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Collection of ultrasound images in early pregnancy and in women with a prescription for pelvic scan to build a software that will help the sonologist analyze automatically normal or abnormal ultrasound images in the early first trimester of pregnancy.

Prospective ultrasound data collection of normal and abnormal obstetric and gynecological cases to develop an artificial intelligence algorithm - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/09/027986
Enrollment
250
Registered
2020-09-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Philips India Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria for subject selection 1.Female patients, aged 18 years or more, presenting for a routine or referred obstetric or a gynaecological ultrasound scan 2.For obstetric cases only: a.An ultrasound gestational age between 5 to 10 weeks and 6 days of gestation for normal pregnancies b.A gestational age inferior to 14 weeks for abnormal pregnancies (ectopic pregnancy, blighted ovum and other types of pregnancy loss, hydatiform mole, etc.) c.Singleton pregnancy or multiple pregnancy d.Normal pregnancy or abnormal pregnancy (abnormal early first trimester conditions such as ectopic pregnancy, blighted ovum and other types of pregnancy loss, hydatiform mole, etc.) 3.For gynaecologic cases only: Subject presenting with a normal or abnormal pelvic scan 4.Subject willing and able to provide informed consent

Exclusion criteria

Exclusion criteria: 1.Subject aged below 18 years. 2.For obstetric cases only: a.Subject with a pregnancy younger than 5 and equal or older than 11 weeks for normal pregnancies. b.Subject with a pregnancy superior to 14 weeks for abnormal pregnancies. 3.Subject presenting with fever or hemorrhagia or any condition that needs emergency care (as per investigatorâ??s discretion). 4.Subject with neurological or psychiatric disorders or other disorders that affect the subjectâ??s understanding of the information provided with the consent form. 5.IIliterate subjets and subjects unwilling or unable to provide informed consent.

Design outcomes

Primary

MeasureTime frame
This is a data collection study, there are no specific primary clinical outcome other than collecting the ultrasound data as per the clinical Protocol. The primary endpoint of the study will be reached when 125 subjects with data validated by the Sponsor have been enrolled at each site. Timepoint: 31st May 2021—

Secondary

MeasureTime frame
NATimepoint: NA—

Countries

India

Contacts

Public ContactPallavi Vajinepalli

Philips India Ltd

pallavi.vajinepalli@philips.com9986375873

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026