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CTRI Number  CTRI/2025/08/092400 [Registered on: 05/08/2025] Trial Registered Prospectively
Last Modified On: 04/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Predictor of Pregnancy outcome in preeclampsia.  
Scientific Title of Study   Prediction of pregnancy outcome in preeclampsia using optic nerve sheath diameter.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Divya Pandey 
Designation  Professor 
Affiliation  VMMC and Safdarjung Hospital 
Address  Department of Obstetrics and Gynaecology, VMMC and Safdarjung Hospital, MG Road, New Delhi, India
MG Road, New Delhi, India
South
DELHI
110029
India 
Phone  8860198440  
Fax    
Email  dr_devya1@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Farha Naaz 
Designation  Post graduate student 
Affiliation  VMMC and Safdarjung Hospital 
Address  Department of Obstetrics and Gynaecology, VMMC and Safdarjung Hospital, MG Road, New Delhi, India

South
DELHI
110029
India 
Phone  917022586886  
Fax    
Email  nfarha4242@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Farha Naaz 
Designation  Post graduate student 
Affiliation  VMMC and Safdarjung Hospital 
Address  Department of Obstetrics and Gynaecology, VMMC and Safdarjung Hospital, MG Road, New Delhi, India


DELHI
110029
India 
Phone  917022586886  
Fax    
Email  nfarha4242@gmail.com  
 
Source of Monetary or Material Support  
VMMC and Safdarjung Hospital,MG Marg,Delhi-110029 
 
Primary Sponsor  
Name  VMMC and Safdarjung Hospital 
Address  VMMC and Safdarjung Hospital,MG Marg,Delhi-110029 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Divya Pandey  VMMC and Safdarjung Hospital, MG Marg, Delhi-110029  Department of Obstetrics and Gynaecology,VMMC and Safdarjung Hospital,MG Marg, Delhi-110029
South
DELHI 
8860198440

dr_devya1@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, VMMC and Safdarjung Hospital, Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O14||Pre-eclampsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Antenatal women with POG more than 28 weeks with preeclampsia  
 
ExclusionCriteria 
Details  1. Known neurological disorders (eg epilepsy, intracranial space-occupying lesion, trauma, hydrocephalus)
2. Ocular disease affecting optic nerve (optic neuritis, orbital cellulitis, glaucoma)
3. Chronic renal disease / chronic liver disease not related to pre-eclampsia
4. Long-term Magnesium therapy or diuretics
5. Multiple pregnancy
6. Fetal anomalies
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Correlation of pregnancy outcome in preeclampsia with optic nerve sheath diameter
diameter.  
baseline,24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Sensitivity, specificity, predictive value & cut-off of Optic Nerve Sheath diameter for predicting adverse pregnancy outcomes in preeclampsia.
 
Baseline 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Pre-eclampsia, affecting 2–8% of pregnancies worldwide, is a major cause of maternal and perinatal complications.Early risk identification enables timely diagnosis, early intervention and better management which can reduce associated morbidity and mortality. Therefore, prediction models are being studied to help early identification and timely intervention for an optimal feto-maternal outcome. There is an ongoing quest to look for an economical yet effective alternative.In hypertensive disorders of pregnancy, particularly preeclampsia and eclampsia, raised intracranial pressure (ICP) can occur due to cerebral oedema, leading to potential complications like intracranial hemorrhage and seizures. Its clinically difficult to detect early cerebral edema and raises ICP.
There is a need of some bedside noninvasive, safe method of detection. OPTIC NERVE SHEATH DIAMETER measured by ultrasound can be an important device for prediction of raised ICP with the added
benefit of it being a bedside/ point of care test.

OPTIC NERVE SHEATH DIAMETER has been utilized in various neurological complications. Pré-eclampsia is a complex condition which affects the multiple organ systems, including the central nervous system.
Based on this background, this study is designed to study the pregnancy outcome in women with preeclampsia using optic nerve sheath diameter. 
AIM(S) & OBJECTIVE(S)

AIM: To predict the pregnancy outcomes in women with preeclampsia using optic nerve sheath diameter
OBJECTIVE:
To measure and correlate the optic nerve sheath diameter with the pregnancy outcome in women with preeclampsia.

MATERIAL AND METHODS
This study will be conducted in the Department of Obstetrics and Gynecology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi.
Type of study: Prospective observational study
Duration of study:18months
Study setting: Department of Obstetrics and Gynecology, and Department of Radiodiagnosis
     Vardhman Mahavir Medical College and Safdarjung Hospital,
      New Delhi
Study population: All antenatal women meeting the eligibility criteria Inclusion criteria:
1. Singleton Pregnancy with period of gestation>28 weeks with preeclampsia
Exclusion criteria:
1. Known neurological disorders (eg epilepsy, intracranial space-occupying lesion, trauma, hydrocephalus)
2. Ocular disease affecting optic nerve (optic neuritis, orbital cellulitis, glaucoma)
3. Chronic renal disease / chronic liver disease not related to pre-eclampsia
4. Long-term Magnesium therapy or diuretics
5. Multiple pregnancy
6. Fetal anomalies

METHODOLOGY
This study titled “PREDICTION OF PREGNANCY OUTCOME IN PRE ECLAMPSIA
USING OPTIC NERVE SHEATH DIAMETER” is a prospective observational study that will be performed on 200 participants over 18 months duration in the Dept of Obstetrics and Gynaecology, VMMC and SJH, New Delhi. All pregnant women will be screened for eligibility as per inclusion and exclusion criteria of the study. Informed consent will be taken. Data collection as per the study performa will be done, the management will be done as per the departmental protocol.
Measurement of –All enrolled women will be followed and pregnancy outcome will be noted in terms of adverse materno-fetal outcomes.
Definition of adverse outcome:
1-Maternal:
• Progression to eclampsia
• ICU admission
• Abruption
• Neurological complications
• Maternal mortality
 2-Fetal:
• Preterm birth
• Perinatal mortality
Optic nerve sheath diameter measurement will be done once the patient is planned for termination of pregnancy using ultrasonography machine: ESAOTE S.P. A model: MylabX75 with linear probe of frequency between 4-15MHz.The patients will be placed in the supine position, with their eyes closed and head in the neutral position elevated to 30 degrees. The transducer will be gently placed on the temporal region of the upper eyelid and slightly tilted caudally and medially until an image of the orbit was obtained on the axial axis, showing the entry point of the optic nerve into the ocular globe. The image will be taken until cross-sectional measurement of the optic nerve sheath 3 mm from its entry into the ocular globe. The procedure will be performed three times on each eye, with the final value recorded in millimeters corresponding to the mean of all the measurements. All women will be followed till delivery and pregnancy outcome will be recorded as defined above.

OUTCOMES:
1. Correlation of pregnancy outcome in preeclampsia with optic nerve sheath diameter.
2. Sensitivity, specificity, predictive value and cut-off of optic nerve sheath diameter for predicting adverse pregnancy outcomes in preeclampsia.

 
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