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. |