- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06340971
Air Pollution and Pregnancy (PTB)
The Effects of Air Pollution on Pregnancy and Adverse Birth Outcomes
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.
Study Overview
Detailed Description
Preterm birth is the leading cause of neonatal morbidity and mortality worldwide. Children born prematurely have higher rates of cerebral palsy, sensory deficits, learning disabilities and respiratory illness. In the UK, approximately 60,000 babies are born prematurely each year. This is equivalent to 1 in 9 pregnancies in England and the numbers increase to 1 in every 7 pregnancies in London. In around 40% of cases, the cause of preterm birth are unknown. Current algorithms to predict preterm birth are limited in their ability to identify women at highest risk of delivering preterm and do not consider genetic, lifestyle and environmental circumstances within their prediction. With the rapid development of machine learning and deep learning, it is now possible to develop models which can consider a higher number of variables within their predictive algorithm, to formulate a patient specific prediction of risk. There is growing evidence that maternal exposure to air pollution during pregnancy is associated with an increased risk of preterm birth. Exposure to air pollution may be associated with poor placental function, pre-eclampsia, and poor fetal growth although there is limited data on these adverse pregnancy outcomes, all of which can lead to preterm birth. At present, many of the recent epidemiological studies in this area lack detailed and matching clinical data sets without gaps in electronic records.
This study aims to:
- Link data on air pollution exposure with highly detailed clinical data sets extracted from patient electronic health records from University College London Hospital NHS Trust (UCLH)
- Develop a computational model which can accurately predict the gestation at which a patient will deliver in weeks and days
- Using the model, identify the timepoints in pregnancy that air pollution has the greatest impact on pregnancy outcomes
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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-
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London, United Kingdom, E14NS
- Recruiting
- Tina Chowdhury
-
Contact:
- Tina Chowdhury
- Phone Number: 7560 0207882
- Email: t.t.chowdhury@qmul.ac.uk
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Contact:
- Rhona Atkins
- Phone Number: 7272 0207882
- Email: rhona.atkin@nhs.net
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London, United Kingdom, NW1 2PG
- Recruiting
- Anna David
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Contact:
- Yaa Acheampong
- Phone Number: 6164 020 3447
- Email: y.acheampong@nhs.net
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Contact:
- Anna David
- Phone Number: 9400 0203 447
- Email: a.david@nhs.net
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Machine learning model to predict the risk of preterm birth and adverse birth outcomes
Time Frame: 36 months
|
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'.
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36 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Machine learning model to predict how air quality increases the risk of preterm birth and adverse birth outcomes
Time Frame: 42 months
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This model will also review the temporal sequence of events within a patient's medical history and current pregnancy, identifying significant interactions.
Other adverse pregnancy outcomes such as birthweight, birthweight centile, pre-eclampsia, small for gestational age, fetal growth restriction will also be studied.
|
42 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 331247
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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