Magnesium Sulfate for Fetal Neuroprotection

Fetal Neuroprotection Clinical Trial

Official title:

Magnesium Sulphate for Fetal Neuroprotection in Full Term Deliveries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04401852
• Other study ID #: 60
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2020
• Est. completion date: September 2021

Study information

• Verified date: February 2021
• Source: Cairo University
• Contact: Ahmed maged
• Phone: +201005227404
• Email: ahmedmaged[@]cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fetal Neuroprotection

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apgar score	Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration between 0 and 10	1 minute after delivery