The Neuroprotective Impact of Magnesium Sulphate Therapy for Preterm Deliveries. Loading Dose Alone Strategy Versus Loading Plus Maintenance Dose Strategy.
Overview
- Phase
- Phase 2
- Intervention
- Magnesium sulfate loading dose only
- Conditions
- Premature Birth
- Sponsor
- Zagazig University
- Enrollment
- 336
- Locations
- 1
- Primary Endpoint
- Postpartum hemorrhage
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Hytham Atia
Associate professor
Zagazig University
Eligibility Criteria
Inclusion Criteria
- •Women at risk of preterm birth who are between 24+0 and 33+6 weeks of gestation.
- •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
Arms & Interventions
Loading dose only
Those receiving only the loading dose of magnesium sulphate 4 gm infusion over 20 minutes therapy within one hour before delivery without the maintenance dose
Intervention: Magnesium sulfate loading dose only
Loading plus maintenance dose
Receiving magnesium sulphate loading 4 gm infusion over 20 minutes, followed by maintenance therapy 1gm per hour infusion until delivery or completion of 24 hours, the sooner.
Intervention: Magnesium sulfate loading with maintenance dose
Outcomes
Primary Outcomes
Postpartum hemorrhage
Time Frame: first 24 hours after delivery
Risk of primary postpartum hemorrhage
Neonatal Neurological insult
Time Frame: at 18 months age after delivery
The incidence of neurological insults during the first year of life (including cerebral palsy, brain leukomalacia, intraventricular hemorrhage, and neonatal seizures)
Maternal toxicity
Time Frame: from start of therapy, till 12 hours after end of therapy
Risk of maternal magnesium sulphate toxicity (affected reflexes, respiratory and cardiac), postpartum hemorrhage.
Secondary Outcomes
- Late appearing neurologic insults(at 24 months age after delivery)
- Neonatal death(28 days from birth)