| CTRI Number |
CTRI/2023/09/057867 [Registered on: 20/09/2023] Trial Registered Prospectively |
| Last Modified On: |
18/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A comparative study of the importance of two-dimensional Echocardiography in Hypertensive disorders of pregnancy (HDP) and normal pregnant women, as well as its effect on maternal and fetal outcome.
|
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Scientific Title of Study
|
"A prospective comparative study of significance of two-Dimensional Echocardiography in Hypertensive disorders of pregnancy (HDP) compared to normal pregnancy and its effect on Fetomaternal outcomes". |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRMADDERLA SOWMYA |
| Designation |
JUNIOR RESIDENT (PG) |
| Affiliation |
SHRI BM PATIL MEDICAL COLLEGE |
| Address |
OBG OPD NO2 DEPT OF OBG SHRI BM PATIL MEDICAL COLLEGEHOSPITAL AND RESEARCH CENTRE, BANGARAMMA SAJJAN CAMPUS, SOLAPUR ROAD, VIJAYAPURA-586103
Bijapur
KARNATAKA
586103
India |
| Phone |
8309400654 |
| Fax |
|
| Email |
sowmya.madderla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRSHREEDEVI KORI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SHRI BM PATIL MEDICAL COLLEGE |
| Address |
OBG OPD NO2 DEPT OF OBG SHRI BM PATIL MEDICAL COLLEGEHOSPITAL AND RESEARCH CENTRE, BANGARAMMA SAJJAN CAMPUS, SOLAPUR ROAD, VIJAYAPURA-586103
Bijapur
KARNATAKA
586103
India |
| Phone |
9113896750 |
| Fax |
|
| Email |
shree_kori@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DRSHREEDEVI KORI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SHRI BM PATIL MEDICAL COLLEGE |
| Address |
OBG OPD NO2 DEPT OF OBG SHRI BM PATIL MEDICAL COLLEGEHOSPITAL AND RESEARCH CENTRE, BANGARAMMA SAJJAN CAMPUS, SOLAPUR ROAD, VIJAYAPURA-586103
Bijapur
KARNATAKA
586103
India |
| Phone |
9113896750 |
| Fax |
|
| Email |
shree_kori@yahoo.com |
|
|
Source of Monetary or Material Support
|
| SHRI B.M PATIL MEDICAL COLLEGE |
|
|
Primary Sponsor
|
| Name |
Shri BM Patil medical college and hospital |
| Address |
OBG OPD NO2 DEPT OF OBG SHRI BM PATIL MEDICAL COLLEGEHOSPITAL AND RESEARCH CENTRE, BANGARAMMA SAJJAN CAMPUS, SOLAPUR ROAD, VIJAYAPURA-586103 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DRMADDERLA SOWMYA |
SHRI BM PATIL MEDICAL COLLEGE HOSPITAL |
OBG OPD NO.2 ,DEPT OF OBG .
Bijapur
KARNATAKA |
08309400654
sowmya.madderla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, BLDE (DEEMED TO BE UNIVERSITY), VIJAYAPURA. |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O141||Severe pre-eclampsia, (2) ICD-10 Condition: O169||Unspecified maternal hypertension,unspecified trimester, |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women with a normal singleton pregnancy from 28 weeks to 42weeks period of gestation.
Women with gestational hypertension (BP≥140/90mmHg after 20 weeks of pregnancy) from 28
weeks to 42 weeks period of gestation.
Women with mild preeclampsia (gestational hypertension with proteinuria)
Women with severe preeclampsia (gestational hypertension with proteinuria with end-organ
damage)
Women with imminent eclampsia (preeclampsia with imminent signs) from 28 weeks to 42 weeks
period of gestation. |
|
| ExclusionCriteria |
| Details |
Women who are not consenting to the study.
Women with chronic hypertension.
Women with eclampsia.
Women with Gestational age less than 28 weeks.
Women in active labor.
Multiple pregnancy, severe anemia patients.
Known cardiac disease (e.g., structural heart disease, coronary heart disease, cardiomyopathies, etc.
Connective tissue disorders.
Renal impairment.
Diabetes mellitus |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
To know the two dimensional echocardiographic changes in pregnant women with HDPs compared to normal pregnant women.
|
24hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To analyze the correlation between Echocardiographic abnormalities and fetomaternal outcome of pregnant women with HDPs compared to that of normal pregnant women.
|
24hours |
|
|
Target Sample Size
|
Total Sample Size="142"
Sample Size from India="142"
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)
|
29/09/2023 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
1) All singleton pregnant women from 28 weeks to 42weeks gestation meeting the inclusion criteria will be screened for hypertension by measuring their blood pressure using a standard auscultatory method with the help of a mercury sphygmomanometer. Systolic and diastolic blood pressure will be measured in the sitting position in the right arm at the level of the heart.6 Heart rate is measured along with mean arterial pressure. 2) The patients who are normotensive will be divided into one group who will be serving as controls, and a departmental ECHO will be done. 3) The patients who will show B.P.> 140/90mmHg on two occasions 4hrs apart will be considered hypertensive and will be divided into another group serving as cases. 4) Bed side urine albumin test done by taking 2ml urine with 2ml of sulphosalicylic acid added and checked for cloudiness to differentiate gestational hypertension with preeclampsia and as a routine protocol, all basic investigations and departmental ECHO will be done. 4) In patients who are in early pregnancy (28weeks to 32weeks), again repeat 2DECHO will be done near term. 5) Data will be compared in terms of echocardiographic findings and structural anomalies on echocardiography in normal pregnant women with HDPs. 6) Data will also be compared in terms of complications of maternal outcomes like Congestive Cardiac Failure(C.C.F.), Atrial fibrillation, hypertensive crisis, cardiomyopathy, Intensive Care Unit(I.C.U.) admissions, maternal mortality, and complications of fetal outcomes like Intra Uterine Growth Retardation(I.U.G.R.), preterm, Neonatal Intensive care Unit (NICU) admissions, Intra Uterine Deaths. A cardiologist’s opinion will be taken in patients with abnormal echocardiographic findings, and a decision regarding the plan of treatment will be taken. |