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Effect of Magnesium Sulphate on the Intracranial Pressure of Preeclamptic Patients

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ClinicalTrials.gov Identifier: NCT03210350
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Corniche Hospital

Tracking Information
First Submitted Date June 20, 2017
First Posted Date July 6, 2017
Last Update Posted Date May 31, 2019
Actual Study Start Date August 1, 2017
Actual Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 5, 2017)
Change in Optic nerve sheath diameter from baseline after magnesium Sulfate administration [ Time Frame: 1,6 and 24 hours ]
Change in Optic nerve sheath diameter from baseline at 1, 6 and 24 hours after completion of Magnesium sulfate loading dose
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03210350 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Magnesium Sulphate on the Intracranial Pressure of Preeclamptic Patients
Official Title Effect of Magnesium Sulphate on the Intracranial Pressure of Preeclamptic Patients Using Ultrasound Measured Optic Nerve Sheath Diameter: a Pilot Study
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.

Detailed Description

30 obstetric patients admitted to the HDU in Corniche Hospital for treatment of severe preeclampsia. Patients with the following criteria will be excluded from the current work: Patients undergone cranial or eye surgeries, Patients with known intracranial pathology, Patients suffering from glaucoma or any other eye pathology that prevent clear identification of the optic nerve, and Patients on drugs that may affect the cerebrospinal fluid [based on operator decision].

In this prospective pilot study, patients who will fulfill the inclusion criteria will be recruited at the time of admission in HDU by the investigators. The ONDS will be measured before the commencement of Magnesium sulphate infusion, 1hr after finishing the loading dose, 6 and 24 hrs after infusion started. Patients will be in supine position with the head of the bed less than 20 degrees. High frequency (7.5 MHz) linear probe will be used; it will be placed gently over both closed eye after liberal application of sterile gel, the patient will be instructed to look forward to align the optic nerve directly opposite to the probe. The ONSD will be measured 3mm behind the optic disc in both the sagittal and transverse planes and an average will be calculated and recorded. In the absence of complete visualization of the optic disc, the largest viewed diameter will be taken as the maximal ONSD. Hemodynamic variables & oxygen saturation will be recorded at the same times.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population obstetric patients admitted to the HDU at Corniche Hospital for treatment of severe preeclampsia
Condition Preeclampsia Severe
Intervention Diagnostic Test: Optic nerve sheath diameter
Optic nerve sheath diameter measurement using ultrasound
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 5, 2017)
30
Original Estimated Enrollment Same as current
Actual Study Completion Date September 30, 2018
Actual Primary Completion Date July 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • obstetric patients admitted to the HDU at Corniche Hospital for treatment of severe preeclampsia

Exclusion Criteria:

  • (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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Arab Emirates
Removed Location Countries  
 
Administrative Information
NCT Number NCT03210350
Other Study ID Numbers CH29011702
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Corniche Hospital
Study Sponsor Corniche Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Corniche Hospital
Verification Date November 2018