Cerebral Palsy, MAGNESIUM SULPHATE, Neonatal Death, NEUROPROTECTION, Premature Birth
Conditions
Keywords
CEREBRAL PALSY, PRETERM BIRTH, NEUROPROTECTION, NEONATAL DEATH, MAGNESIUM SULPHATE
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.
Interventions
DRUGMagnesium sulfate loading with maintenance dose
4 gm MgSo4 loading over 20 minutes followed by 1 gm per hour maintenance till delivery
DRUGMagnesium sulfate loading dose only
4 gm MgSo4 loading over 20 minutes within one hour before delivery
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
24 Weeks to 34 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal Neurological insult | 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 | from start of therapy, till 12 hours after end of therapy | Risk of maternal magnesium sulphate toxicity (affected reflexes, respiratory and cardiac), postpartum hemorrhage. |
| Postpartum hemorrhage | first 24 hours after delivery | Risk of primary postpartum hemorrhage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late appearing neurologic insults | at 24 months age after delivery | Risk of gross motor delay, epilepsy, impaired fine motor skills, sensorineural (hearing and vision) impairment, and possibly two years of age developmental quotient. |
| Neonatal death | 28 days from birth | Death within first 28 days after delivery |
Countries
Egypt
Contacts
Primary ContactHytham Atia, M.D
Backup ContactAmro Alnemr, M.D.
Outcome results
None listed