- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03891498
The Effect of Loading Dose of Magnesium Sulfate on Uterine, Umbilical, and Fetal Middle Cerebral Arteries Doppler, Biophysical Profile, CTG, Maternal Vital Signs in Women With Severe Preeclampsia
March 25, 2019 updated by: Ahmed M Maged, MD, Cairo University
100 women with severe preeclanpsia received Magnesium sulfate 6 grams intravenous over 20 minutes as a loading dose.
Resistance index [RI], pulsatility index [PI] and systolic/diastolic [S/D] ratio of the umbilical artery, uterine aryery and fetal middle cerebral artery before and repeated 20 minutes after intravenous administration of 6 grams of magnesium sulphate (loading dose) over 20 minutes .
fetal breathing movements and fetal gross movements are counted within 20 minutes, before and after intravenous administration of 6 grams of magnesium sulphate (loading dose) over 20 minutes
Study Overview
Detailed Description
100 women with severe preeclanpsia received Magnesium sulfate 6 grams intravenous over 20 minutes as a loading dose.
Resistance index [RI], pulsatility index [PI] and systolic/diastolic [S/D] ratio of the umbilical artery, uterine aryery and fetal middle cerebral artery before and repeated 20 minutes after intravenous administration of 6 grams of magnesium sulphate (loading dose) over 20 minutes .
fetal breathing movements and fetal gross movements are counted within 20 minutes, before and after intravenous administration of 6 grams of magnesium sulphate (loading dose) over 20 minutes
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ahmed Maged, MD
- Phone Number: +201005227404
- Email: prof.ahmedmaged@gmail.com
Study Contact Backup
- Name: Mohamed Elmahy, MD
- Phone Number: 01111831716
- Email: Mohamed.elmahy@kasralainy.edu.eg
Study Locations
-
-
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Cairo, Egypt, 12151
- Kasr Alainy medical school
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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:
- Singleton pregnancy.
- Primigravida or Multigravida.
- Pregnant females ≥ 37 weeks of gestation.
Diagnosed as severe preeclampsia by the following criteria:
- Sustained systolic blood pressure of ≥160 mmHg or a sustained diastolic blood pressure of ≥ 110 mmHg.
- Proteinuria measured as +1 or more by dipstick or 24 hours urine collection with proteinuria ≥ 0.3 grams.
- Oliguria or creatinine > 1.1 mg%.
- Laboratory findings characteristic of HELLP syndrome.
- Symptoms suggestive of severe preeclampsia ; severe headache, blurring of vision, epigastric pain.
Exclusion Criteria:
- Multifetal pregnancy.
- History of epilepsy.
- Patients with diabetes.
- Patients with renal disease.
- Fetuses with congenital anomalies.
- Patients receiving anticoagulants e.g. heparin (unfractionated or low molecular weight).
- Patients with severe IUGR.
- Patients with accidental hemorrhage.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MgSO4
The magnesium sulfate will be given according to the regimen of 6 grams intravenous over 20 minutes as a loading dose.
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The magnesium sulfate will be given according to the regimen of 6 grams intravenous over 20 minutes as a loading dose.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in uterine artery resistance index
Time Frame: 15 minutes after the loading dose of MgSO4
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Doppler assessment of uterine artey RI
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15 minutes after the loading dose of MgSO4
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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 (Anticipated)
March 1, 2019
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
March 24, 2019
First Submitted That Met QC Criteria
March 25, 2019
First Posted (Actual)
March 27, 2019
Study Record Updates
Last Update Posted (Actual)
March 27, 2019
Last Update Submitted That Met QC Criteria
March 25, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 53
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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