A research study for detection of cardiac disease during pregnancy using a novel noninvasive device.

Not yet recruiting

• Conditions: Other specified pregnancy relatedconditions,

• Registration Number: CTRI/2019/01/017308
• Lead Sponsor: Audicor Cardiometrics PVT LTD

Brief Summary

Cardiac disease during pregnancy is aserious complication for both the mother and fetus. However, if detected early,treatment is available and effective in reducing both morbidity and mortality.Acoustic cardiography combined with medical history, symptoms and other metricssuch as blood pressure can provide safe and effective cardiac disease screeningduring pregnancy with minimal discomfort or risk.

Theprimary goal of this study is to evaluate whether the combination ofsimultaneously recorded ECG and heart sounds with advanced signal processinganalysis (acoustic cardiography) can improve the diagnosis of heart diseaseduring pregnancy. Acoustic cardiography produces measurements that reflect bothsystolic and diastolic function in addition to standard ECG parameters andrhythm information. This technology will be used in combination with medicalhistory, symptoms and blood pressure in a time effective screening systemdesigned specifically to be used during pregnancy and post-partum

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-02
• Last Update Posted: 2019-01-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Pregnancy, less than 30 Weeks 2.
• Age 18 years or older.

Exclusion Criteria

• Known allergic reaction to adhesive used in ECG electrodes 2.
• Any sore, incision or skin rash in the area of the upper left chest where the Audicor device would be placed 3.
• History of pre-eclampsia or pregnancy induced hypertension in previous pregnancy.
• Recent history, <12 months, stroke MI or cardiac arrest or peripheral vascular disease.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cardiography during pregnancy and post-partum.	Initial visit to 6 months after pregnancy
Evaluation of the performance of cardiac disease screening using acoustic	Initial visit to 6 months after pregnancy

Trial Locations

Locations (1)

Mazumdhar Shaw Medical Center, a unit of Narayana Hrudayalaya Ltd; 🇮🇳 Rural, KARNATAKA, India

Mazumdhar Shaw Medical Center, a unit of Narayana Hrudayalaya Ltd

🇮🇳Rural, KARNATAKA, India

Dr Lavanya Kiran

Principal investigator

9845689827

drlavanya_kiran@yahoo.co.in