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Effect of steroid in expecting mothers delivering prematurely on the blood glucose levels of the newborn baby-A study from a developing country

Effect of Antenatal Dexamethasone in Late Preterm Period on Neonatal Hypoglycemia - A Prospective Cohort Study from a Developing Country

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033444
Enrollment
276
Registered
2021-05-07
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P041- Newborn affected by other maternalmedication

Interventions

Intervention1: Antenatal Dexamethasone: Women who receive at least one dose of injection dexamethasone in the late preterm period (34 weeks to 36 6/7 weeks gestation) between 7 days before delivery an

Sponsors

Institute of Post Graduate Medical Education and Research Department of Neonatology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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 2.At 6 hours of life 3.At 12 hours of life 4.At 24 hours of life 5.At 48 hours of life 6.At 72 hours of life

Secondary

MeasureTime frame
1.Symptomatic hypoglycaemia 2.Duration of hypoglycemia 3.Respiratory distress syndrome 4.Transient tachypnea of the newborn 5.Apnea 6.Hemodynamically significant Patent ductus arteriosus 7.Intraventricular hemorrhage 8.Necrotizing enterocolitis 9.Bronchopulmonary dysplasia 10. requirement of respiratory support and duration 11. Requirement of surfactant 12.Hospital stay Timepoint: 1. At discharge from hospital

Countries

India

Contacts

Public ContactSomnath Pal

Institute of Post Graduate Medical Education and Research

somnathpal1983@gmail.com9903457386

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026