NCT05674565

Magnesium Sulphate Neuroprotective Strategies for Preterm Deliveries

The Neuroprotective Impact of Magnesium Sulphate Therapy for Preterm Deliveries. Loading Dose Alone Strategy Versus Loading Plus Maintenance Dose Strategy.

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 336 (estimated)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: 24 Weeks – 34 Weeks
• Healthy volunteers: Not accepted

Summary

A Cochrane systematic review has confirmed that fetal exposure to magnesium sulphate given before preterm birth has a neuroprotective role. This review also showed a significant reduction in the rate of gross motor dysfunction in early childhood. Early Preterm birth (\< 34+0 weeks) and very low birthweight (\< 1,500 g) are the principal risk factors for cerebral palsy. Multiple pregnancy accounts for over 10% of preterm births and has a higher incidence of cerebral palsy than singleton pregnancy (twins have 7 times and triplets 47 times the risk of cerebral palsy compared with singletons).

Detailed description

Many of these patients come or get diagnosed as eminent preterm delivery very soon before the real delivery happens and are not able to complete the recommended therapy of loading and maintenance strategy for at least complete 4 hours before delivery. Till now, there is a gap and lack of knowledge regarding the value of loading dose only as sufficient and effective strategy for neuroprotection compared to full therapy, which needs more health costs, longer monitoring and carries more risk for the patients.

Conditions

• Premature Birth
• NEUROPROTECTION
• MAGNESIUM SULPHATE
• Cerebral Palsy
• Neonatal Death

Interventions

Type	Name	Description
DRUG	Magnesium sulfate loading with maintenance dose	4 gm MgSo4 loading over 20 minutes followed by 1 gm per hour maintenance till delivery
DRUG	Magnesium sulfate loading dose only	4 gm MgSo4 loading over 20 minutes within one hour before delivery

Timeline

• Start date: 2023-01-20
• Primary completion: 2024-06-30
• Completion: 2024-07-15
• First posted: 2023-01-06
• Last updated: 2023-07-14

Locations

1 site across 1 country: Egypt