Clinical trial NCT05674565: Magnesium Sulphate Neuroprotective Strategies for Preterm Deliveries
Official title: The Neuroprotective Impact of Magnesium Sulphate Therapy for Preterm Deliveries. Loading Dose Alone Strategy Versus Loading Plus Maintenance Dose Strategy.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Premature Birth
NEUROPROTECTION
MAGNESIUM SULPHATE
Cerebral Palsy
Neonatal Death
Keywords: CEREBRAL PALSY
PRETERM BIRTH
NEUROPROTECTION
NEONATAL DEATH
MAGNESIUM SULPHATE
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2023-01-06
Enrollment: 336
Sex: ALL
Minimum age (years): 24
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neonatal Neurological insult
timeFrame: at 18 months age after delivery
measure: Maternal toxicity
timeFrame: from start of therapy, till 12 hours after end of therapy
measure: Postpartum hemorrhage
timeFrame: first 24 hours after delivery
Secondary outcomes:
measure: Late appearing neurologic insults
timeFrame: at 24 months age after delivery
measure: Neonatal death
timeFrame: 28 days from birth
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of medicine, Zagazig University
state: Sharkia
Study officials:
affiliation: Zagazig University
name: Hytham Atia, M.D.
role: STUDY_CHAIR
affiliation: Zagazig University
name: Amro Alnemr, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Zagazig University
name: Mohamed Lashin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Zagazig University
name: Sherief M El Gebaly, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Zagazig University
name: Mohamed Arafa, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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