Magnesium Sulphate Neuroprotective Strategies for Preterm Deliveries

Zagazig University336 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

336

Conditions

Premature Birth NEUROPROTECTION

Eligibility

Sex: ALLMin age: 24 WeeksMax age: 34 Weeks

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Neonatal Neurological insult

The incidence of neurological insults during the first year of life (including cerebral palsy, brain leukomalacia, intraventricular hemorrhage, and neonatal seizures)

Time frame: at 18 months age after delivery

Maternal toxicity

Risk of maternal magnesium sulphate toxicity (affected reflexes, respiratory and cardiac), postpartum hemorrhage.

Time frame: from start of therapy, till 12 hours after end of therapy

Postpartum hemorrhage

Risk of primary postpartum hemorrhage

Time frame: first 24 hours after delivery

Secondary Outcomes

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.

Time frame: at 24 months age after delivery

Neonatal death

Death within first 28 days after delivery

Time frame: 28 days from birth