Magnesium Sulphate Neuroprotective Strategies for Preterm Deliveries

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05674565
• Other study ID #: MGSULPH NEUROPROTECT EGYPT
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 20, 2023
• Est. completion date: July 15, 2024

Study information

• Verified date: July 2023
• Source: Zagazig University
• Contact: Hytham Atia, M.D
• Phone: +9660538308500
• Email: hythamatia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 336
• Est. completion date: July 15, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 24 Weeks to 34 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• MAGNESIUM SULPHATE
• Neonatal Death
• NEUROPROTECTION
• Perinatal Death
• Premature Birth

Intervention

Drug:
• Magnesium sulfate loading with maintenance dose
4 gm MgSo4 loading over 20 minutes followed by 1 gm per hour maintenance till delivery
• Magnesium sulfate loading dose only
4 gm MgSo4 loading over 20 minutes within one hour before delivery

Locations

Country	Name	City	State
Egypt	Faculty of medicine, Zagazig University	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Shennan A, Suff N, Jacobsson B, Simpson JL, Norman J, Grobman WA, Bianchi A, Mujanja S, Valencia CM, Mol BW. FIGO good practice recommendations on magnesium sulfate administration for preterm fetal neuroprotection. Int J Gynecol Obstet. 2021;155(1):31-33. doi:10.1002/ijgo.13856.

Usman S, Foo L, Tay J, Bennett PR, Lees C. Use of magnesium sulfate in preterm deliveries for neuroprotection of the neonate. Obstet Gynaecol. 2017;19(1):21-28. doi:10.1111/tog.12328

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal Neurological insult	The incidence of neurological insults during the first year of life (including cerebral palsy, brain leukomalacia, intraventricular hemorrhage, and neonatal seizures)	at 18 months age after delivery
Primary	Maternal toxicity	Risk of maternal magnesium sulphate toxicity (affected reflexes, respiratory and cardiac), postpartum hemorrhage.	from start of therapy, till 12 hours after end of therapy
Primary	Postpartum hemorrhage	Risk of primary postpartum hemorrhage	first 24 hours after delivery
Secondary	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.	at 24 months age after delivery
Secondary	Neonatal death	Death within first 28 days after delivery	28 days from birth