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Project Summary

<div class="ck-content" data-wrapper="true" dir="ltr" style="--ck-image-style-spacing: 1.5em; --ck-inline-image-style-spacing: calc(var(--ck-image-style-spacing) / 2); font-family: 'Segoe UI','Helvetica Neue',sans-serif; font-size: 9pt;"><p style="margin: 0cm;"><span style="color:black;font-family:Aptos, serif;font-size:12pt;">Pregnant women are 1.6 times more likely to die after injuries, such as broken bones, compared to non-injured pregnant women. Unlike the United States, there are not many studies in the United Kingdom about how such injuries in pregnancy affect women and their unborn child. This is why advice and treatment from doctors can vary in the United Kingdom. This service evaluation will use data from Bart’s Health NHS Trust to explore how injuries during pregnancy impact mothers and their unborn children. We will look at the health results of both pregnant women with injuries and without injuries to find out what makes pregnant people more likely to have adverse health results after injuries. We hope this work will help doctors provide better care for injured women and prevent adverse health results for mothers and their unborn children. We will discuss our findings with community representatives as well as how to best share this information with the public.</span></p><p style="margin: 0cm;"><span style="color:black;font-family:Aptos, serif;font-size:12pt;"><b>&nbsp;</b></span></p></div>

Detailed Project Description

<div class="ck-content" data-wrapper="true" dir="ltr" style="--ck-image-style-spacing: 1.5em; --ck-inline-image-style-spacing: calc(var(--ck-image-style-spacing) / 2); font-family: 'Segoe UI','Helvetica Neue',sans-serif; font-size: 9pt;"><div style="font-family:'Segoe UI','Helvetica Neue',sans-serif;font-size:9pt;"><div><span style="font-size:12pt;"><span style="line-height:115%;">Obstetric trauma in the UK is rare, affecting approximately 1% of pregnancies, yet it accounts for 20% of non-obstetric maternal deaths. Despite its significant impact, there is a lack of comprehensive research on maternal and foetal outcomes in the UK population, and no national UK obstetric guidelines currently exist. Local guidelines vary considerably, contributing to inconsistencies in care.</span></span><br><br><span style="font-size:12pt;"><span style="line-height:115%;">This evaluation aims to better characterise trauma in pregnancy within Barts Health and identify predictors of adverse maternal and foetal outcomes. To achieve this, we will compare three groups: (1) pregnant individuals who experienced trauma and had adverse obstetric outcomes, (2) pregnant individuals who experienced trauma without adverse outcomes, and (3) pregnant individuals with no trauma exposure.&nbsp;Cohorts and their maternal and foetal outcomes will be identified using the anonymised OMOP-mapped OHDSI dataset from Barts Health. Trauma exposure is defined as the presence of a coded injury or external causation codes (e.g., falls or motor vehicle accidents).</span></span><br><br><span style="font-size:12pt;"><span style="line-height:115%;">This project will serve as a pilot to assess the feasibility of using OMOP-mapped OHDSI data for evaluating maternal and foetal outcomes following trauma. The findings may support the development of a large-scale UK and potentially global study, ultimately informing future national guidelines for the monitoring, follow-up, and management of trauma in pregnancy that would be applied for formally in a separate application should this be considered feasible.</span></span></div><div><br><span style="font-size:12pt;"><span style="line-height:normal;">POPULATION: All pregnant individuals who delivered within Barts Health trust in the OMOP mapped OHDSI database from 2012 to the end of data capture.</span></span></div><div><br><span style="font-size:12pt;"><span style="line-height:normal;">VARIABLES: Exposure to trauma will be based on coded injuries or external causation. Pregnant women will be characterised by demographic information such as age, gestation at trauma, gravidity and parity, ethnicity, other medicine use (analgesia, tranexamic acid (TXA), Low molecular weight heparin (LMWH)), and diagnoses of comorbidities. Foetal and Maternal adverse outcomes at delivery, 42-day post-partum will be identified as well as potential predictors, such as signs, symptoms and investigations.</span></span></div><div><br><span style="color:black;font-size:12pt;"><span style="line-height:normal;">ANALYSES:</span></span></div><ul style="list-style-position: inside; margin-bottom: 13px;"><li style="list-style-position:inside;"><span style="font-size:12pt;"><span style="line-height:115%;">Objective 1: Characterisation of database, including descriptive analysis of patient characteristics, trauma incidence, mechanism, injury severity</span></span></li><li style="list-style-position:inside;"><span style="font-size:12pt;"><span style="line-height:115%;">Objective 2: Comparison of maternal and foetal outcomes between 3 groups using appropriate statistical test</span></span></li><li style="list-style-position:inside;"><span style="font-size:12pt;"><span style="line-height:115%;">Objective 3: Logistic regression to identify predictors of adverse outcomes; Multivariable models adjusted for confounding factors such as age and comorbidities</span></span></li></ul><div><span style="font-size:12pt;"><span style="line-height:normal;"><strong>Outcomes to be measured</strong></span></span><br><span style="font-size:12pt;"><span style="line-height:115%;">Primary Outcome: Characterisation of adverse maternal outcomes at delivery and 42 days postpartum as well as adverse foetal outcomes</span></span><br><span style="font-size:12pt;"><span style="line-height:115%;">Secondary Outcome: Predictive factors for adverse maternal and foetal outcomes</span></span></div><div><br><span style="font-size:12pt;"><span style="line-height:normal;"><strong>Objectives:&nbsp;</strong></span></span><br><span style="font-size:12pt;"><span style="line-height:normal;">The objectives are:</span></span></div><ol style="list-style-position: inside; margin-bottom: 11px;"><li style="list-style-position:inside;margin-bottom:11px;"><span style="font-size:12pt;"><span style="line-height:115%;">To describe the demographic characteristics, incidence, mechanisms of trauma, types of injuries of obstetric trauma patients.</span></span></li><li style="list-style-position:inside;margin-bottom:11px;"><span style="font-size:12pt;"><span style="line-height:115%;">To compare maternal and foetal outcomes between:</span></span><ol style="list-style-position: inside;"><li style="list-style-position:inside;margin-bottom:11px;"><span style="font-size:12pt;"><span style="line-height:115%;">Obstetric trauma patients with adverse outcomes</span></span></li><li style="list-style-position:inside;margin-bottom:11px;"><span style="font-size:12pt;"><span style="line-height:115%;">Obstetric trauma patients without adverse outcomes</span></span></li><li style="list-style-position:inside;margin-bottom:11px;"><span style="font-size:12pt;"><span style="line-height:115%;">Pregnant individuals without trauma exposure</span></span></li></ol></li><li style="list-style-position:inside;margin-bottom:11px;"><span style="font-size:12pt;"><span style="line-height:115%;">To identify predictive factors for adverse maternal and foetal outcomes following trauma using co-variate analysis.</span></span></li></ol><div style="list-style-position:inside;margin-bottom:11px;"><p style="margin: 0;"><span style="font-size:12pt;"><span style="line-height:normal;"><strong>Study population:</strong></span></span><br><span style="font-size:12pt;"><span style="line-height:115%;">For objective 1 – will include all individuals who have experienced trauma during their pregnancy during the study period and have had their delivery in Barts Health in the database during the study period (1st Jan 2012 to last date of data availability). Individuals will enter the cohort once pregnancy is coded and exit six weeks post-delivery. Women with multiple pregnancies can re-enter the cohort during each subsequent pregnancy</span></span><br><span style="font-size:12pt;"><span style="line-height:115%;">For objective 2 &amp; 3 – three different groups of pregnant individuals will be characterised separately and compared in the study period (1st Jan 2012 to the last date of data availability):</span></span></p><ul style="list-style-position: inside; margin-bottom: 11px;"><li style="list-style-position:inside;margin-bottom:11px;"><span style="font-size:12pt;"><span style="line-height:115%;">Group 1: Trauma with adverse maternal or foetal outcomes</span></span><ul style="list-style-position: inside;"><li style="list-style-position:inside;margin-bottom:11px;"><span style="font-size:12pt;"><span style="line-height:115%;">at least 1 coded injury or external causation</span></span></li><li style="list-style-position:inside;margin-bottom:11px;"><span style="font-size:12pt;"><span style="line-height:115%;">at least 1 coded maternal or foetal adverse outcome</span></span></li></ul></li><li style="list-style-position:inside;margin-bottom:11px;"><span style="font-size:12pt;"><span style="line-height:115%;">Group 2: Trauma without adverse maternal or foetal outcomes</span></span><ul style="list-style-position: inside;"><li style="list-style-position:inside;margin-bottom:11px;"><span style="font-size:12pt;"><span style="line-height:115%;">at least 1 coded injury or external causation</span></span></li><li style="list-style-position:inside;margin-bottom:11px;"><span style="font-size:12pt;"><span style="line-height:115%;">at most 0 coded maternal or foetal adverse outcomes</span></span></li></ul></li><li style="list-style-position:inside;margin-bottom:11px;"><span style="font-size:12pt;"><span style="line-height:115%;">Group 3: No trauma during pregnancy</span></span><ul style="list-style-position: inside;"><li style="list-style-position:inside;margin-bottom:11px;"><span style="font-size:12pt;"><span style="line-height:115%;">at most 0 coded injury or external causation</span></span></li></ul></li></ul></div></div></div>

Requested Data Summary

<div data-wrapper="true" style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt"><div><div><div><span style="font-size:12pt"><strong><span style="font-family:Aptos,sans-serif">Exposure variables</span></strong></span></div><div><ul style="margin-bottom:11px">	<li style="margin-bottom:11px; margin-left:8px;list-style-position:inside"><span style="font-size:12pt"><span style="line-height:115%"><span style="font-family:Calibri,sans-serif"><span style="line-height:115%"><span style="font-family:&quot;Aptos&quot;,sans-serif">A traumatic exposure will be defined as having either of the following criteria: </span></span></span></span></span>	<ul style="list-style-type:circle">		<li style="margin-bottom:11px; margin-left:8px; list-style-position:inside"><span style="font-size:12pt"><span style="line-height:115%"><span style="font-family:Calibri,sans-serif"><span style="line-height:115%"><span style="font-family:&quot;Aptos&quot;,sans-serif">a coded injury: Fractures/dislocations/sprains/strains, intracranial injuries; internal injuries to thorax; abdomen and pelvis; open wounds; injury to blood vessels; superficial injuries/contusions/crushing injuries; burns, and nerve and spinal cord injuries</span></span></span></span></span></li>		<li style="margin-bottom:11px; margin-left:8px; list-style-position:inside"><span style="font-size:12pt"><span style="line-height:115%"><span style="font-family:Calibri,sans-serif"><span style="line-height:115%"><span style="font-family:&quot;Aptos&quot;,sans-serif">a coded external causation codes motor vehicle accidents, falls, drowning, suicide attempts, assaults, fires and use of guns </span></span></span></span></span></li>	</ul>	</li></ul><span style="font-size:12pt"><strong><span style="line-height:115%"><span style="font-family:Calibri,sans-serif"><span style="line-height:115%"><span style="font-family:&quot;Aptos&quot;,sans-serif">Outcomes measures</span></span></span></span></strong></span><ul style="margin-bottom:11px">	<li style="margin-bottom:11px;list-style-position:inside"><span style="font-size:12pt"><span style="line-height:115%"><span style="font-family:Calibri,sans-serif"><span style="line-height:115%"><span style="font-family:&quot;Aptos&quot;,sans-serif">Maternal adverse outcomes at delivery: </span></span></span></span></span>	<ul style="list-style-type:circle">		<li style="margin-bottom:11px;list-style-position:inside"><span style="font-size:12pt"><span style="line-height:115%"><span style="font-family:Calibri,sans-serif"><span style="line-height:115%"><span style="font-family:&quot;Aptos&quot;,sans-serif">preterm labour, premature rupture of membranes, placental abruption, caesarean hysterectomy, uterine rupture before and during labour, blood transfusion, caesarean section (with indication foetal distress, maternal distress, or both), and maternal death, resuscitation required or peri-mortem section</span></span></span></span></span></li>	</ul>	</li>	<li style="margin-bottom:11px;list-style-position:inside"><span style="font-size:12pt"><span style="line-height:115%"><span style="font-family:Calibri,sans-serif"><span style="line-height:115%"><span style="font-family:&quot;Aptos&quot;,sans-serif">Maternal adverse outcomes at 42 days</span></span></span></span></span>	<ul style="list-style-type:circle">		<li style="margin-bottom:11px;list-style-position:inside"><span style="font-size:12pt"><span style="line-height:115%"><span style="font-family:Calibri,sans-serif"><span style="line-height:115%"><span style="font-family:&quot;Aptos&quot;,sans-serif">&nbsp;VTE (DVT or PE)</span></span></span></span></span></li>		<li style="margin-bottom:11px;list-style-position:inside"><span style="font-size:12pt"><span style="line-height:115%"><span style="font-family:Calibri,sans-serif"><span style="line-height:115%"><span style="font-family:&quot;Aptos&quot;,sans-serif">Wound infection</span></span></span></span></span></li>	</ul>	</li>	<li style="margin-bottom:11px;list-style-position:inside"><span style="font-size:12pt"><span style="line-height:115%"><span style="font-family:Calibri,sans-serif"><span style="line-height:115%"><span style="font-family:&quot;Aptos&quot;,sans-serif">Foetal adverse outcomes: </span></span></span></span></span>	<ul style="list-style-type:circle">		<li style="margin-bottom:11px;list-style-position:inside"><span style="font-size:12pt"><span style="line-height:115%"><span style="font-family:Calibri,sans-serif"><span style="line-height:115%"><span style="font-family:&quot;Aptos&quot;,sans-serif">premature delivery (before 37 weeks), low birth weight (under 2500 g), foetal distress, birth asphyxia, respiratory distress syndrome, foetal, neonatal, and infant death.</span></span></span></span></span></li>	</ul>	</li></ul><span style="font-size:12pt"><strong><span style="line-height:115%"><span style="font-family:Calibri,sans-serif"><span style="line-height:115%"><span style="font-family:&quot;Aptos&quot;,sans-serif">Other variables</span></span></span></span></strong></span><ul style="margin-bottom:11px">	<li style="margin-bottom:11px;list-style-position:inside"><span style="font-size:12pt"><span style="line-height:115%"><span style="font-family:Calibri,sans-serif"><span style="line-height:115%"><span style="font-family:&quot;Aptos&quot;,sans-serif">Patient demographic data: </span></span></span></span></span>	<ul style="list-style-type:circle">		<li style="margin-bottom:11px;list-style-position:inside"><span style="font-size:12pt"><span style="line-height:115%"><span style="font-family:Calibri,sans-serif"><span style="line-height:115%"><span style="font-family:&quot;Aptos&quot;,sans-serif">Basic patient demographic: (Maternal age, ethnicity, gestational stage by dates or US, parity, education and treating hospital)</span></span></span></span></span></li>		<li style="margin-bottom:11px;list-style-position:inside"><span style="font-size:12pt"><span style="line-height:115%"><span style="font-family:Calibri,sans-serif"><span style="line-height:115%"><span style="font-family:&quot;Aptos&quot;,sans-serif">Comorbidity </span></span></span></span></span></li>		<li style="margin-bottom:11px;list-style-position:inside"><span style="font-size:12pt"><span style="line-height:115%"><span style="font-family:Calibri,sans-serif"><span style="line-height:115%"><span style="font-family:&quot;Aptos&quot;,sans-serif">Medications received including Tranexamic acid, Low Molecular Weight Heparin&nbsp;and analgesia post-partum.</span></span></span></span></span></li>	</ul>	</li>	<li style="margin-bottom:11px;list-style-position:inside"><span style="font-size:12pt"><span style="line-height:115%"><span style="font-family:Calibri,sans-serif"><span style="line-height:115%"><span style="font-family:&quot;Aptos&quot;,sans-serif">Post-traumatic signs, symptoms and investigation results:&nbsp; </span></span></span></span></span>	<ul style="list-style-type:circle">		<li style="margin-bottom:11px;list-style-position:inside"><span style="font-size:12pt"><span style="line-height:115%"><span style="font-family:Calibri,sans-serif"><span style="line-height:115%"><span style="font-family:&quot;Aptos&quot;,sans-serif">vaginal bleeding, abdominal pain, maternal hypotension</span></span></span></span></span></li>		<li style="margin-bottom:11px;list-style-position:inside"><span style="font-size:12pt"><span style="line-height:115%"><span style="font-family:Calibri,sans-serif"><span style="line-height:115%"><span style="font-family:&quot;Aptos&quot;,sans-serif">Investigation result: Fast scan result; CTG or foetal doppler result (uterine activity, abnormal foetal tracing (bradycardia, deceleration, or lack of foetal heart tones); Fibrinogen levels &lt;200 g/dL; VBG results: Lactate, pCO2, pH, bicarbonate; Kleihauer-Betke tests; MRI and CT results</span></span></span></span></span></li>	</ul>	</li></ul></div></div></div></div>

Technical Description

<div data-wrapper="true" style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt"><div><span style="font-family:Arial,Helvetica,sans-serif"><span style="font-size:12pt"><span style="line-height:115%">All data analysis will be carried out in a secure data environment using internal system including the Barts Health researchers’ system and only mentioned BH employee will have access to the data.<br><br><strong>For objective 1:</strong><br>To provide a general description of the data captured, the incidence of trauma in pregnancy, proportion of different trauma mechanisms, injury types, injury severity and patient demographics will be described and summarised in a table (N, %)<strong><span style="line-height:115%">. </span></strong>Plausibility checks will be conducted in addition to a summary of missingness in OMOP CDM fields.</span><br><br><br><span style="line-height:115%"><strong>For objective 2:</strong></span><br><span style="line-height:115%">To characterise the 3 different groups separately, the incidents of adverse outcomes across each group will be presented with either mean and standard deviation or median and interquartile range depending on the distribution normality assessed by the Kolmogorov-Smirnov test.</span></span></span></div><div><br><span style="font-family:Arial,Helvetica,sans-serif"><span style="font-size:12pt"><span style="line-height:115%"><strong>For objective 3:</strong></span><br><span style="line-height:115%">Predictive factors for adverse maternal and foetal outcomes will be identified and if appropriate will undertake regression analysis</span></span></span></div><div><br><span style="font-family:Arial,Helvetica,sans-serif"><span style="font-size:12pt"><span style="line-height:115%"><span style="color:black">Open-source code will be used where feasible, the analysis code will be shared via github.</span></span></span></span></div></div>

Public and Patient Involvement and Engagement Summary

<div data-wrapper="true" style="font-family:'Segoe UI','Helvetica Neue',sans-serif; font-size:9pt"><div><span style="font-size:12pt"><span style="line-height:normal"><span style="font-family:Aptos,sans-serif">This study will be discussed with the Bone and Joint Health PPIE group to ensure that the design is refined to incorporate their suggestions, and particularly in their ideas for dissemination and communication to the local community. We are working closely with obstetric and trauma clinicians at Barts Health to identify the best way to conduct the study, in addition to identifying how the results could be used locally to improve patient care depending on findings.</span></span></span></div></div>

Reporting

<div class="ck-content" data-wrapper="true" dir="ltr" style="--ck-image-style-spacing: 1.5em; --ck-inline-image-style-spacing: calc(var(--ck-image-style-spacing) / 2); font-family: 'Segoe UI','Helvetica Neue',sans-serif; font-size: 9pt;"><p style="margin: 0;"><span style="font-size:12pt;"><span style="line-height:115%;">All data are anonymised. No personal identifiers will be reported. Cells with fewer than five individuals will be reported as "&lt;5" per national information governance standards as a risk mitigation strategy to minimise the risk of patient identification.</span></span><br><br><span style="background-color:white;color:black;font-size:12pt;"><span style="line-height:115%;">All findings will be submitted to scientific conferences and/or published as manuscripts in scientific journals. Codes and results will be made publicly available in GitHub and by means of Shiny apps.&nbsp;The codes will be open source and reproducible.</span></span></p><p style="margin: 0;"><br><span style="color:black;font-size:12pt;"><span style="line-height:115%;">Intend to publicise and disseminate methods and findings through publication in peer-reviewed journals.</span></span></p></div>

Contact Points

Project Lead Name

Project Lead Position

Project Lead Email

Lead Organisation Name

Lead Organisation Address

The Royal London Hospital, Whitechapel Road, E1 1BB

Secure Data Environment (SDE)

Will you be using the BH SDE

NoYes

Details of the location and IT system (the SDE) where the data extract will be kept and processed.