Sadiq 2019.
Methods | Design: RCT Setting: Kahuta Research Laboratories (KRL), Hospital, Islamabad, Pakistan |
Participants | Inclusion criteria: pregnant women with singleton alive fetus between gestational age of 37 + 6 to 38 + 6 weeks, admitted for elective LSCS under spinal anaesthesia, gestational age confirmed by the date of last menstrual period and in cases of unsure of dates, by the first trimester dating scan, patients with uncomplicated gestational diabetes mellitus, pregnancy induced hypertension, anaemia and asthma Exclusion criteria: women with type 1 or 2 DM, chronic hypertension, preeclampsia, pre‐labour rupture of membranes, multiple pregnancies, infections including tuberculosis, congenital anomalous fetus, intrauterine growth restriction (IUGR) fetuses and emergency LSCS or operated under general anaesthesia Number randomised: 320 (A 158, B 162) Number analysed: 304 (A 152, B 152) |
Interventions | Intervention (n = 158): one course of dexamethasone within 7 days of LSCS. Two doses of 12 mg, each given intramuscularly to the pregnant woman, 12 hours apart Control (n = 162): no treatment |
Outcomes |
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Notes | Dates of study: September 2017 to September 2019 Funding sources: "Grant support and financial disclosure ‐ NIL" Declarations of interest: "Authors declared no conflict of interest" We contacted the trial authors in March 2021 to ask for more information the prospective trial registration status. The trial authors replied "a clinical protocol was designed before conducting the study that was presented to the institutional review committee. But the clinical trial was not registered except with the local hospital body and after reviewing they gave us the ethical permission and approval for conducting study." Not included in 2021 update because of lack of response from trial authors regarding our trustworthiness criteria (trial published since 2010 without prospective registration) |
BPD: bronchopulmonary dysplasia CPAP: continuous positive airway pressure CS: caesarean section DM: diabetes mellitis ECMO: extracorporeal membrane oxygenation El‐LSCS: lower (uterine) segment caesarean section IM: intramuscular IUGR: intrauterine growth restriction LMP: last menstrual period NICU: neonatal intensive care unit PROM: premature rupture of membranes RDS: respiratory distress syndrome TTN: tachypnoea of the newborn