NCT06340971

Brief Summary

We are an inter-disciplinary team of UK scientists with expertise in obstetrics, women's and child health, epidemiology, climate science, inflammation, computational modelling, machine learning and artificial intelligence. Together we have a long history with existing strengths underlying preterm birth research that crosses multiple disciplines and an excellent track record of publications and awards leading research in preterm birth. We aim to develop and validate a deep learning model to predict the risk of preterm birth and other adverse pregnancy outcomes using data from EPIC electronic health records at University College London Hospital Trust (UCLH) for a cohort of 18000 patients. We will obtain corresponding data on exposure to ambient pollution using non-identifiers for postcode (area) and date of delivery (month). The model will review the temporal sequence of events within a patient's medical history and current pregnancy, identifying significant interactions and will predict the risk of preterm birth. It will also determine the threshold and gestation at which pollution exposure has the greatest impact.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200,000

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Nov 2024

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Nov 2024Nov 2029

First Submitted

Initial submission to the registry

March 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2029

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2029

Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

5 years

First QC Date

March 26, 2024

Last Update Submit

November 21, 2025

Conditions

Keywords

Preterm birthPregnancyPremature birthAir pollutionAir quality

Outcome Measures

Primary Outcomes (1)

  • Machine learning model to predict the risk of preterm birth and adverse birth outcomes

    We aim to develop a deep learning algorithm to predict the risk of preterm birth and other adverse pregnancy outcomes using data from electronic health records and a spatiotemporal model for ambient pollution levels within London. The model will consider personal, lifestyle and environmental factors alongside traditional risk factors to predict the gestation of pregnancy that delivery is most likely to occur. This can be classified as 'term', 'late preterm', 'moderate preterm', 'very preterm' and 'extreme preterm'.

    36 months

Secondary Outcomes (1)

  • Machine learning model to predict how air quality increases the risk of preterm birth and adverse birth outcomes

    42 months

Interventions

PolicyOTHER

We will work with stakeholders' policy groups e.g. RCOG, RCM, RCP and policy makers e.g. Department for Health and Social Care, Transport Emissions at the Greater London Authority or Mayor of London's office to disseminate our findings and develop public health messages. We aim to develop guidance on how pregnant women and their families can reduce their exposure to air pollution by highlighting for example travel routes with less pollution and wear face masks.

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women over the age of 18 years old
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We aim to include data from pregnant women who delivered at UCLH from 2019 when EPIC was launched and until the end of 2023. There is no specified upper age range for this study. To improve inclusivity, we will aim to collect information from all women booking and delivering at UCLH to ensure minority ethnic groups and patients with social deprivation or with additional pregnancy complicating disorders are included within our dataset.

You may qualify if:

  • We aim to include data from pregnant women who delivered at University College London Hospitals from 2019 onwards after the start of the EPIC electronic patient record. The is no specified age range for this study, so as to improve inclusivity. We also aim to represent minority ethnic groups and patients with social deprivation within our dataset.

You may not qualify if:

  • We will exclude data from patients with an incomplete duration of follow-up due to transfer of antenatal care for delivery at another trust. Patients with incomplete past obstetric history data, inaccurate estimations of gestational age (e.g. due to late booking of the pregnancy) and missing data for 'postcode of usual address' will also be excluded. Patients who are less than 18 years of age will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tina Chowdhury

London, E14NS, United Kingdom

RECRUITING

Anna David

London, NW1 2PG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Policy

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Health Care Economics and Organizations

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2024

First Posted

April 2, 2024

Study Start

November 1, 2024

Primary Completion (Estimated)

October 31, 2029

Study Completion (Estimated)

November 30, 2029

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Data from the EPIC electronic health records database will be anonymized at UCLH to create a secondary dataset with anonymized identifier for patient identifier, postcode (area) and delivery date (month). Raw data screened. Patients excluded according to criteria.

Locations