Cynthia Gyamfi-Bannerman1, Kathleen A Jablonski2, Sean C Blackwell3, Alan T N Tita4, Uma M Reddy5, Lucky Jain6, George R Saade7, Dwight J Rouse8, Erin A S Clark9, John M Thorp10, Edward K Chien11, Alan M Peaceman12, Ronald S Gibbs13, Geeta K Swamy14, Mary E Norton15, Brian M Casey16, Steve N Caritis17, Jorge E Tolosa18, Yoram Sorokin19, J Peter VanDorsten20. 1. Department of Obstetrics and Gynecology, Columbia University, New York City, New York. 2. Department of Epidemiology, George Washington University Biostatistics Center, Washington, District of Columbia. 3. Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Texas Health Science Center, Children's Memorial Hermann Hospital, Houston, Texas. 4. Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama. 5. Department of Obstetrics, Gynecology, and Reproductive Sciences, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland. 6. Department of Pediatrics, Emory University, Atlanta, Georgia. 7. Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas. 8. Department of Obstetrics and Gynecology, Brown University, Providence, Rhode Island. 9. Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah. 10. Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina. 11. Department of Obstetrics and Gynecology Specialists, MetroHealth Medical Center, Case Western Reserve University, Cleveland, Ohio. 12. Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois. 13. Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado. 14. Department of Obstetrics and Gynecology, Duke University, Durham, North Carolina. 15. Department of Obstetrics, Gynecology, and Reproductive Sciences, Stanford University, Stanford, California. 16. Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas. 17. Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania. 18. Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, Oregon. 19. Department of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan. 20. Department of Obstetrics and Gynecology, Medical University of South Carolina, Charleston, South Carolina.
Abstract
OBJECTIVE: In the antenatal late preterm steroids (ALPS) trial betamethasone significantly decreased short-term neonatal respiratory morbidity but increased the risk of neonatal hypoglycemia, diagnosed only categorically (<40 mg/dL). We sought to better characterize the nature, duration, and treatment for hypoglycemia. STUDY DESIGN: Secondary analysis of infants from ALPS, a multicenter trial randomizing women at risk for late preterm delivery to betamethasone or placebo. This study was a reabstraction of all available charts from the parent trial, all of which were requested. Unreviewed charts included those lost to follow-up or from sites not participating in the reabstraction. Duration of hypoglycemia (<40 mg/dL), lowest value and treatment, if any, were assessed by group. Measures of association and regression models were used where appropriate. RESULTS:Of 2,831 randomized, 2,609 (92.2%) were included. There were 387 (29.3%) and 223 (17.3%) with hypoglycemia in the betamethasone and placebo groups, respectively (relative risk [RR]: 1.69, 95% confidence interval [CI]: 1.46-1.96). Hypoglycemia generally occurred in the first 24 hours in both groups: 374/385 (97.1%) in the betamethasone group and 214/222 (96.4%) in the placebo group (p = 0.63). Of 387 neonates with hypoglycemia in thebetamethasone group, 132 (34.1%) received treatment, while 73/223 (32.7%) received treatment in placebo group (p = 0.73). The lowest recorded blood sugar was similar between groups. Most hypoglycemia resolved by 24 hours in both (93.0 vs. 89.3% in the betamethasone and placebo groups, respectively, p = 0.18). Among infants with hypoglycemia in the first 24 hours, the time to resolution was shorter in the betamethasone group (2.80 [interquartile range: 2.03-7.03) vs. 3.74 (interquartile range: 2.15-15.08) hours; p = 0.002]. Persistence for >72 hours was rare and similar in both groups, nine (2.4%, betamethasone) and four (1.9%, placebo, p = 0.18). CONCLUSION: In this cohort, hypoglycemia was transient and most received no treatment, with a quicker resolution in the betamethasone group. Prolonged hypoglycemia was uncommon irrespective of steroid exposure. KEY POINTS: · Hypoglycemia was transient and approximately two-thirds received no treatment.. · Neonates in the ALPS trial who received betamethasone had a shorter time to resolution than those with hypoglycemia in the placebo group.. · Prolonged hypoglycemia occurred in approximately 2 out of 100 late preterm newborns, irrespective of antenatal steroid exposure.. Thieme. All rights reserved.
RCT Entities:
OBJECTIVE: In the antenatal late preterm steroids (ALPS) trial betamethasone significantly decreased short-term neonatal respiratory morbidity but increased the risk of neonatal hypoglycemia, diagnosed only categorically (<40 mg/dL). We sought to better characterize the nature, duration, and treatment for hypoglycemia. STUDY DESIGN: Secondary analysis of infants from ALPS, a multicenter trial randomizing women at risk for late preterm delivery to betamethasone or placebo. This study was a reabstraction of all available charts from the parent trial, all of which were requested. Unreviewed charts included those lost to follow-up or from sites not participating in the reabstraction. Duration of hypoglycemia (<40 mg/dL), lowest value and treatment, if any, were assessed by group. Measures of association and regression models were used where appropriate. RESULTS: Of 2,831 randomized, 2,609 (92.2%) were included. There were 387 (29.3%) and 223 (17.3%) with hypoglycemia in the betamethasone and placebo groups, respectively (relative risk [RR]: 1.69, 95% confidence interval [CI]: 1.46-1.96). Hypoglycemia generally occurred in the first 24 hours in both groups: 374/385 (97.1%) in the betamethasone group and 214/222 (96.4%) in the placebo group (p = 0.63). Of 387 neonates with hypoglycemia in the betamethasone group, 132 (34.1%) received treatment, while 73/223 (32.7%) received treatment in placebo group (p = 0.73). The lowest recorded blood sugar was similar between groups. Most hypoglycemia resolved by 24 hours in both (93.0 vs. 89.3% in the betamethasone and placebo groups, respectively, p = 0.18). Among infants with hypoglycemia in the first 24 hours, the time to resolution was shorter in the betamethasone group (2.80 [interquartile range: 2.03-7.03) vs. 3.74 (interquartile range: 2.15-15.08) hours; p = 0.002]. Persistence for >72 hours was rare and similar in both groups, nine (2.4%, betamethasone) and four (1.9%, placebo, p = 0.18). CONCLUSION: In this cohort, hypoglycemia was transient and most received no treatment, with a quicker resolution in the betamethasone group. Prolonged hypoglycemia was uncommon irrespective of steroid exposure. KEY POINTS: · Hypoglycemia was transient and approximately two-thirds received no treatment.. · Neonates in the ALPS trial who received betamethasone had a shorter time to resolution than those with hypoglycemia in the placebo group.. · Prolonged hypoglycemia occurred in approximately 2 out of 100 late preterm newborns, irrespective of antenatal steroid exposure.. Thieme. All rights reserved.
Authors: Ashley N Battarbee; Yuanfan Ye; Jeff M Szychowski; Brian M Casey; Alan T Tita; Kim A Boggess Journal: Am J Obstet Gynecol MFM Date: 2022-03-26
Authors: Ashley N Battarbee; Grecio J Sandoval; Cynthia Gyamfi-Bannerman; Sean C Blackwell; Alan T N Tita; Uma M Reddy; Lucky Jain Journal: Am J Obstet Gynecol Date: 2022-03-29 Impact factor: 10.693
Authors: Heather M Weydig; Charles R Rosenfeld; Myra H Wyckoff; Mambarambath A Jaleel; Patti J Burchfield; Anita Thomas; Mackenzie S Frost; Luc P Brion Journal: J Perinatol Date: 2021-11-20 Impact factor: 3.225