Magnesium Sulphate Neuroprotective Strategies for Preterm Deliveries

July 11, 2023 updated by: Hytham Atia, Zagazig University

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

336

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Sharkia
      • Zagazig, Sharkia, Egypt, 44519
        • Recruiting
        • Faculty of Medicine, Zagazig University
        • Contact:
        • Principal Investigator:
          • Amro El Nemr, M.D.
        • Principal Investigator:
          • Mohamed Lashin, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Loading dose only
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
4 gm MgSo4 loading over 20 minutes within one hour before delivery
Other Names:
  • short therapy
Experimental: Loading plus maintenance dose
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
4 gm MgSo4 loading over 20 minutes followed by 1 gm per hour maintenance till delivery
Other Names:
  • complete therapy
No Intervention: Control
comparable number of women who did not receive magnesium sulphate neuroprotection for any reason

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal Neurological insult
Time Frame: at 18 months age after delivery
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
Time Frame: from start of therapy, till 12 hours after end of therapy
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
Time Frame: first 24 hours after delivery
Risk of primary postpartum hemorrhage
first 24 hours after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late appearing neurologic insults
Time Frame: at 24 months age after delivery
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
Neonatal death
Time Frame: 28 days from birth
Death within first 28 days after delivery
28 days from birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Study Chair: Hytham Atia, M.D., Zagazig University
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

July 15, 2024

Study Registration Dates

First Submitted

November 19, 2022

First Submitted That Met QC Criteria

December 31, 2022

First Posted (Actual)

January 6, 2023

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MGSULPH NEUROPROTECT EGYPT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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