Magnesium Sulfate for Fetal Neuroprotection

Cairo University (CU)

Status: Unknown

Conditions: Fetal Neuroprotection

Treatments: Drug: Isotonic saline; Drug: MgSo4

Study type: Interventional

Funder types: Other

Identifiers

NCT04401852

60

Details and patient eligibility

About

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

Full 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

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

MgSO4 group

Active Comparator group

Description:

will receive a single bolus dose of 4g MgSO4 slowly intravenous over 15-20 minutes without maintenance dose

Treatment:

Drug: MgSo4

placebo group

Placebo Comparator group

Description:

will receive an equal volume of isotonic 0.9% saline over 15-20 minutes

Treatment:

Drug: Isotonic saline