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

NCT ID: NCT02506894

Last Updated: 2016-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2015-11-30

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.

Conditions

Preterm Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Magnesium Sulfate

Intervention Type: DRUG

magnesium sulfate will be given for 24 hours

placebo group

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

Group Type: PLACEBO_COMPARATOR

0.9% sodium chloride solution

Intervention Type: OTHER

normal saline will be given as intravenous drip over 24 hours

Interventions

Magnesium Sulfate

magnesium sulfate will be given for 24 hours

Intervention Type: DRUG

0.9% sodium chloride solution

normal saline will be given as intravenous drip over 24 hours

Intervention Type: OTHER

Other Intervention Names

MgSO4

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ghada Abdel Fattah

assistant professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ghada Abdel Fattah Abdel Moety, lecturer

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Cairo University

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

Mgso4 for neuroprotection

Identifier Type: -

Identifier Source: org_study_id