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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05674565
Other study ID # MGSULPH NEUROPROTECT EGYPT
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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