NCT03210350

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
26 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

May 31, 2019

Status Verified

November 1, 2018

Enrollment Period

12 months

First QC Date

June 20, 2017

Last Update Submit

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

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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

Locations