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. 2020 Dec 25;2020(12):CD004454. doi: 10.1002/14651858.CD004454.pub4

Mirzamoradi 2019.

Methods Two‐arm, parallel RCT
Setting: Shahid Beheshti University of Medical Sciences, Iran
Participants Inclusion criteria: Women with a single pregnancy at 34–36 weeks and 6 days of gestation, with a high probability of late preterm delivery
Exclusion criteria: those with dilatation of 4 cm or more, known congenital malformations, antenatal administration of glucocorticoids before the 34th week, fetal death, major fetal anomalies or non survivable fetus, administration of systemic corticosteroid due to other indications, gestational diabetes, prepregnancy diabetes mellitus, maternal contraindication for betamethasone, chorioamnionitis, unwillingness to participate in the study or/and participation in other intervention study
Number randomised: 240 (120 per group)
Number analysed: 240 women
Interventions Experimental: 12 mg of betamethasone in two doses with an interval of 24 hours
Control: no treatment
Outcomes Primary outcome: composite endpoint describing the need for respiratory support by 72 hours of age consisting of one or more of the following continuous positive airway pressure (CPAP) or high flow nasal cannula (HFNC) for at least two consecutive hours, respiratory distress syndrome or need for mechanical ventilation
Birthweight
First minute Agpar score
Fifth minute Agpar score
Need for resuscitation
Need for oxygen for more than one hour
Need for CPAP or continuous high‐flow nasal canula oxygen therapy
Need for continuous high oxygen with FiO2 more than 30%
Mechanical ventilation
Extracorporeal membrane oxygenation
RDS
Transient tachypnoea of the newborn
Apnoea
Bronchopulmonary dysplasia
Pneumonia
Need for surfactant
Umbilical cord blood pH
Admission to NICU
Duration of NICU admission
Duration of hospitalisation in neonatal ward after NICU
Notes Study dates: January 2017 to July 2017
Declarations of interest: quote: "No potential conflict of interest was reported by the authors"
Funding sources: not reported
Not included in 2020 update: contacted authors in September and October 2020 to query prospective trial registration; awaiting reply.