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IRCT20120918010876N4 IRCT 2018-01-11 Shahid Beheshti University of Medical Sciences Effect of steroid on neonatal respiratory morbidity in elective cesarean section in 37 weeks or later Assessment of effect of antenatal betamethasone administration on neonatal respiratory morbidity in early term (37 to 38 weeks and 6 days) elective cesarean section 2017-07-25 anticipated 220 Complete https://irct.ir/trial/11295 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization with random number table. 2 Respiratory distress syndrome of newborn. Intervention 1: Intervention group: intramuscular injection of 12 mg betamethasone in two doses between 24 hours, 48 hours before cesarean section. Intervention 2: Control group: No Treatment. No - There is not a plan to make this available Justification or reason for not sharing IPD is No need for publication of data file
public Dr. Masoome Mirzamoradi
Mahdieh Hospital, Shoosh Sq.
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 6263 drmoradi000@yahoo.com Shahid Beheshti University of Medical Sciences- Mahdieh Hospital scientific Dr. Masoome Mirzamoradi
Mahdieh Hospital, Shoosh Sq.
Tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 6263 drmoradi000@yahoo.com Shahid Beheshti University of Medical Sciences- Mahdieh Hospital Iran (Islamic Republic of) referring women for early or 37 to 38 weeks and 6 days elective cesarean section singleton pregnancy no limit no limit Female multiple pregnancies fetus with major congenital anomalies fetus with other medical or midwifery conditions that give birth earlier receive dexamethasone or betamethasone during pregnancy maternal severe hypertension maternal history of peptic ulcer evidences of intrauterine infection P22.0 Respiratory distress syndrome of newborn Treatment - Drugs Other Intervention group: intramuscular injection of 12 mg betamethasone in two doses between 24 hours, 48 hours before cesarean section Control group: No Treatment Neonatal respiratory outcomes (need for CPAP or nasal cannula with high-current continuous, need for continuous high-pressure oxygen with FiO2 more than 30%, need for mechanical ventilation, need for ECMO or resuscitation at birth, respiratory distress syndrome, neonatal tachypnea, apnea, bronchopulmonary dysplasia, pneumonia, use of surfactant). Timepoint: After cesarean until patient discharge. Method of measurement: Clinical symptoms & signs. NICU admission. Timepoint: After cesarean until patient discharge. Method of measurement: Clinical symptoms & signs. Hospitalization duraion. Timepoint: Patient discharge. Method of measurement: Patient discharge in day and hour. Shahid Beheshti University of Medical Sciences Approved 2017-07-25 Ethic's committee of Shahid Beheshti University of Medical Sciences Velenjak St., Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)