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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2016/01/006576 |
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Date of registration:
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29-01-2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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MEASUREMENT OF DIAMETER OF NERVE TO THE EYE (OPTIC NERVE SHEATH DIAMETER) IN PREGNANT PATIENTS WITH SEVERE PRE-ECLAMPSIA
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Scientific title:
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SONOGRAPHIC OPTIC NERVE SHEATH DIAMETER MEASUREMENT IN MAGNESIUM SULPHATE TREATED SEVERELY PRE-ECLAMPTIC PARTURIENTS:
A PROSPECTIVE, OBSERVATIONAL STUDY
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Date of first enrolment:
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15-02-2016 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=13877 |
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Study type:
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Observational |
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Study design:
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Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Dr Nidhi Bhatia
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Address:
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Department of Anesthesia and Intensive Care PGIMER Secto 12 Chandigarh
160012
Chandigarh, CHANDIGARH
India |
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Telephone:
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Email:
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nidhi.bhatia75@gmail.com |
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Affiliation:
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PGIMER Sector 12 Chandigarh |
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Name:
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Dr Nidhi Bhatia
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Address:
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Department of Anesthesia and Intensive Care PGIMER Secto 12 Chandigarh
160012
Chandigarh, CHANDIGARH
India |
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Telephone:
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Email:
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nidhi.bhatia75@gmail.com |
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Affiliation:
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PGIMER Sector 12 Chandigarh |
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Key inclusion & exclusion criteria
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Inclusion criteria: parturients with singleton pregnancy at >= 28weeks of gestation, admitted with diagnosis of severe pre-eclampsia and scheduled to receive Magnesium Sulphate therapy, before delivery, will be included in the study.
Exclusion criteria: We will exclude the following patients from the study :
a. Presence of ocular wound
b. Prior ocular surgery
c. Patient refusal
d. Chronic hypertension
e. Hyperthyroidism
f. Severe pre-eclamptics already on MgSO4 therapy
g. Presence of pre-existing chronic lung and/or cardiac diseases
h. Presence of pre-existing chronic renal and/or hepatic diseases
i. Presence of any chronic diseases of central nervous system.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- parturients with singleton pregnancy at â?¥ 28weeks of gestation, admitted with diagnosis of severe pre-eclampsia and scheduled to receive Magnesium Sulphate therapy, before delivery
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Primary Outcome(s)
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To observe the changes in ultrasonographically measured ONSD following MgSO4 treatment in severely pre-eclamptic parturients at pre-defined intervalsTimepoint: Prior to start of MgSO4 therapy and at 4hr, 12hrs and 24 hrs after start of therapy
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Secondary Outcome(s)
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Our secondary outcomes will include the following:
1. The incidence of raised ICP (ONSD5.0 mm) in severe pre-eclampsia prior to MgSO4 therapy.
2. Correlation of ONSD with serum magnesium levels at pre-defined time intervals.
3. Maternal haemodynamic changes following MgSo4 therapy.
4. Changes in neurological signs and symptoms following MgSO4 therapy.
Timepoint: Prior to start of MgSO4 therapy and at 4hr, 12hrs and 24 hrs after start of therapy
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Source(s) of Monetary Support
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PGIMER, Sector 12, Chandigarh, India
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Ethics review
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Status: Approved
Approval date: 08/12/2015
Contact:
Institutional Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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