Magnesium Sulphate Neuroprotective Strategies for Preterm Deliveries

NCT05674565 | Unknown Phase 2 DMC

• 1 other identifier: MGSULPH NEUROPROTECT EGYPT
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

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).

Conditions

Premature Birth; NEUROPROTECTION; MAGNESIUM SULPHATE; Cerebral Palsy; Neonatal Death

Keywords

CEREBRAL PALSY; PRETERM BIRTH; NEUROPROTECTION; NEONATAL DEATH; MAGNESIUM SULPHATE

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Postpartum hemorrhage

  Risk of primary postpartum hemorrhage

  first 24 hours after delivery

Secondary Outcomes (2)

• Late appearing neurologic insults

  at 24 months age after delivery

• Neonatal death

  28 days from birth

Study Arms (3)

Loading dose only

EXPERIMENTAL

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

Loading plus maintenance dose

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Magnesium sulfate loading with maintenance dose DRUG

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

Also known as: complete therapy

Loading plus maintenance dose

Magnesium sulfate loading dose only DRUG

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

Also known as: short therapy

Loading dose only

Eligibility Criteria

• Age: 24 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• Plurality or parity
• Reason for the risks of preterm birth
• Anticipated mode of birth
• Whether antenatal corticosteroids have been given or not

You may not qualify if:

• Women with known Hypersensitivity to magnesium
• Caution regarding dosage for patients with renal impairment
• Preterm delivery after 34 weeks

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of medicine, Zagazig University

Zagazig, Sharqia Province, 44519, Egypt

RECRUITING

Related 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.

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Premature Birth; Cerebral Palsy; Perinatal Death

Interventions

Short-Wave Therapy

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics; Radiofrequency Therapy

Study Officials

• Hytham Atia, M.D.

  Zagazig University

  STUDY CHAIR

• Amro Alnemr, M.D.

  Zagazig University

  PRINCIPAL INVESTIGATOR

• Mohamed Lashin, M.D.

  Zagazig University

  PRINCIPAL INVESTIGATOR

• Sherief M El Gebaly, M.D.

  Zagazig University

  PRINCIPAL INVESTIGATOR

• Mohamed Arafa, M.D.

  Zagazig University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hytham Atia, M.D

CONTACT

+9660538308500; hythamatia@gmail.com

Amro Alnemr, M.D.

CONTACT

+201224581528; amrabmohsen@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 19, 2022
• First Posted: January 6, 2023
• Study Start: January 20, 2023
• Primary Completion: June 30, 2024
• Study Completion: July 15, 2024
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)