Effect of Magnesium Sulphate on the Intracranial Pressure of Preeclamptic Patients
1 other identifier
observational
30
1 country
1
Brief Summary
It had been shown that high percentage of severe preeclampsia patients got a high cerebral perfusion pressure (CPP) due to abnormal autoregulation of cerebral blood vessels with associated endothelial dysfunction and disrupted blood brain barrier. Moreover, patients with high CPP is more likely to present with headache compared to other patients with normal CPP.In this particular scenario, use of magnesium sulphate is associated with marked reduction of CPP and. hence prevention of cerebral damage.This hypothesis was confirmed by new magnetic resonance techniques that demonstrated brain edema in eclampsia/ severe preeclampsia patient mostly due to vasogenic edema and less commonly attributed to cytotoxic edema. Changes in the optic nerve sheath diameter (ONSD) mirrors the changes in the Intracranial pressure(ICP), subsequently when the intracranial pressure increases the optic nerve sheath diameter (ONDS) also increases. The aim of this study is to determine the effect Magnesium sulphate infusion on intracranial pressure, in patients presented with severe preeclampsia by measuring changes in the ONSD using ultrasound examination.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2017
CompletedFirst Posted
Study publicly available on registry
July 6, 2017
CompletedStudy Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedMay 31, 2019
November 1, 2018
12 months
June 20, 2017
May 30, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Optic nerve sheath diameter from baseline after magnesium Sulfate administration
Change in Optic nerve sheath diameter from baseline at 1, 6 and 24 hours after completion of Magnesium sulfate loading dose
1,6 and 24 hours
Interventions
Optic nerve sheath diameter measurement using ultrasound
Eligibility Criteria
obstetric patients admitted to the HDU at Corniche Hospital for treatment of severe preeclampsia
You may qualify if:
- obstetric patients admitted to the HDU at Corniche Hospital for treatment of severe preeclampsia
You may not qualify if:
- (1) Patients undergone cranial or eye surgeries, (2) Patients with known intracranial pathology, (3) Patients suffering from glaucoma or any other eye pathology that prevent clear identification of the optic nerve, (4) Patients on drugs that may affect the cerebrospinal fluid
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Corniche Hospital
Abu Dhabi, 3788, United Arab Emirates
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2017
First Posted
July 6, 2017
Study Start
August 1, 2017
Primary Completion
July 30, 2018
Study Completion
September 30, 2018
Last Updated
May 31, 2019
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share