Fetal Neuroprotection
Conditions
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
Interventions
DRUGMgSo4
a single bolus dose of 4g MgSO4 slowly intravenous over 15-20 minutes without maintenance dose.
DRUGIsotonic saline
equal volume of isotonic 0.9% saline over 15-20 minutes
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apgar score | 1 minute after delivery | Apgar stands for Appearance, Pulse, Grimace, Activity, and Respiration between 0 and 10 |
Countries
Egypt
Contacts
Primary ContactAhmed maged
Backup ContactWesam Deeb
Outcome results
None listed