MedPath

A data collection study to improve the speed and ease of use when performing ultrasound scanning of the heart of babies in pregnant women.

Phase 1
Registration Number
CTRI/2019/09/021462
Lead Sponsor
Philips India Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Female patients, aged 18 years or more, presenting for a routine or referred US scan with:

A pregnancy equal or above 17 weeks of gestation

Singleton pregnancy or multiple pregnancy

Normal pregnancy or abnormal pregnancy (maternal or fetal conditions)

Willing and able to provide informed consent

Exclusion Criteria

Subject aged below 18 years.

Subject with a pregnancy younger than 17 weeks.

Subjects (mothers) presenting with fever or hemorrhagia or any condition that needs emergency care (as per investigatorâ??s discretion).

Subject (mother) with neurological or psychiatric disorders or other disorders that affect the subjectâ??s understanding of the information provided with the consent form.

Subject unwilling or unable to provide informed consent.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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