Nada 2016.
Methods | Parallel randomised control trial |
Participants | Location: 1 hospital in Egypt Timeframe: November 2011 to December 2014 Eligibility criteria: women with a singleton pregnancy (as calculated from the first day of their last menstrual period) between 38 and 38 + 6 weeks' of pregnancy, aged between 20 and 40 years of age undergoing an elective caesarean section Exclusion criteria: women with multiple gestations or any medical problems that could affect fetal well‐being, or a fetus with a major congenital anomaly, intrauterine growth restriction, oligohydramnios or hydramnios. Women who developed spontaneous labour or had uterine contractions or tenderness were excluded. |
Interventions | Intervention: 4 doses of 8 mg of dexamethasone administered intramuscularly 12 hours apart, 48 hours prior to elective caesarean section (n = 645) Placebo: in the placebo group: women received IM saline prior to elective caesarean section (n = 645) |
Outcomes | Primary outcome: rates of NICU admissions with respiratory distress. Secondary outcomes
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Notes | Consent: verbal informed consent Funding source of study: not reported Declarations of interest: "None declared." We contacted the trial authors in January 2021 to ask for more information about their trial registration and randomisation processes. They replied that they did not register the study prospectively. Not included in 2021 update because of lack of response from trial authors regarding our trustworthiness criteria (trial published since 2010 without prospective registration) |