Antenatal Betamethasone for Women at Risk for Late Preterm Delivery

doi:10.1056/NEJMoa1516783

Randomized Controlled Trial

. 2016 Apr 7;374(14):1311-20.

doi: 10.1056/NEJMoa1516783. Epub 2016 Feb 4.

Antenatal Betamethasone for Women at Risk for Late Preterm Delivery

Cynthia Gyamfi-Bannerman¹, Elizabeth A Thom¹, Sean C Blackwell¹, Alan T N Tita¹, Uma M Reddy¹, George R Saade¹, Dwight J Rouse¹, David S McKenna¹, Erin A S Clark¹, John M Thorp Jr¹, Edward K Chien¹, Alan M Peaceman¹, Ronald S Gibbs¹, Geeta K Swamy¹, Mary E Norton¹, Brian M Casey¹, Steve N Caritis¹, Jorge E Tolosa¹, Yoram Sorokin¹, J Peter VanDorsten¹, Lucky Jain¹; NICHD Maternal–Fetal Medicine Units Network

Collaborators, Affiliations

Collaborators

NICHD Maternal–Fetal Medicine Units Network:
S Bousleiman, R Wapner, M DiVito, M Talucci, L Plante, C Tocci, M Hoffman, S Lynch, A Ranzini, M Lake, J Smulian, D Skupski, F Ortiz, B Sibai, M Hutchinson, P Givens, L Garcia, S Harris, J Biggio, A Todd, L Merin, G Adams, M Tew, J Grant, A Salazar, L McCoy, B Aguillon, M Wilson, J Sikes, G Hankins, G Olson, H Harirah, D Allard, L Beati, B Wallin, J Rousseau, B Hughes, F Johnson, M Prasad, J Iams, R Ozug, T Dible, K Snow, K Fennig, S Webster, M Donohue, K Hill, A Sowles, S Timothy, P Reed, M Varner, K Clark, S Timlin, R Bass, K Dorman, S Brody, J Warren, M Duchon, W Dalton, C Milluzzi, L Wolfe, K Kushner, B Mercer, G Mallett, W Grobman, L Stein, M Dinsmoor, K Paychek, K Hale, M Hoffman, J C Carey, H Galan, K Heyborne, T Metz, A Rosenberg, T Bishop, A Murtha, R Heine, C Grotegut, L Brancazio, K Kushniruk, Y El-Sayed, D Lyell, A Sit, C Willson, A Monk, E Kogut, R Knapp, L Moseley, J Price, M Santillan, J Gerald, A Sias, K Gonzales, H Simhan, H Birkland, P Cotroneo, L Pereira, C McEvoy, M Rincon, J Snyder, N Hauff, K Jablonski, V Momirova, G Heinrich, T Billingsley, T Spangler, C Spong, S Tolivaisa

Affiliation

¹ 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 Human Development, Bethesda, MD (U.M.R.); Brown University, Providence, RI (D.J.R.); Ohio State University, Columbus (D.S.M.), and the MetroHealth Medical Center, Case Western Reserve University, Cleveland (E.K.C.) - both in Ohio; the University of Utah Health Sciences Center, Salt Lake City (E.A.S.C.); the University of North Carolina at Chapel Hill, Chapel Hill (J.M.T.), and Duke University, Durham (G.K.S.) - both in North Carolina; Northwestern University, Chicago (A.M.P.); the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Stanford University, Stanford, CA (M.E.N.); University of Pittsburgh, Pittsburgh (S.N.C.); Oregon Health and Science University, Portland (J.E.T.); Wayne State University, Detroit (Y.S.); the Medical University of South Carolina, Charleston (J.P.V.); and Emory University, Atlanta (L.J.).

PMID: 26842679
PMCID: PMC4823164
DOI: 10.1056/NEJMoa1516783

Randomized Controlled Trial

Antenatal Betamethasone for Women at Risk for Late Preterm Delivery

Cynthia Gyamfi-Bannerman et al. N Engl J Med. 2016.

. 2016 Apr 7;374(14):1311-20.

doi: 10.1056/NEJMoa1516783. Epub 2016 Feb 4.

Authors

Collaborators

NICHD Maternal–Fetal Medicine Units Network:
S Bousleiman, R Wapner, M DiVito, M Talucci, L Plante, C Tocci, M Hoffman, S Lynch, A Ranzini, M Lake, J Smulian, D Skupski, F Ortiz, B Sibai, M Hutchinson, P Givens, L Garcia, S Harris, J Biggio, A Todd, L Merin, G Adams, M Tew, J Grant, A Salazar, L McCoy, B Aguillon, M Wilson, J Sikes, G Hankins, G Olson, H Harirah, D Allard, L Beati, B Wallin, J Rousseau, B Hughes, F Johnson, M Prasad, J Iams, R Ozug, T Dible, K Snow, K Fennig, S Webster, M Donohue, K Hill, A Sowles, S Timothy, P Reed, M Varner, K Clark, S Timlin, R Bass, K Dorman, S Brody, J Warren, M Duchon, W Dalton, C Milluzzi, L Wolfe, K Kushner, B Mercer, G Mallett, W Grobman, L Stein, M Dinsmoor, K Paychek, K Hale, M Hoffman, J C Carey, H Galan, K Heyborne, T Metz, A Rosenberg, T Bishop, A Murtha, R Heine, C Grotegut, L Brancazio, K Kushniruk, Y El-Sayed, D Lyell, A Sit, C Willson, A Monk, E Kogut, R Knapp, L Moseley, J Price, M Santillan, J Gerald, A Sias, K Gonzales, H Simhan, H Birkland, P Cotroneo, L Pereira, C McEvoy, M Rincon, J Snyder, N Hauff, K Jablonski, V Momirova, G Heinrich, T Billingsley, T Spangler, C Spong, S Tolivaisa

Affiliation

¹ 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 Human Development, Bethesda, MD (U.M.R.); Brown University, Providence, RI (D.J.R.); Ohio State University, Columbus (D.S.M.), and the MetroHealth Medical Center, Case Western Reserve University, Cleveland (E.K.C.) - both in Ohio; the University of Utah Health Sciences Center, Salt Lake City (E.A.S.C.); the University of North Carolina at Chapel Hill, Chapel Hill (J.M.T.), and Duke University, Durham (G.K.S.) - both in North Carolina; Northwestern University, Chicago (A.M.P.); the University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Stanford University, Stanford, CA (M.E.N.); University of Pittsburgh, Pittsburgh (S.N.C.); Oregon Health and Science University, Portland (J.E.T.); Wayne State University, Detroit (Y.S.); the Medical University of South Carolina, Charleston (J.P.V.); and Emory University, Atlanta (L.J.).

PMID: 26842679
PMCID: PMC4823164
DOI: 10.1056/NEJMoa1516783

Erratum in

Antenatal Betamethasone for Women at Risk for Late Preterm Delivery.
[No authors listed] [No authors listed] N Engl J Med. 2023 May 4;388(18):1728. doi: 10.1056/NEJMx220010. N Engl J Med. 2023. PMID: 37133608 No abstract available.

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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Figures

**Figure 1**
Screening, Enrollment, Randomization and Follow-Up of the Study Participants

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Comment in

Corticosteroids in women at risk of late preterm delivery may reduce respiratory complications in newborns.
Mayor S. Mayor S. BMJ. 2016 Feb 7;352:i747. doi: 10.1136/bmj.i747. BMJ. 2016. PMID: 26858235 No abstract available.
Antenatal Glucocorticoids for Late Preterm Birth?
Crowther CA, Harding JE. Crowther CA, et al. N Engl J Med. 2016 Apr 7;374(14):1376-7. doi: 10.1056/NEJMe1601867. N Engl J Med. 2016. PMID: 27050210 No abstract available.
Antenatal Betamethasone for Women at Risk for Late Preterm Delivery.
Gyamfi-Bannerman C, Thom EA. Gyamfi-Bannerman C, et al. N Engl J Med. 2016 Aug 4;375(5):486-7. doi: 10.1056/NEJMc1605902. N Engl J Med. 2016. PMID: 27518669 No abstract available.
Antenatal Betamethasone for Women at Risk for Late Preterm Delivery.
Stutchfield PR, Kotecha S, Doull IJ. Stutchfield PR, et al. N Engl J Med. 2016 Aug 4;375(5):485-6. doi: 10.1056/NEJMc1605902. N Engl J Med. 2016. PMID: 27518670 No abstract available.
Antenatal Betamethasone for Women at Risk for Late Preterm Delivery.
Redlich A, Böttger R, Costa SD. Redlich A, et al. N Engl J Med. 2016 Aug 4;375(5):486. doi: 10.1056/NEJMc1605902. N Engl J Med. 2016. PMID: 27518671 No abstract available.
Antenatal Betamethasone for Women at Risk for Late Preterm Delivery.
Smith GC. Smith GC. N Engl J Med. 2016 Aug 4;375(5):486. doi: 10.1056/NEJMc1605902. N Engl J Med. 2016. PMID: 27518672 No abstract available.
PURLs: Steroids during late preterm labor: Better later than never.
Lyon C, Bello JK. Lyon C, et al. J Fam Pract. 2017 Feb;66(2):104-106. J Fam Pract. 2017. PMID: 28222458 Free PMC article.
Antenatal betamethasone for women at risk for late preterm delivery reduces the rate of neonatal respiratory complications.
Canty HR, Dukhovny S, Warren JB. Canty HR, et al. Acta Paediatr. 2017 Oct;106(10):1708. doi: 10.1111/apa.13825. Epub 2017 Apr 18. Acta Paediatr. 2017. PMID: 28419555 No abstract available.
Antenatal betamethasone prevented respiratory distress syndrome in late preterm infants.
Moore H, Venugopalan V. Moore H, et al. Arch Dis Child Educ Pract Ed. 2018 Aug;103(4):218. doi: 10.1136/archdischild-2017-313632. Epub 2017 Sep 2. Arch Dis Child Educ Pract Ed. 2018. PMID: 28866616 No abstract available.
Pulmonology in Pregnancy.
Abston ED, Hon SM, Berical A. Abston ED, et al. Am J Respir Crit Care Med. 2018 Jan 1;197(1):127-129. doi: 10.1164/rccm.201707-1436RR. Am J Respir Crit Care Med. 2018. PMID: 29155600 No abstract available.

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References

1. Effect of corticosteroids for fetal maturation on perinatal outcomes. NIH consensus statement. 1994;12:1–24. - PubMed
1. 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. - PubMed
1. Crowley PA. Antenatal corticosteroid therapy: a meta-analysis of the randomized trials, 1972 to 1994. Am J Obstet Gynecol. 1995;173:322–35. - PubMed
1. Roberts D, Dalziel S. Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth. Cochrane database of systematic reviews. 2006:CD004454. - PubMed
1. Escobar GJ, Clark RH, Greene JD. Short-term outcomes of infants born at 35 and 36 weeks gestation: we need to ask more questions. Semin Perinatol. 2006;30:28–33. - PubMed

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[1] Effect of corticosteroids for fetal maturation on perinatal outcomes. NIH consensus statement. 1994;12:1–24. - PubMed

[2] Effect of corticosteroids for fetal maturation on perinatal outcomes. NIH consensus statement. 1994;12:1–24. - PubMed

[3] 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. - PubMed

[4] 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. - PubMed

[5] Crowley PA. Antenatal corticosteroid therapy: a meta-analysis of the randomized trials, 1972 to 1994. Am J Obstet Gynecol. 1995;173:322–35. - PubMed

[6] Crowley PA. Antenatal corticosteroid therapy: a meta-analysis of the randomized trials, 1972 to 1994. Am J Obstet Gynecol. 1995;173:322–35. - PubMed

[7] Roberts D, Dalziel S. Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth. Cochrane database of systematic reviews. 2006:CD004454. - PubMed

[8] Roberts D, Dalziel S. Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth. Cochrane database of systematic reviews. 2006:CD004454. - PubMed

[9] Escobar GJ, Clark RH, Greene JD. Short-term outcomes of infants born at 35 and 36 weeks gestation: we need to ask more questions. Semin Perinatol. 2006;30:28–33. - PubMed

[10] Escobar GJ, Clark RH, Greene JD. Short-term outcomes of infants born at 35 and 36 weeks gestation: we need to ask more questions. Semin Perinatol. 2006;30:28–33. - PubMed

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Antenatal Betamethasone for Women at Risk for Late Preterm Delivery

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