Gestational Age, Machine Learning, Pregnancy Related
Conditions
Brief summary
This is a prospective cohort study of women enrolled early in pregnancy, with randomization to determine the timing of three follow-up visits in the second and third trimester. At each of these follow-up visits, investigators will assess gestational age with the FAMLI technology and compare that estimate to the known gestational age established early in pregnancy.
Detailed description
The primary purpose of this research is to assess the diagnostic accuracy of the FAMLI Technology, a novel machine learning-based tool for gestational age assessment that can run on a smart phone or tablet. Study staff will enroll 400 pregnant volunteers prior to 14 completed gestational weeks and obtain accurate ground truth gestational age dating with standard ultrasound biometry, using the crown-rump length. These participants will then be asked to return for three follow-up visits, which will include a routine sonogram performed by a trained sonographer and the collection of a set of blind sweep cineloop videos using a low-cost, battery-operated device. The research will be conducted in Chapel Hill, North Carolina (at the University of North Carolina Hospital and/or sites associated with UNC OBGYN) and in Lusaka, Zambia (at the University Teaching Hospital or Kamwala District Health Centre). Approximately equal numbers of participants will be enrolled from each country.
Interventions
None listed
Sponsors
Bill and Melinda Gates Foundation
University of North Carolina, Chapel Hill
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 59 Years
Inclusion criteria
* 18 years of age or older * viable intrauterine pregnancy at less than 14 0/7 weeks of gestation * ability and willingness to provide written informed consent * intent to remain in current geographical area of residence for the duration of study * willingness to adhere to study procedures
Exclusion criteria
* maternal body mass index = 40 kg/m\^2 * multiple gestation (i.e., twins or higher order) * major fetal malformation or anomaly * any other condition (social or medical) that, in the opinion of the study staff, would make study participation unsafe or complicate data interpretation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of FAMLI Technology | From 14 through 27 completed weeks of gestation | Difference in mean absolute error (MAE) of the index test and clinical reference standard in the primary evaluation window |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean absolute error in the secondary evaluation window | From 28 through 36 completed weeks of gestation | Difference in mean absolute error (MAE) of the index test and clinical reference standard in the secondary evaluation window |
Countries
United States, Zambia
Outcome results
None listed