Full versus half dose of antenatal betamethasone to prevent severe neonatal respiratory distress syndrome associated with preterm birth: study protocol for a randomised, multicenter, double blind, placebo-controlled, non-inferiority trial (BETADOSE)

Schmitz, Thomas; Alberti, Corinne; Ursino, Moreno; Baud, Olivier; Aupiais, Camille; BETADOSE study group and the GROG (Groupe de Recherche en Gynécologie Obstétrique)

doi:10.1186/s12884-019-2206-x

Scientific article

English

Full versus half dose of antenatal betamethasone to prevent severe neonatal respiratory distress syndrome associated with preterm birth: study protocol for a randomised, multicenter, double blind, placebo-controlled, non-inferiority trial (BETADOSE)

ContributorsSchmitz, Thomas; Alberti, Corinne; Ursino, Moreno; Baud, Olivier; Aupiais, Camille; BETADOSE study group and the GROG (Groupe de Recherche en Gynécologie Obstétrique)

Published inBMC Pregnancy and Childbirth, vol. 19, no. 1, 67

Publication date2019

Abstract

Although antenatal betamethasone is recommended worldwide for women at risk of preterm delivery, concerns persist regarding the long-term effects associated with this treatment. Indeed, adverse events, mainly dose-related, have been reported. The current recommended dose of antenatal betamethasone directly derives from sheep experiments performed in the late 60's and has not been challenged in 45 years. Therefore, randomized trials evaluating novel dose regimens are urgently needed.

Keywords

Betamethasone/administration & dosage
Clinical Protocols
Double-Blind Method
Female
France
Glucocorticoids/administration & dosage
Humans
Infant, Newborn
Pregnancy
Premature Birth/drug therapy
Prenatal Care/methods
Randomized Controlled Trials as Topic
Research Design
Respiratory Distress Syndrome, Newborn/drug therapy/prevention & control

Affiliation entities

Faculté de médecine / Section de médecine clinique / Département de pédiatrie, gynécologie et obstétrique

Research groups

Prévention des complications néonatales d'origine périnatale (990)

Citation (ISO format)

SCHMITZ, Thomas et al. Full versus half dose of antenatal betamethasone to prevent severe neonatal respiratory distress syndrome associated with preterm birth: study protocol for a randomised, multicenter, double blind, placebo-controlled, non-inferiority trial (BETADOSE). In: BMC Pregnancy and Childbirth, 2019, vol. 19, n° 1, p. 67. doi: 10.1186/s12884-019-2206-x