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

Early Phase 1

Completed

• Conditions: Preterm Birth
• Interventions: Drug: Magnesium Sulfate; Other: 0.9% sodium chloride solution

• Registration Number: NCT02506894
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-21
• Study First Submitted QC: 2015-07-22
• Study First Posted: 2015-07-23
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-29
• Last Update Posted: 2016-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
magnesium sulfate	Magnesium Sulfate	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.
placebo group	0.9% sodium chloride solution	this group will receive sodium chloride 0.9% solution for 24 hours.

Primary Outcome Measures

Name	Time	Method
changes in fetal middle cerebral artery Doppler indices	3 months

Secondary Outcome Measures

Name	Time	Method
maternal adverse effects of magnesium sulfate	3 months

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt