An Early Phase 1 interventional study of Magnesium Sulfate and 0.9% sodium chloride solution in Preterm Birth, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2016-02-01.
Sponsored by Cairo University · Early Phase 1, Interventional, and Diagnostic
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.
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.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 60 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
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
this group will receive sodium chloride 0.9% solution for 24 hours.
Other: 0.9% sodium chloride solution
magnesium sulfate will be given for 24 hours
Also known as: MgSO4
normal saline will be given as intravenous drip over 24 hours
changes in fetal middle cerebral artery Doppler indices
Time frame: 3 months
maternal adverse effects of magnesium sulfate
Time frame: 3 months
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Cairo University