| Title: |
Neonatal Outcomes for Women at Risk of Preterm Delivery Given Half Dose Versus Full Dose of Antenatal Betamethasone: A Randomized, Multicentre, Double-blind, Placebo-Controlled, Non-inferiority Trial |
| Authors: |
Schmitz, Thomas; Doret-Dion, Muriel; Sentilhes, Loic; Parant, Olivier; Claris, Olivier; Renesme, Laurent; Abbal, Julie; Girault, Aude; Torchin, Héloïse; Houllier, Marie; Le Saché, Nolwenn; Vivanti, Alexandre J.; De Luca, Daniele; Winer, Norbert; Flamant, Cyril; Thuillier, Claire; Boileau, Pascal; Blanc, Julie; Brevaut, Véronique; Bouet, Pierre-Emmanuel; Gascoin, Géraldine; Beucher, Gaël; Datin-Dorriere, Valérie; Bounan, Stéphane; Bolot, Pascal; Poncelet, Christophe; Alberti, Corinne; Ursino, Moreno; Aupiais, Camille; Baud, Olivier |
| Source: |
Obstetrical & Gynecological Survey ; volume 78, issue 2, page 81-83 ; ISSN 1533-9866 0029-7828 |
| Publisher Information: |
Ovid Technologies (Wolters Kluwer Health) |
| Publication Year: |
2023 |
| Description: |
Antenatal corticosteroid administration to women at risk of preterm delivery is recommended worldwide because of their effectiveness in preventing respiratory distress syndrome, as well as in reducing the rate of necrotizing enterocolitis, intraventricular hemorrhage, and neonatal death in preterm infants. However, the current usual dosage regimen of 2 injections of 12 mg of betamethasone (BMZ) 24 hours apart originated from preclinical experiments in the 1960s and has not been investigated in randomized clinical trials. These authors therefore designed a randomized trial for investigating whether a half dose of BMZ would be as effective as the standard full-dose regimen. The primary outcome was the need for exogenous surfactant within the first 48 hours of life. Secondary outcomes included the incidence and severity of respiratory disease, such as respiratory distress syndrome. This randomized, multicenter, double-blind placebo-controlled, noninferiority study was conducted in 37 perinatal centers in France. Pregnant women 18 years or older with singleton pregnancies at risk of delivery preterm (and already treated with dose 1 of antenatal BMZ before 32 weeks' gestation) were eligible to participate. Exclusion criteria included multiple pregnancy, having previously received full-dose antenatal corticosteroids, 4 cm or greater cervical dilation, cervical length of 20 mm or greater, fetal major malformations or chromosomal aberrations, or being unable to communicate fluently in French. Upon hospital admission after the first BMZ injection, women were provided information about the trial, and those who agreed were randomly assigned in a 1:1 ratio to receive either a saline placebo or the second intramuscular BMZ dose. A total of 3196 women participated, with 1597 in the half-dose group and 1599 in the full-dose group. In all, 30 fetuses were stillborn, 16 neonates were lost to follow-up, and 9 neonates died before evaluation, leaving 1567 neonates in the half-dose group and 1574 neonates in the full-dose ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1097/ogx.0000000000001127 |
| DOI: |
10.1097/OGX.0000000000001127 |
| Availability: |
https://doi.org/10.1097/ogx.0000000000001127; https://journals.lww.com/10.1097/OGX.0000000000001127 |
| Accession Number: |
edsbas.352681BB |
| Database: |
BASE |