This study is a prospective data collection study.

The main objective of the study is to collect 2D, M-mode and 3D ultrasound imaging in the early first trimester pregnancies (5 weeks to 10 weeks and 6 days) and in gynaecological subjects to check the feasibility of automated detection and quantification in early normal and abnormal pregnancies. In order to build clinically useful algorithms, the data should represent a variety of situations that is found in current practice; the dataset should hence contained at least the following:

·      First trimester pregnancies (normal and abnormal such as ectopic pregnancies)

·      Surrounding anatomical structures (such as ovaries, Fallopian tubes and Douglas cul-de-sac)

·      Imaging data with features that can be confused with early pregnancy (such as normal and abnormal uterine findings in non-pregnant women)

·      Images acquired with different ultrasound modes: standard 2D view, M-mode (fetal heart rate), 3D.

The data collection study will be performed at Gunasheela Surgical and Maternity Hospital, Gunasheela IVF centre, Bangalore (site 1) and Thane Ultrasound centre, Mumbai (site 2), both are referral centres in India.

De-identified 2D, 3D ultrasound images and videos of 250 women presenting with: normal first trimester pregnancies (180), abnormal first trimester pregnancies (30), normal (20) or abnormal (20) pelvic scan will be shared with the sponsor (125 subjects total per site).

Data collection will be done on the commercial registered ultrasound devices of the centres (Philips Affiniti 50/70, Philips Epiq 5/7) and on a commercially released ultrasound device from the sponsor (ClearVue 650/850). All devices will be used within their intended use.

Study will be registered in the CTRI website as per local regulations (India).