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.
- Registration Number
- CTRI/2020/09/027986
- Lead Sponsor
- Philips India Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method This is a data collection study, there are no specific primary clinical outcome other than collecting the ultrasound data as per the clinical <br/ ><br>Protocol. The primary endpoint of the study will be reached when <br/ ><br>125 subjects with data validated by the Sponsor have been enrolled at each site. <br/ ><br>Timepoint: 31st May 2021
- Secondary Outcome Measures
Name Time Method ATimepoint: NA