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Magnesium Sulphate Neuroprotective Strategies for Preterm Deliveries

NCT05674565 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2023-07-14

No results posted yet for this study

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).

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Zagazig University

    lead OTHER_GOV

Principal Investigators

  • Hytham Atia, M.D. · Zagazig University

  • Amro Alnemr, M.D. · Zagazig University

  • Mohamed Lashin, M.D. · Zagazig University

  • Sherief M El Gebaly, M.D. · Zagazig University

  • Mohamed Arafa, M.D. · Zagazig University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
24 Weeks
Max Age
34 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-20
Primary Completion
2024-06-30
Completion
2024-07-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05674565 on ClinicalTrials.gov