Back to resultsFetal Middle Cerebral Artery Doppler in Preterm Births Receiving Magnesium Sulfate for Neuroprotection
Primary Purpose
Preterm Birth
Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Magnesium Sulfate
0.9% sodium chloride solution
Sponsored by
About this trial
This is an interventional diagnostic trial for Preterm Birth
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
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
magnesium sulfate
placebo group
Arm 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.
this group will receive sodium chloride 0.9% solution for 24 hours.
Outcomes
Primary Outcome Measures
changes in fetal middle cerebral artery Doppler indices
Secondary Outcome Measures
maternal adverse effects of magnesium sulfate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02506894
Brief Title
Fetal Middle Cerebral Artery Doppler in Preterm Births Receiving Magnesium Sulfate for Neuroprotection
Official Title
Fetal Middle Cerebral Artery Doppler in Preterm Births Receiving Magnesium Sulfate for Neuroprotection
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
magnesium sulfate
Arm Type
Active Comparator
Arm 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.
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
this group will receive sodium chloride 0.9% solution for 24 hours.
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Other Intervention Name(s)
MgSO4
Intervention Description
magnesium sulfate will be given for 24 hours
Intervention Type
Other
Intervention Name(s)
0.9% sodium chloride solution
Intervention Description
normal saline will be given as intravenous drip over 24 hours
Primary Outcome Measure Information:
Title
changes in fetal middle cerebral artery Doppler indices
Time Frame
3 months
Secondary Outcome Measure Information:
Title
maternal adverse effects of magnesium sulfate
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghada Abdel Fattah Abdel Moety, lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
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Fetal Middle Cerebral Artery Doppler in Preterm Births Receiving Magnesium Sulfate for Neuroprotection
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