Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2020-05-21
2021-09-30
Brief Summary
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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
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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MgSO4 group
will receive a single bolus dose of 4g MgSO4 slowly intravenous over 15-20 minutes without maintenance dose
MgSo4
a single bolus dose of 4g MgSO4 slowly intravenous over 15-20 minutes without maintenance dose.
placebo group
will receive an equal volume of isotonic 0.9% saline over 15-20 minutes
Isotonic saline
equal volume of isotonic 0.9% saline over 15-20 minutes
Interventions
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MgSo4
a single bolus dose of 4g MgSO4 slowly intravenous over 15-20 minutes without maintenance dose.
Isotonic saline
equal volume of isotonic 0.9% saline over 15-20 minutes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
40 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Ahmed M Maged, MD
professor
Locations
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Kasr Alainy medical school
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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60
Identifier Type: -
Identifier Source: org_study_id
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