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

January 29, 2016 updated by: Ghada Abdel Fattah, Cairo University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Magnesium Sulfate
magnesium sulfate will be given for 24 hours
Other Names:
  • MgSO4
Placebo Comparator: placebo group
this group will receive sodium chloride 0.9% solution for 24 hours.
Other: 0.9% sodium chloride solution
normal saline will be given as intravenous drip over 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
changes in fetal middle cerebral artery Doppler indices
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
maternal adverse effects of magnesium sulfate
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

July 21, 2015

First Submitted That Met QC Criteria

July 22, 2015

First Posted (Estimate)

July 23, 2015

Study Record Updates

Last Update Posted (Estimate)

February 1, 2016

Last Update Submitted That Met QC Criteria

January 29, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mgso4 for neuroprotection

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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