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.

Not yet recruiting

Conditions: Severe pre-eclampsia, (2) ICD-10 Condition: O169||Unspecified maternal hypertension,unspecified trimester,

Registration Number: CTRI/2023/09/057867

Lead Sponsor: Shri BM Patil medical college and hospital

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 cardiologistâ€™s opinion will be taken in patients with abnormal echocardiographic findings, and a decision regarding the plan of treatment will be taken.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 142

Inclusion Criteria

Women with a normal singleton pregnancy from 28 weeks to 42weeks period of gestation.
Women with gestational hypertension (BPâ‰¥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.

Exclusion Criteria

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.
Known cardiac disease (e.g., structural heart disease, coronary heart disease, cardiomyopathies, etc.
Connective tissue disorders.
Renal impairment.
Diabetes mellitus.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To know the two dimensional echocardiographic changes in pregnant women with HDPs compared to normal pregnant women.	24hours

Secondary Outcome Measures

Name	Time	Method
To analyze the correlation between Echocardiographic abnormalities and fetomaternal outcome of pregnant women with HDPs compared to that of normal pregnant women.

Trial Locations

Locations (1): SHRI BM PATIL MEDICAL COLLEGE HOSPITAL
🇮🇳
Bijapur, KARNATAKA, India
SHRI BM PATIL MEDICAL COLLEGE HOSPITAL
🇮🇳Bijapur, KARNATAKA, India
DRMADDERLA SOWMYA
Principal investigator
08309400654
sowmya.madderla@gmail.com