Effect of steroid in expecting mothers delivering prematurely on the blood glucose levels of the newborn baby-A study from a developing country
- Conditions
- Health Condition 1: P041- Newborn affected by other maternalmedication
- Registration Number
- CTRI/2021/05/033444
- Lead Sponsor
- Institute of Post Graduate Medical Education and Research Department of Neonatology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 298
1.Women with singleton pregnancy presenting between 34 weeks -36 6/7 weeks of gestation who are likely to deliver within next 7 days. Indicators of delivery within next 7 days are the presence of true labor pain, antepartum hemorrhage, preterm premature rupture of membrane, severe pre-eclampsia and evidence of fetal distress.
2.Women with singleton pregnancy admitted between 34 weeks -36 6/7 weeks of gestation for scheduled caesarian section.
1.Presence of clinical chorioamnionitis
2. Presence of multiple pregnancy
3. If the woman had already received antenatal steroid before study enrollment
4. Absence of the first trimester dating scan or unsure about the date of last menstrual period
5.Presence of major congenital anomaly, chromosomal anomaly or surgical conditions either diagnosed antenatally or detected postnatally
6.Family history or presence of congenital hyperinsulinism , metabolic disorder, or Beckwith -Wiedemann syndrome in the newborn
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Neonatal hypoglycemia which will be defined as a whole blood glucose level of 40 mg/dL2. For screening purpose initial blood glucose will be measured from capillary blood with a point of care glucometer. Any CBG value 40 mg/dL will be confirmed by whole blood glucose value.Timepoint: 1.At 2 hours of life <br/ ><br>2.At 6 hours of life <br/ ><br>3.At 12 hours of life <br/ ><br>4.At 24 hours of life <br/ ><br>5.At 48 hours of life <br/ ><br>6.At 72 hours of life
- Secondary Outcome Measures
Name Time Method 1.Symptomatic hypoglycaemia <br/ ><br>2.Duration of hypoglycemia <br/ ><br>3.Respiratory distress syndrome <br/ ><br>4.Transient tachypnea of the newborn <br/ ><br>5.Apnea <br/ ><br>6.Hemodynamically significant Patent ductus arteriosus <br/ ><br>7.Intraventricular hemorrhage <br/ ><br>8.Necrotizing enterocolitis <br/ ><br>9.Bronchopulmonary dysplasia <br/ ><br>10. requirement of respiratory support and duration <br/ ><br>11. Requirement of surfactant <br/ ><br>12.Hospital stay <br/ ><br>Timepoint: 1. At discharge from hospital