A new study co-authored by Alan Peaceman, MD, chief of Maternal-Fetal Medicine in the Department of Obstetrics and Gynecology, suggests giving the steroid betamethasone to women at risk for late preterm delivery significantly reduces the rate of neonatal complications.
Published in the New England Journal of Medicine, the multicenter, randomized clinical trial enrolled pregnant women with a single baby at 34 weeks to 36 weeks, 5 days of gestation, who were at a high risk for delivering during this late preterm period.
“If a baby is predicted to be born early, the mother receives steroids before the baby is born to prevent complications, but we never gave it after 34 weeks, because it was thought that the risks weren’t that great to justify giving it,” Dr. Peaceman said. “Then data came out that there were some adverse outcomes after 34 weeks and the effective period could be extended to 37 weeks. Our data showed a significant reduction in a number of neonatal complications and is very likely to change practice in this country over the next few months.”
The 17 clinical centers that participated in the study are part of the Maternal-Fetal Medicine Units Network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
From 2010 to 2015, the 2,831 participants enrolled were randomly assigned to a course of two injections containing either betamethasone or a placebo administered 24 hours apart. Betamethasone reduces adverse neonatal outcomes including respiratory complications and death.
The rate of the primary outcome – the need for respiratory support – was lower in the betamethasone group than placebo. Additionally, there were significantly lower rates of severe respiratory complications including transient tachypnea – abnormally rapid breathing – and bronchopulmonary dysplasia with the need for resuscitation at birth. Infants born in the betamethasone group were also less likely to spend three or more days in the intensive care unit or nursery and had a shorter time until the first feeding.
While the administration of betamethasone did increase neonatal hypoglycemia – low blood sugar – there were no reported adverse events related to it. There were also no significant differences in maternal outcomes between the betamethasone and placebo groups.
“We are already talking about how to implement this at Northwestern Medicine,” Dr. Peaceman said. “Changing this practice has the potential for significantly reducing the number of babies going to neonatal intensive care unit, which is not just a big cost saving, but also important to parents.”
The research was supported by National Heart, Lung, and Blood Institute grants HL098554 and HL098354, by Eunice Kennedy Shriver National Institute of Child Health and Human Development grants HD21410, HD27915, HD27917, HD27869, HD34116, HD34208, HD40485, HD40500, HD40512, HD40544, HD40545, HD40560, HD53097, HD53118, HD68268, HD68258, HD68282 and HD36801 and by National Center for Advancing Translational Sciences, National Institutes of Health grant UL1 TR000040.