NCT04401852

Magnesium Sulfate for Fetal Neuroprotection

Magnesium Sulphate for Fetal Neuroprotection in Full Term Deliveries

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Fetal Neuroprotection

Interventions

Type	Name	Description
DRUG	MgSo4	a single bolus dose of 4g MgSO4 slowly intravenous over 15-20 minutes without maintenance dose.
DRUG	Isotonic saline	equal volume of isotonic 0.9% saline over 15-20 minutes

Timeline

• Start date: 2020-05-21
• Primary completion: 2021-08-01
• Completion: 2021-09-01
• First posted: 2020-05-26
• Last updated: 2021-02-09

Locations

1 site across 1 country: Egypt