None listed
Conditions
Interventions
None listed
Sponsors
Philips India Ltd
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 100 subjects with data validated by the sponsor have been enrolled at each site (including 10 abnormal fetal hearts) or we have reached a number of samples that have allowed the development of algorithms sufficiently accurate to be tested in a validation study. Timepoint: Estimated completion date: 28th February 2019 | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: nil | — |
Countries
India
Contacts
Public ContactPallavi Vajinepalli
Philips India Ltd
Outcome results
None listed