Machine Learning Miscarriage Management Clinical Decision Support Tool Study (MLMM)

April 22, 2024 updated by: Imperial College London

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  • Artificial intelligence discovery science: Algorithm Development based on a retrospective Audit of approximately 1000 cases of miscarriage
  • To determine the reliability of the tool with test data sets
  • To increase the sensitivity and specificity of the decision aid by widening the data collection to multiple sites and testing the algorithm with prospective data

The study will be conducted at Queen Charlotte's and Chelsea Hospital at Imperial College Healthcare NHS Trusts (Primary Centre of the study).

This is a multi-centre retrospective, cohort observational study.

The study will be conducted over a minimum of three years to enable sufficient time to go through the retrospective data and collate test data sets.

Retrospective annonymised cases of missed miscarriage and incomplete miscarriage managed at Imperial College Healthcare NHS Trust will be analyse:

For each case the following clinical features will be collated and outcomes:

  • 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

All data will be collected retrospectively and annonymised.

Following data collection, machine learning models and feature reduction methods will be applied to determine the best performing model to predict success or failure of expectant or medical management of miscarriage respectively.

The next phase will include a prospective audit to collect data and test the predictive power of the MLM clinical decision support tool.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Final outcome data unavailable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Expectant Management: Conservative management if miscarriage with follow-up booked in 2 weeks to determine whether complete miscarriage has occurred.
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
Medical Management: Misoprostol taken to manage first trimester miscarriage, with follow-up booked in 2 weeks to determine whether complete miscarriage has occurred.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Machine learning predictive model development for miscarriage management outcomes.
Time Frame: Jan 2023- June 2024
Machine learning predictive model development based on a retrospective audit of approximately 1000 cases of miscarriage.
Jan 2023- June 2024

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prospective audit to test and validate predictive model
Time Frame: July 2024-June 2025
To increase the sensitivity and specificity of the decision aid by widening the data collection to multiple sites and testing the machine learning model with prospective data.
July 2024-June 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23QC8155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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