Fetal Middle Cerebral Artery Doppler in Preterm Births Receiving Magnesium Sulfate for Neuroprotection

Study Overview
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Brief Summary
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Two groups of women with preterm labor will be included. One will receive magnesium sulfate for neuroprotection and the other will receive placebo. Fetal middle cerebral artery Doppler indices will be measured before and after intake of either magnesium sulfate or placebo to find if any significant changes occur in fetal cerebral blood flow.

Detailed Description
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The study will include women with preterm labor with gestational age less than 32 weeks. women will be randomized to receive either magnesium sulfate (loading dose 6 g over 20 minutes followed by maintenance dose of 1 g/hour for 24 hours), or placebo in the form of sodium chloride solution 0.9% over 24 hours. Fetal middle cerebral artery Doppler indices [Peak systolic velocity (PSV), Pulsatility index (PI), and resistance index (RI)] will be recorded before and after treatment in both groups. Results of Doppler indices will be compared between both groups and before and after intake of magnesium sulfate to find out if middle cerebral artery Doppler of the fetus can explain the mechanism behind the use of magnesium sulfate for fetal neuroprotection in preterm births.

Official Title
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Fetal Middle Cerebral Artery Doppler in Preterm Births Receiving Magnesium Sulfate for Neuroprotection

Conditions
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Preterm Birth

Intervention / Treatment
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* Drug: Magnesium Sulfate
* Other: 0.9% sodium chloride solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant women with preterm labor gestational age less than 32 weeks singleton pregnancy Exclusion Criteria: contraindication or hypersensitivity to magnesium preeclampsia multiple pregnancy intake of magnesium sulfate in this pregnancy before

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: magnesium sulfate<br>this group will receive magnesium sulfate loading dose 6 g in 500 cc of ringer solution over 20 minutes then maintenance dose of 1 g/ hour for 24 hours. | Drug: Magnesium Sulfate<br>* magnesium sulfate will be given for 24 hours<br>* Other names: MgSO4;|
| Placebo Comparator: placebo group<br>this group will receive sodium chloride 0.9% solution for 24 hours. | Other: 0.9% sodium chloride solution<br>* normal saline will be given as intravenous drip over 24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in fetal middle cerebral artery Doppler indices |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal adverse effects of magnesium sulfate |  | 3 months |