Health Condition 1: null- Pregnancy
Conditions
Interventions
None listed
Sponsors
Philips India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Aged 18 years or more, presenting for a routine or referred US scan with:A pregnancy equal or above 15 weeks of gestation, Singleton pregnancy or Twin pregnancy, Normal pregnancy or Suspected abnormal pregnancy (e.g. fetal malformations, placenta accreta, TTTS, etc.) with a medical indication for MRI study
Exclusion criteria
Exclusion criteria: 1.Patients aged less than 18 years, 2.Patients with a pregnancy younger than 15 weeks. 3.Multiple pregnancies with more than 2 foetuses. 4.Subjects (mothers) presenting with fever or hemorrhagia or any condition that needs emergency care (as per investigatorâ??s discretion).5.Subjects (mothers) with neurological or psychiatric disorders or other disorders that affect the subjectâ??s understanding of the information provided with the consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This is a data collection study, there are no specific primary clinical outcome other than collecting the ultrasound data as per clinical protocol.The primary endpoint of the study will be reached when: 50 subjects with data quality validated by the sponsor have been enrolled (see â??first analysis of dataâ?? above and pass/fail criteria in section 7-Statistical considerations).Timepoint: 50 subjects with data quality validated by the sponsor have been enrolled (see â??first analysis of dataâ?? above and pass/fail criteria in section 7-Statistical considerations).Or we have reached a number of samples that have allowed the development of algorithms sufficiently accurate to be tested in a validation study. | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactPallavi Vajinepalli
Philips Research
Outcome results
None listed