Magnesium Sulphate Neuroprotective Strategies for Preterm Deliveries

Zagazig University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Neonatal Death; MAGNESIUM SULPHATE; Cerebral Palsy; NEUROPROTECTION; Premature Birth

Treatments: Drug: Magnesium sulfate loading dose only; Drug: Magnesium sulfate loading with maintenance dose

Study type: Interventional

Funder types: Other

Identifiers

NCT05674565

MGSULPH NEUROPROTECT EGYPT

Details and patient eligibility

About

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).

Full 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.

Enrollment: 336 estimated patients

Sex: All

Ages: 24 to 34 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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336 participants in 3 patient groups

Loading dose only

Experimental group

Description:

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

Treatment:

Drug: Magnesium sulfate loading dose only

Loading plus maintenance dose

Experimental group

Description:

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.

Treatment:

Drug: Magnesium sulfate loading with maintenance dose

Control

No Intervention group

Description:

comparable number of women who did not receive magnesium sulphate neuroprotection for any reason