna, E. A.S. Clark, J. M. Thorp, E. K. Chien, Alan M Peaceman, R. S. Gibbs, G. K. Swamy, M. E. Norton, B. M. Casey, S. N. Caritis, J. E. Tolosa, Y. Sorokin, J. P. Van Dorsten & 1 others L. Jain

*Corresponding author for this work

Research output: Contribution to journalArticle

183 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1311-1320
Number of pages10
JournalNew England Journal of Medicine
Volume374
Issue number14
DOIs
StatePublished - Apr 7 2016

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Betamethasone
Pregnancy
Placebos
Transient Tachypnea of the Newborn
Confidence Intervals
Oxygen
Chorioamnionitis
Bronchopulmonary Dysplasia
Extracorporeal Membrane Oxygenation
Continuous Positive Airway Pressure
Stillbirth
Respiratory Rate
Artificial Respiration
Hypoglycemia
Surface-Active Agents
Multicenter Studies
Morbidity
Injections
Incidence

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Gyamfi-Bannerman, C., Thom, E. A., Blackwell, S. C., Tita, A. T. N., Reddy, U. M., Saade, G. R., ... Jain, L. (2016). Antenatal betamethasone for women at risk for late preterm delivery. New England Journal of Medicine, 374(14), 1311-1320. https://doi.org/10.1056/NEJMoa1516783
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, Alan M ; Gibbs, R. S. ; Swamy, G. K. ; Norton, M. E. ; Casey, B. M. ; Caritis, S. N. ; Tolosa, J. E. ; Sorokin, Y. ; Van Dorsten, J. P. ; Jain, L. / Antenatal betamethasone for women at risk for late preterm delivery. In: New England Journal of Medicine. 2016 ; Vol. 374, No. 14. pp. 1311-1320.
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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.",
author = "C. Gyamfi-Bannerman and Thom, {E. A.} and Blackwell, {S. C.} and Tita, {A. T.N.} and Reddy, {U. M.} and Saade, {G. R.} and Rouse, {D. J.} and McKenna, {D. S.} and Clark, {E. A.S.} and Thorp, {J. M.} and Chien, {E. K.} and Peaceman, {Alan M} and Gibbs, {R. S.} and Swamy, {G. K.} and Norton, {M. E.} and Casey, {B. M.} and Caritis, {S. N.} and Tolosa, {J. E.} and Y. Sorokin and {Van Dorsten}, {J. P.} and L. Jain",
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Gyamfi-Bannerman, C, Thom, EA, Blackwell, SC, Tita, ATN, Reddy, UM, Saade, GR, Rouse, DJ, McKenna, DS, Clark, EAS, Thorp, JM, Chien, EK, Peaceman, AM, Gibbs, RS, Swamy, GK, Norton, ME, Casey, BM, Caritis, SN, Tolosa, JE, Sorokin, Y, Van Dorsten, JP & Jain, L 2016, 'Antenatal betamethasone for women at risk for late preterm delivery', New England Journal of Medicine, vol. 374, no. 14, pp. 1311-1320. https://doi.org/10.1056/NEJMoa1516783

Antenatal betamethasone for women at risk for late preterm delivery. / 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, Alan M; Gibbs, R. S.; Swamy, G. K.; Norton, M. E.; Casey, B. M.; Caritis, S. N.; Tolosa, J. E.; Sorokin, Y.; Van Dorsten, J. P.; Jain, L.

In: New England Journal of Medicine, Vol. 374, No. 14, 07.04.2016, p. 1311-1320.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Antenatal betamethasone for women at risk for late preterm delivery

AU - Gyamfi-Bannerman, C.

AU - Thom, E. A.

AU - Blackwell, S. C.

AU - Tita, A. T.N.

AU - Reddy, U. M.

AU - Saade, G. R.

AU - Rouse, D. J.

AU - McKenna, D. S.

AU - Clark, E. A.S.

AU - Thorp, J. M.

AU - Chien, E. K.

AU - Peaceman, Alan M

AU - Gibbs, R. S.

AU - Swamy, G. K.

AU - Norton, M. E.

AU - Casey, B. M.

AU - Caritis, S. N.

AU - Tolosa, J. E.

AU - Sorokin, Y.

AU - Van Dorsten, J. P.

AU - Jain, L.

PY - 2016/4/7

Y1 - 2016/4/7

N2 - 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.

AB - 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.

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Gyamfi-Bannerman C, Thom EA, Blackwell SC, Tita ATN, Reddy UM, Saade GR et al. Antenatal betamethasone for women at risk for late preterm delivery. New England Journal of Medicine. 2016 Apr 7;374(14):1311-1320. https://doi.org/10.1056/NEJMoa1516783