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Role of Magnesium suplhate to mother in protecting brain of preterm babies

Antenatal magnesium sulphate for neuroprotection in preterm infants : An open label randomized control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/06/014386
Enrollment
30
Registered
2018-06-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Preterm infants

Interventions

Intervention1: Magnesium Sulphate plus standard of care: A bolus of 4 g(8ml) Magnesium Sulphate(50% w/v) in 12ml normal saline intravenously (IV) over 20 minutes followed by infusion of Magnesium Sulp

Sponsors

PGIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Gestational age less than or equal to 32 weeks 2. Singleton or multiple pregnancy at risk for preterm delivery within the next 24 hours 3. Active preterm labor with cervix 4â??8 cm dilated or preterm premature rupture of membranes or Indicated preterm birth within the next 24 hours

Exclusion criteria

Exclusion criteria: 1. Maternal contraindications to receiving magnesium sulfate like renal failure, cardiac arrhythmia, myasthenia gravis, hypersensitive to drug, heart block, diabetic coma, electrolyte disorder 2. Preeclampsia, eclampsia 3. Fetal distress, abruptio placenta, severe antepartum hemorrhage where urgent delivery is indicated. 4. Precipitate labor 5. Chorioamnionitis 6. Major fetal abnormalities 7. Intrauterine fetal death

Design outcomes

Primary

MeasureTime frame
Combined outcome of mortality or abnormal neurodevelopmental outcome at 6 months of corrected age as determined by developmental assessment scale for Indian infants (DASII)Timepoint: after birth to 6 months of corrected age

Secondary

MeasureTime frame
2. Neurodevelopmental outcome as determined by developmental assessment scale for Indian infants (DASII)Timepoint: 6 months;Maternal adverse events following magnesium sulphate infusionTimepoint: till maternal discharge;Neonatal mortalityTimepoint: after birth

Countries

India

Contacts

Public ContactGeeta Gathwala

Pt B D Sharma PGIMS Rohtak

geetagathwala@gmail.com9896489650

Outcome results

None listed

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