| CTRI Number |
CTRI/2021/07/034561 [Registered on: 02/07/2021] Trial Registered Prospectively |
| Last Modified On: |
04/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the fetomaternal outcome of decreased sodium level in the patients of one of the subtypes of hypertensive disorders in pregnancy and its association with the severity of the disorder |
|
Scientific Title of Study
|
To study the correlation of hyponatremia with the fetomaternal outcome in patients of preeclampsia with severe features and to study its association as a marker of the severity of preeclampsia |
| Trial Acronym |
HOPE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramya Lasmi R |
| Designation |
Junior resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Room no 10,
Department of Obstetrics and Gynecology, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9442269624 |
| Fax |
|
| Email |
ramyalasmiom26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Chopra |
| Designation |
Additional Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Room no 10,
Department of Obstetrics & Gynaecology,PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009351 |
| Fax |
|
| Email |
drseemachopra@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramya Lasmi R |
| Designation |
Junior resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Room no 10
Department of Obstetrics and gynecology, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9442269624 |
| Fax |
|
| Email |
ramyalasmiom26@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Sector 12,Chandigarh 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ramya Lasmi R |
PGIMER |
Department of Obstetrics and gynecology, labour room
Chandigarh
CHANDIGARH |
09442269624
ramyalasmiom26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O141||Severe pre-eclampsia, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1)Pregnant women with the period of gestation between 20 to 40 weeks admitted in labour ward with blood pressure more than or equal to 140/90 mmHg measured on 2 occasions 4 hours apart consenting to be enrolled in study.
2)Age more than or equal to 18 years
3)All patients falling under the ACOG Criteria for severe Preeclampsia |
|
| ExclusionCriteria |
| Details |
1)Pregnant women who do not consent for study
2)Women with chronic kidney disease, liver disease, cardiovascular disease, collagen vascular disease, chronic hypertension, diabetes, neoplasm, with major fetal anomaly, endocrine disorders causing electrolyte imbalance, CNS disorders, on steroids /diuretics |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Fetomaternal outcome in preeclamptic patients with severe features presenting with hyponatremia
2) Association of hyponatremia with the severity of preeclampsia |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of hyponatremia in preeclamptic patients with severe features |
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/07/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective observational study to study the correlation of hyponatremia with the fetomaternal outcome in preeclamptic patients with severe features and to study whether hyponatremia is an independent marker for the severity of preeclampsia.Sample size is 100.The primary outcome is to study the correlation of hyponatremia with the fetomaternal outcome in preeclamptic patients with severe features and to study association of hyponatremia as an independent marker for the severity of preeclampsia.The secondary outcome is to study the prevalence of hyponatremia in preeclamptic patients with severe features. |