Machine Learning Miscarriage Management Clinical Decision Support Tool Study

NCT06384144 | Recruiting

• 1 other identifier: 23QC8155
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Machine learning used to develop an algorithm to determine chance of success with expectant or medical management for an individual patient. Taking into account the following objective measures:

• Demographics: Maternal Age, Parity
• History: Previous CS, Previous SMM/MVA, Previous Myomectomy
• Gestation by LMP
• Presenting symptoms: Bleeding score, Pain score
• USS Measurements: CRL, GS, RPOC 3 dimensions, Vascularity
• Discrepancy between gestation by CRL and LMP Audit to collate 1000 cases and identify features contributing to an algorithm that can predict outcome of miscarriage management for individualized case management.

Conditions

Miscarriage in First Trimester

Outcome Measures

Primary Outcomes (1)

• Machine learning predictive model development for miscarriage management outcomes.

  Machine learning predictive model development based on a retrospective audit of approximately 1000 cases of miscarriage.

  Jan 2023- June 2024

Secondary Outcomes (1)

• Prospective audit to test and validate predictive model

  July 2024-June 2025

Study Arms (2)

Expectant Management of Miscarriage

Cohort that chose to pursue expectant management of miscarriage, final outcome success or failure by day 14 from management choice

Other: Expectant Management of First Trimester Miscarriage

Medical Management of Miscarriage

Cohort that chose to pursue medical management of miscarriage, final outcome success or failure by day 14 from management choice

Other: Medical Management of First Trimester Miscarriage

Interventions

Expectant Management of First Trimester Miscarriage OTHER

Expectant Management: Conservative management if miscarriage with follow-up booked in 2 weeks to determine whether complete miscarriage has occurred.

Expectant Management of Miscarriage

Medical Management of First Trimester Miscarriage OTHER

Medical Management: Misoprostol taken to manage first trimester miscarriage, with follow-up booked in 2 weeks to determine whether complete miscarriage has occurred.

Medical Management of Miscarriage

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Cases of missed miscarriage and incomplete miscarriage in the first trimester.

You may qualify if:

• Missed miscarriage and incomplete miscarriage less than 14weeks gestation
• Follow-up recorded at 2 weeks

You may not qualify if:

• \- Final outcome data unavailable

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Heatlhcare NHS Trust

London, W12 0HS, United Kingdom

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: January 1, 2023
• Primary Completion: June 1, 2024
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)