Diagnostic Accuracy of a Novel Machine Learning Algorithm to Estimate Gestational Age

Z 32104 - Diagnostic Accuracy of a Novel Machine Learning Algorithm to Estimate Gestational Age

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Machine Learning; Gestational Age

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.

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
• Zambia
  • Lusaka, Zambia
    • University Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women at 14 weeks or earlier gestation

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Pregnant Women; Pregnant women with gestational age established at less than 14 weeks of gestation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of FAMLI Technology	Difference in mean absolute error (MAE) of the index test and clinical reference standard in the primary evaluation window	From 14 through 27 completed weeks of gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean absolute error in the secondary evaluation window	Difference in mean absolute error (MAE) of the index test and clinical reference standard in the secondary evaluation window	From 28 through 36 completed weeks of gestation

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Bill and Melinda Gates Foundation
• Investigators: Principal Investigator: Jeff Stringer, MD, University of North Carolina

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2022
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): November 13, 2023

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: June 21, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 21-3115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: 9-36 months following publication
• IPD Sharing Access Criteria: noted above

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No