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.
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).
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of medicine, Zagazig University | Zagazig | Sharkia |
Lead Sponsor | Collaborator |
---|---|
Zagazig University |
Egypt,
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
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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