Antenatal Magnesium Sulphate in High-Risk Preterm Patients

NCT07524972 | Recruiting Phase 3 DMC

• 1 other identifier: Suez Canal-MD-2025
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy; Magnesium Sulfate Overdose

Keywords

Antenatal; Magnesium Sulphate; Preterm; cerebral palsy

Outcome Measures

Primary Outcomes (1)

• Combined incidence of death or cerebral palsy

  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 Outcomes (2)

• Maternal side effects of magnesium sulphate

  From the date and time of magnesium sulphate infusion initiation until hospital discharge, assessed up to 48 hours.

• Neonatal morbidity

  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.

Study Arms (2)

Magnesium Sulphate

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Magnesium sulfate DRUG

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.

Also known as: MgSO₄

Magnesium Sulphate

Placebo DRUG

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.

Also known as: Isotonic sodium chloride 0.9%, Normal saline

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead
• Suez Canal University: collaborator

Study Sites (1)

Suez Canal University

Ismailia, Ismailia Governorate, 8366004, Egypt

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Premature Birth

Interventions

Magnesium Sulfate; Saline Solution

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

mohamed shaaban, MD

CONTACT

+2010 05153911; mshaaban@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is designed as a double-blind randomized clinical trial. Allocation will be concealed using sequentially numbered opaque sealed envelopes. Study drugs will be coded by a pharmacist, labels will be replaced with plain covers, and the code key will be kept until the end of the study. Participants, investigators, care providers administering the coded infusion, and outcome assessors will remain unaware of treatment assignment. Pediatricians and psychologists performing follow-up neurodevelopmental assessments will also be blinded to allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of obstetrics and gynecology

Model Details: Eligible women at high risk of preterm birth will be randomized in a 1:1 ratio to 2 parallel groups. One group will receive intravenous magnesium sulfate, and the other will receive a placebo using the same administration schedule. Outcomes will be compared between the 2 concurrently assigned groups.

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 13, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): May 30, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available beginning 6 months after publication of the main study results and will remain available for 5 years.
• 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.

Locations

EG (1)