Magnesium Sulphate Neuroprotective Strategies for Preterm Deliveries

Sponsor

Zagazig University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05674565

Collaborator

(none)

336

Enrollment

Location

Arms

17.8

Anticipated Duration (Months)

18.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Premature Birth NEUROPROTECTION MAGNESIUM SULPHATE Cerebral Palsy Neonatal Death	Drug: Magnesium sulfate loading with maintenance dose Drug: Magnesium sulfate loading dose only	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

336 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jan 20, 2023

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jul 15, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 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

Drug: Magnesium sulfate loading dose only

4 gm MgSo4 loading over 20 minutes within one hour before delivery

Other Names:

short therapy

Experimental: Loading plus 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.

Drug: Magnesium sulfate loading with maintenance dose

4 gm MgSo4 loading over 20 minutes followed by 1 gm per hour maintenance till delivery

Other Names:

complete therapy

No Intervention: Control

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

24 Weeks to 34 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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: