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Effect of Magnesium Sulphate on the Intracranial Pressure of Preeclamptic Patients

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Corniche Hospital
Sponsor:
Information provided by (Responsible Party):
Corniche Hospital
ClinicalTrials.gov Identifier:
NCT03210350
First received: June 20, 2017
Last updated: July 5, 2017
Last verified: July 2017
  Purpose

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.


Condition Intervention
Preeclampsia Severe Diagnostic Test: Optic nerve sheath diameter

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Magnesium Sulphate on the Intracranial Pressure of Preeclamptic Patients Using Ultrasound Measured Optic Nerve Sheath Diameter: a Pilot Study

Resource links provided by NLM:


Further study details as provided by Corniche Hospital:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 30
Actual Study Start Date: May 1, 2017
Estimated Study Completion Date: December 31, 2017
Estimated Primary Completion Date: October 31, 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Diagnostic Test: Optic nerve sheath diameter
    Optic nerve sheath diameter measurement using ultrasound
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
obstetric patients admitted to the HDU at Corniche Hospital for treatment of severe preeclampsia
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03210350

Contacts
Contact: Tarek Ansari, FFARCSI 00971561173994 tansari@seha.ae

Locations
United Arab Emirates
Corniche Hospital Recruiting
Abu Dhabi, United Arab Emirates, 3788
Contact: Tarek Ansari, FFARCSI    0097126965580    tansari@cornichehospital.ae   
Principal Investigator: Waleed Riad, MD         
Sponsors and Collaborators
Corniche Hospital
  More Information

Responsible Party: Corniche Hospital
ClinicalTrials.gov Identifier: NCT03210350     History of Changes
Other Study ID Numbers: CH29011702
Study First Received: June 20, 2017
Last Updated: July 5, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on September 19, 2017