None listed
Conditions
Interventions
Intervention1: Dexamethasone sodium phosphate: 6mg IM injection, 2 doses given 12 hours apart, so that second dose is recieved 24 hours before cesarean section
Control Intervention1: Betamethasone sod
Sponsors
KMCT MEDICAL COLLEGE
Eligibility
Inclusion criteria
Inclusion criteria: Mothers with age between 18 years and 45 years are selected and those satisfying the inclusion criteria are enrolled Inclusion criteria 1 Early term babies (37+0 to 38+6 weeks) 2 Appropriate for gestational age (AGA) babies (It refers to a baby who is born with a weight between 10th and 90th percentile on the intergrowth 21 chart for gestational age and sex) 3 No antenatal risk factors for respiratory morbidity.
Exclusion criteria
Exclusion criteria: Exclusion criteria 1 All preterm babies ( 2 All term babies (=39 weeks) 3 All babies who have already received a course of antenatal steroids 4 All women who don’t have their gestational age confirmed via a first trimester’s dating scan 5 Multiple gestations 6 Risk factors like Preeclampsia Gestational diabetes mellitus (GDM) or pre-existing diabetes mellitus. Maternal chorioamnionitis Chronic hypertension, chronic renal disease, liver disease. Prenatal ultrasonographic findings, such as oligohydramnios and structural lung disorders Suspected intrauterine infections and fetus with major congenital anomalies or intrauterine growth restrictions Meconium stained amniotic fluid (Grade I meconium stained liquor is translucent, light yellow green in colour, grade II MSL is opalescent with deep green and light yellow in colour, Grade III is opaque and deep green in colour) Women who had hypersensitivities to dexamethasone/betamethasone or if the women came in labour prior to their scheduled elective CS date. Perinatal asphyxia 7 General anesthesia and intraoperative maternal hypoxia 8 SGA and LGA babies Small for gestational age (SGA) refers to a baby who is born with a weight below the 10th percentile on the intergrowth 21 chart for gestational age and sex. Large for gestational age (LGA) refers to a baby who is born with a weight above the 90th percentile on the intergrowth 21 chart for gestational age and sex. 9 Mothers who have not given consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any form of respiratory distress assessed in the form of APGAR score 7, Downes score 2 or more Timepoint: Apgar scores at 1 and 5 min of life calculated. oxygen saturation monitored at 5 and 10 min and general physical examination done. Downes score will be calculated. Repeated assessment will be done at 2, 4,6, 12, 24 hours of life. Neonates are kept under observation for a total of 24 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are severity of respiratory distress, hypoglycemia and level of care in response. Timepoint: Neonates will be assessed at 0, 2, 4, 6, 12, 24, 48 hours of life. | — |
Countries
India
Contacts
Public ContactSoumya Jose
KMCT Medical college
Outcome results
None listed