Magnesium Sulfate for Fetal Neuroprotection

Magnesium Sulphate for Fetal Neuroprotection in Full Term Deliveries

Pregnant women diagnosed to have intrapartum fetal distress (Non reassuring or pathological changes according to NICE guidelines 2017) in any of the groups will receive the allocated treatment at least 20 minute before the procedure (emergency CS).

measures to reduce the effect of hypoxia will be applied to all participate through:

• The position of the mother will be changed to left lateral position (allow increased blood supply).
• I.V. fluid bolus (to avoid maternal dehydration).
• Oxytocin or cervical ripening agent will be discontinued.
• Fetal heart rate monitoring with cardiotocography will be attempted.
• If umbilical cord prolapse is noted, elevate the presenting fetal part until preparing for emergency operative delivery.
• After birth, Apgar score will be used to identify distress newborns that need resuscitation.

The study comprised 200 pregnant women. They were divided into two groups each are 100:

• Group A: pregnant women diagnosed to have intrapartum fetal distress who will receive MgSO4.
• Group B: pregnant women diagnosed to have intrapartum fetal distress who will receive placebo

Study Overview

• Status: Recruiting
• Conditions: Fetal Neuroprotection
• Intervention / Treatment: Drug: MgSo4; Drug: Isotonic saline

Detailed Description

Pregnant women diagnosed to have intrapartum fetal distress (Non reassuring or pathological changes according to NICE guidelines 2017) in any of the groups will receive the allocated treatment at least 20 minute before the procedure (emergency CS).

measures to reduce the effect of hypoxia will be applied to all participate through:

• The position of the mother will be changed to left lateral position (allow increased blood supply).
• I.V. fluid bolus (to avoid maternal dehydration).
• Oxytocin or cervical ripening agent will be discontinued.
• Fetal heart rate monitoring with cardiotocography will be attempted.
• If umbilical cord prolapse is noted, elevate the presenting fetal part until preparing for emergency operative delivery.
• After birth, Apgar score will be used to identify distress newborns that need resuscitation.

The study comprised 200 pregnant women. They were divided into two groups each are 100:

• Group A: pregnant women diagnosed to have intrapartum fetal distress who will receive MgSO4.
• Group B: pregnant women diagnosed to have intrapartum fetal distress who will receive placebo

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Maged; Phone Number: +201005227404; Email: ahmedmaged@cu.edu.eg
• Study Contact Backup: Name: Wesam Deeb; Email: wessamdeeb74@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 12151
    • Recruiting
    • Kasr Alainy Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pregnant women at least 37 week of gestation.
• Not more than 35 years old.
• Fetal distress (perinatal asphyxia) diagnosed by CTG changes (Non reassuring or pathological changes according to NICE guidelines 2017).
• Clinical chorioamnionitis.
• Prolonged rupture of membranes

Exclusion Criteria:

• Medical disorders such as chronic hypertension, preeclampsia, eclampsia, DM, pulmonary hypertension, hepatic coma with risk of renal failure, and any renal, cardiac or pulmonary disease.
• RH -ve.
• Consanguinity.
• Preterm labor.
• Fetal malpresentation.
• Contraindications to the use of Magnesium Sulphate.
• Any indication for magnesium Sulphate therapy (seizure prophylaxis or tocolysis).
• Myasthenia gravis.
• Congenital fetal anomalies.
• Fetal growth restriction (birth weight < 10th Percentile for gestational age).
• Advanced cervical dilation (8cm).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MgSO4 group; will receive a single bolus dose of 4g MgSO4 slowly intravenous over 15-20 minutes without maintenance dose	Drug: MgSo4; a single bolus dose of 4g MgSO4 slowly intravenous over 15-20 minutes without maintenance dose.; Other Names: magnesium sulfate
Placebo Comparator: placebo group; will receive an equal volume of isotonic 0.9% saline over 15-20 minutes	Drug: Isotonic saline; equal volume of isotonic 0.9% saline over 15-20 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apgar score	Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration between 0 and 10	1 minute after delivery

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: May 21, 2020
• First Submitted That Met QC Criteria: May 22, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 5, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Magnesium Sulfate
• Other Study ID Numbers: 60

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