Clinical trial

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

Name
MGSULPH NEUROPROTECT EGYPT
Description
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).
Trial arms
Trial start
2023-01-20
Estimated PCD
2024-06-30
Trial end
2024-07-15
Status
Recruiting
Phase
Early phase I
Treatment
Magnesium sulfate loading with maintenance dose
4 gm MgSo4 loading over 20 minutes followed by 1 gm per hour maintenance till delivery
Arms:
Loading plus maintenance dose
Other names:
complete therapy
Magnesium sulfate loading dose only
4 gm MgSo4 loading over 20 minutes within one hour before delivery
Arms:
Loading dose only
Other names:
short therapy
Size
336
Primary endpoint
Neonatal Neurological insult
at 18 months age after delivery
Maternal toxicity
from start of therapy, till 12 hours after end of therapy
Postpartum hemorrhage
first 24 hours after delivery
Eligibility criteria
Inclusion Criteria: 1. Women at risk of preterm birth who are between 24+0 and 33+6 weeks of gestation. 2. When early preterm birth is planned or expected within 24 h, regardless of: * Plurality or parity * Reason for the risks of preterm birth * Anticipated mode of birth * Whether antenatal corticosteroids have been given or not Exclusion Criteria: * Women with known Hypersensitivity to magnesium * Caution regarding dosage for patients with renal impairment * Preterm delivery after 34 weeks
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 336, 'type': 'ESTIMATED'}}
Updated at
2023-07-14

1 organization

1 product

5 indications

Organization
Zagazig University
Indication
Preterm Birth
Indication
NEUROPROTECTION
Indication
Cerebral Palsy
Indication
Neonatal Death