Magnesium Sulphate Neuroprotective Strategies for Preterm Deliveries

Phase 2

Recruiting

• Conditions: NEUROPROTECTION; Premature Birth; MAGNESIUM SULPHATE; Cerebral Palsy; Neonatal Death
• Interventions: Drug: Magnesium sulfate loading dose only; Drug: Magnesium sulfate loading with maintenance dose

• Registration Number: NCT05674565
• Lead Sponsor: Zagazig University

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.

Study Timeline

• Study First Submitted: 2022-11-19
• Study First Submitted QC: 2022-12-31
• Study First Posted: 2023-01-06
• Study Start: 2023-01-20
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-11
• Last Update Posted: 2023-07-14
• Primary Completion: 2024-06-30
• Study Completion: 2024-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 336

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Loading dose only	Magnesium sulfate 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
Loading plus maintenance dose	Magnesium sulfate loading with 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.

Primary Outcome Measures

Name	Time	Method
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)
Postpartum hemorrhage	first 24 hours after delivery	Risk of primary postpartum hemorrhage
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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Faculty of medicine, Zagazig University; 🇪🇬 Zagazig, Sharkia, Egypt