- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02506894
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
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-
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Cairo, Egypt
- Cairo University
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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.
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magnesium sulfate will be given for 24 hours
Other Names:
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Placebo Comparator: placebo group
this group will receive sodium chloride 0.9% solution for 24 hours.
|
normal saline will be given as intravenous drip over 24 hours
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
changes in fetal middle cerebral artery Doppler indices
Time Frame: 3 months
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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
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
- Pregnancy Complications
- Obstetric Labor Complications
- Obstetric Labor, Premature
- Premature Birth
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Magnesium Sulfate
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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