Magnesium Sulphate Neuroprotective Strategies for Preterm Deliveries

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Premature Birth, NEUROPROTECTION, MAGNESIUM SULPHATE, Cerebral Palsy, Neonatal Death

Intervention / Treatment
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* Drug: Magnesium sulfate loading with maintenance dose
* Drug: Magnesium sulfate loading dose only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Weeks
Maximum Age: 34 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Loading dose only<br>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 | Drug: Magnesium sulfate loading dose only<br>* 4 gm MgSo4 loading over 20 minutes within one hour before delivery<br>* Other names: short therapy;|
| Experimental: Loading plus maintenance dose<br>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. | Drug: Magnesium sulfate loading with maintenance dose<br>* 4 gm MgSo4 loading over 20 minutes followed by 1 gm per hour maintenance till delivery<br>* Other names: complete therapy;|
| No Intervention: Control<br>comparable number of women who did not receive magnesium sulphate neuroprotection for any reason | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal Neurological insult | The incidence of neurological insults during the first year of life (including cerebral palsy, brain leukomalacia, intraventricular hemorrhage, and neonatal seizures) | at 18 months age after delivery | 
| Maternal toxicity | Risk of maternal magnesium sulphate toxicity (affected reflexes, respiratory and cardiac), postpartum hemorrhage. | from start of therapy, till 12 hours after end of therapy | 
| Postpartum hemorrhage | Risk of primary postpartum hemorrhage | first 24 hours after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late appearing neurologic insults | Risk of gross motor delay, epilepsy, impaired fine motor skills, sensorineural (hearing and vision) impairment, and possibly two years of age developmental quotient. | at 24 months age after delivery | 
| Neonatal death | Death within first 28 days after delivery | 28 days from birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CEREBRAL PALSY, PRETERM BIRTH, NEUROPROTECTION, NEONATAL DEATH, MAGNESIUM SULPHATE