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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05433519
• Other study ID #: 21-3115
• Status: Completed
• Start date: July 27, 2022
• Est. completion date: November 13, 2023

Study information

• Verified date: December 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: November 13, 2023
• Est. primary completion date: May 31, 2023
• Gender: Female
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gestational Age
• Machine Learning
• Pregnancy Related

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina
Zambia	University Teaching Hospital	Lusaka

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Bill and Melinda Gates Foundation

Countries where clinical trial is conducted

United States,  Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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