Magnesium Sulfate for Fetal Neuroprotection
- Registration Number
- NCT04401852
- Lead Sponsor
- Cairo University
- Brief 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 200
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo group Isotonic saline will receive an equal volume of isotonic 0.9% saline over 15-20 minutes MgSO4 group MgSo4 will receive a single bolus dose of 4g MgSO4 slowly intravenous over 15-20 minutes without maintenance dose
- Primary Outcome Measures
Name Time Method Apgar score 1 minute after delivery Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration between 0 and 10
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kasr Alainy medical school
🇪🇬Cairo, Egypt