Antenatal Magnesium Sulphate in High-Risk Preterm Patients

April 10, 2026 updated by: ahmed nagy shaker ramadan, Cairo University

Assessment of the Role of Antenatal Magnesium Sulphate in High-Risk Preterm Patients With Cerebral Palsy: a Randomized Clinical Trial

The goal of this clinical trial is to evaluate whether antenatal magnesium sulphate reduces the risk of cerebral palsy in infants born to women at high risk of preterm birth. It will also assess the safety of magnesium sulfate for both the mother and the neonate. The main question it aims to answer is whether magnesium sulphate given before anticipated preterm delivery decreases the incidence of cerebral palsy without causing significant maternal or neonatal adverse effects. Researchers will compare magnesium sulphate with a placebo in women at high risk of preterm birth between 32 and 35 weeks of gestation. Participants will be randomly assigned to receive either intravenous magnesium sulphate or a placebo before delivery, and maternal and neonatal outcomes will be followed after birth, including neurodevelopmental assessment of the infant.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Preterm birth is strongly associated with adverse neonatal outcomes, including cerebral palsy, which remains one of the most important long-term neurodevelopmental complications among preterm infants. Antenatal magnesium sulphate has been proposed as a fetal neuroprotective therapy because of its potential to reduce neuronal injury through anti-inflammatory, anti-excitotoxic, and membrane-stabilising effects. Although previous trials and systematic reviews support its neuroprotective role, further evaluation is needed in women at high risk of preterm delivery to assess its effectiveness and safety in routine obstetric practice.

This study is a randomised, placebo-controlled clinical trial conducted at Suez Canal University Hospital. Eligible pregnant women at high risk of preterm birth between 32 and 35 weeks of gestation, in whom delivery is planned or expected within 24 hours, will be randomised to receive either intravenous magnesium sulphate or placebo. The magnesium sulphate regimen consists of a loading dose followed by a maintenance infusion for up to 24 hours or until delivery. The placebo group will receive an isotonic sodium chloride solution administered in the same volume and schedule. Allocation concealment and blinding procedures are used so that participants and outcome assessors remain unaware of treatment assignment.

All participants will receive standard obstetric and neonatal care in addition to the assigned study treatment. Maternal monitoring during infusion will include clinical assessment and observation for adverse effects. Neonatal follow-up will include routine postnatal assessment and cranial ultrasound screening when indicated. Infants will undergo follow-up after discharge, with neurodevelopmental evaluation at corrected age to assess for cerebral palsy. The trial is designed to determine whether antenatal magnesium sulphate provides fetal neuroprotection in women at risk of preterm birth while maintaining acceptable maternal and neonatal safety.

Study Type

Interventional

Enrollment (Estimated)

138

Phase

  • 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 Locations

  • Egypt
    • Ismailia Governorate
      • Ismailia, Ismailia Governorate, Egypt, 8366004
        • Recruiting
        • Suez Canal University
        • Principal Investigator:
          • Ahmed N Afifi, MD
        • Contact:

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

  • Adult

Accepts Healthy Volunteers

No

Description

  • Inclusion Criteria:

    • Pregnant women at high risk of preterm birth between 32 and 35 weeks of gestation
    • Birth is planned or expected within 24 hours
    • Singleton pregnancy
    • No contraindication to antenatal magnesium sulphate
    • Able to provide informed consent

  • Exclusion Criteria:

    • Higher-order multiple pregnancy
    • Received antenatal magnesium sulphate during the current pregnancy for hypertension or preeclampsia
    • Magnesium sulphate is required for treatment of preeclampsia
    • Second stage of labor
    • Respiratory rate less than 16 breaths per minute
    • Absent patellar reflexes
    • Urine output less than 100 mL in the previous 4 hours
    • Renal failure
    • Hypocalcemia
    • Myasthenia gravis
    • Magnesium sulphate infusion had to be stopped because of adverse effects

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnesium Sulphate
Participants in this arm will receive intravenous magnesium sulfate for fetal neuroprotection, given as a 4 g loading dose (8 mL) over 20 minutes followed by a maintenance infusion of 1 g/hour (2 mL/hour) until delivery or for up to 24 hours.
Drug: Magnesium sulfate
Intravenous magnesium sulphate administered for fetal neuroprotection in women at high risk of preterm birth. Treatment is given as a loading dose followed by continuous maintenance infusion, with maternal monitoring during administration. The intervention is used for neuroprotection and not for tocolysis.
Other Names:
  • MgSO₄
Placebo Comparator: Placebo
Participants in this arm will receive placebo as isotonic sodium chloride 0.9%, given intravenously as 8 mL over 20 minutes followed by a maintenance infusion of 2 mL/hour until delivery or for up to 24 hours, using the same schedule as the active treatment arm.
Drug: Placebo
Intravenous placebo infusion using isotonic sodium chloride 0.9%, administered in the same volume and schedule as the active treatment to maintain blinding. Maternal monitoring during infusion is performed in the same manner as in the active treatment group.
Other Names:
  • Normal saline
  • Isotonic sodium chloride 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combined incidence of death or cerebral palsy
Time Frame: By 6 months corrected age
Composite outcome defined as stillbirth, neonatal mortality, or cerebral palsy diagnosed by corrected age follow-up assessment. Cerebral palsy will be identified by a blinded pediatric and psychological assessment using established diagnostic criteria, including motor dysfunction or tone abnormalities.
By 6 months corrected age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal side effects of magnesium sulphate
Time Frame: From the date and time of magnesium sulphate infusion initiation until hospital discharge, assessed up to 48 hours.
Incidence of maternal adverse effects related to study treatment, including flushing, hypotension, and respiratory depression.
From the date and time of magnesium sulphate infusion initiation until hospital discharge, assessed up to 48 hours.
Neonatal morbidity
Time Frame: From birth through 4 weeks after birth, cranial ultrasound was assessed within 7 days after birth and repeated at 4 weeks after birth when clinically indicated.
Incidence of neonatal morbidity including intraventricular hemorrhage, periventricular leukomalacia, and respiratory distress syndrome
From birth through 4 weeks after birth, cranial ultrasound was assessed within 7 days after birth and repeated at 4 weeks after birth when clinically indicated.

Collaborators and Investigators

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

Sponsor

Cairo University

Collaborators

Suez Canal University

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 (Estimated)

May 1, 2026

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

May 30, 2028

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Suez Canal-MD-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the reported results will be shared. This will include baseline maternal characteristics, treatment allocation, maternal safety data, delivery data, neonatal outcomes, and follow-up data used for assessment of the primary and secondary outcomes, including cerebral palsy evaluation and other recorded maternal and neonatal outcomes. Personal identifiers will be removed before sharing

IPD Sharing Time Frame

Data will be available beginning 6 months after publication of the main study results and will remain available for 5 years.

IPD Sharing Access Criteria

Access will be provided to qualified researchers for scientifically sound research proposals. Requests should include a brief proposal, analysis plan, and institutional affiliation. Data will be shared after approval by the principal investigator and local ethics requirements and after signing a data access or data use agreement. Only de-identified data will be released.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

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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