Magnesium Sulfate for Fetal Neuroprotection

Study Overview
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Brief Summary
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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
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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

Official Title
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Magnesium Sulphate for Fetal Neuroprotection in Full Term Deliveries

Conditions
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Fetal Neuroprotection

Intervention / Treatment
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* Drug: MgSo4
* Drug: Isotonic saline


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |