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

Cairo University (CU)

Status and phase: Completed; Early Phase 1

Conditions: Preterm Birth

Treatments: Drug: Magnesium Sulfate; Other: 0.9% sodium chloride solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02506894

Mgso4 for neuroprotection

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

magnesium sulfate

Active Comparator group

Description:

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.

Treatment:

Drug: Magnesium Sulfate

placebo group

Placebo Comparator group

Description:

this group will receive sodium chloride 0.9% solution for 24 hours.

Treatment:

Other: 0.9% sodium chloride solution