Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Origin Medical Research Lab, India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Normal and Singleton pregnancies with no clinical indications of fetal anomaly prior to the exam 2. Gestational age between 11weeks+ 0 days to 13 weeks +6 days by last menstrual date(LMP) or ultrasound report if uncertain LMP
Exclusion criteria
Exclusion criteria: 1. Multiple pregnancies 2. Non-readable images(i.e., images with excessive shadows)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Evaluate the diagnostic agreement between OMEA(Origin Medical Exam Assistant, a browser-based software as a medical device)- assisted examinations and traditional examinations 2. Assess the precision of fetal/obstetric measurements obtained with OMEA compared to standard practices 3. Determine the feasibility of introducing OMEA in the real-clinical settingTimepoint: Gestational age of fetus between 11 to 13 weeks and 6 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. In accordance with practice guidelines, Sensitivity and Specificity of the OMEA in : a) Detecting diagnostic views from obstetric ultrasound examinations b) Identifyin anatomical structures/landmarks within the diagnostic views from obstetric ultrasound examinations c) Annonating the anatomical structures/landmarks identified within the diagnostic views d) Determinig the quality criteria required for clinical evaluation of diagnostic views 2.Reproducibility and repeatability of the OMEA in performing obstetric measurements 3. Workflow efficiency of OMEA for obstetric measurements performed on obstetric ultrasound examinations at relevant anatomical landmarksTimepoint: Gestational age of fetus between 11 to 13 weeks and 6 days | — |
Countries
India
Contacts
Public ContactDr K Aparna Sharma
AIIMS New Delhi
Outcome results
None listed