Study of How Adiposity in Pregnancy has an Effect on outcomeS (SHAPES): protocol for a prospective cohort study
Introduction Maternal obesity increases the risk of multiple maternal and infant pregnancy complications, such as gestational diabetes and pre-eclampsia. Current UK guidelines use body mass index (BMI) to identify which women require additional care due to increased risk of complications. However, B...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/9/e073545.full |
| _version_ | 1827802734742470656 |
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| author | Louise Hayes Luke Vale Dawn Teare John Allotey Nicola Heslehurst Theophile Bigirumurame Raya Vinogradov Giang T Nguyen Susan C Lennie Victoria Murtha Rebecca Tothill Janine Smith |
| author_facet | Louise Hayes Luke Vale Dawn Teare John Allotey Nicola Heslehurst Theophile Bigirumurame Raya Vinogradov Giang T Nguyen Susan C Lennie Victoria Murtha Rebecca Tothill Janine Smith |
| author_sort | Louise Hayes |
| collection | DOAJ |
| description | Introduction Maternal obesity increases the risk of multiple maternal and infant pregnancy complications, such as gestational diabetes and pre-eclampsia. Current UK guidelines use body mass index (BMI) to identify which women require additional care due to increased risk of complications. However, BMI may not accurately predict which women will develop complications during pregnancy as it does not determine amount and distribution of adipose tissue. Some adiposity measures (eg, waist circumference, ultrasound measures of abdominal visceral fat) can better identify where body fat is stored, which may be useful in predicting those women who need additional care.Methods and analysis This prospective cohort study (SHAPES, Study of How Adiposity in Pregnancy has an Effect on outcomeS) aims to evaluate the prognostic performance of adiposity measures (either alone or in combination with other adiposity, sociodemographic or clinical measures) to estimate risk of adverse pregnancy outcomes. Pregnant women (n=1400) will be recruited at their first trimester ultrasound scan (11+2–14+1 weeks’) at Newcastle upon Tyne National Health Service Foundation Trust, UK. Early pregnancy adiposity measures and clinical and sociodemographic data will be collected. Routine data on maternal and infant pregnancy outcomes will be collected from routine hospital records. Regression methods will be used to compare the different adiposity measures with BMI in terms of their ability to predict pregnancy complications. If no individual measure performs better than BMI, multivariable models will be developed and evaluated to identify the most parsimonious model. The apparent performance of the developed model will be summarised using calibration, discrimination and internal validation analyses.Ethics and dissemination Ethical favourable opinion has been obtained from the North East: Newcastle & North Tyneside 1 Research Ethics Committee (REC reference: 22/NE/0035). All participants provide informed consent to take part in SHAPES. Planned dissemination includes peer-reviewed publications and additional dissemination appropriate to target audiences, including policy briefs for policymakers, media/social-media coverage for public and conferences for researchTrial registration number ISRCTN82185177. |
| first_indexed | 2024-03-11T20:43:22Z |
| format | Article |
| id | doaj.art-56ef05f78c804680826f1954a48aedf6 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-11T20:43:22Z |
| publishDate | 2023-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-56ef05f78c804680826f1954a48aedf62023-10-01T22:55:08ZengBMJ Publishing GroupBMJ Open2044-60552023-09-0113910.1136/bmjopen-2023-073545Study of How Adiposity in Pregnancy has an Effect on outcomeS (SHAPES): protocol for a prospective cohort studyLouise Hayes0Luke Vale1Dawn Teare2John Allotey3Nicola Heslehurst4Theophile Bigirumurame5Raya Vinogradov6Giang T Nguyen7Susan C Lennie8Victoria Murtha9Rebecca Tothill10Janine Smith11Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UKPopulation Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UKPopulation Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UKInstitute of Metabolism and Systems Research, University of Birmingham, Birmingham, UKPopulation Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UKPopulation Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UKPopulation Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UKPopulation Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UKPopulation Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UKMaternity Services, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UKMaternity Services, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UKJanine Smith Practice, Newcastle upon Tyne, Tyneside, UKIntroduction Maternal obesity increases the risk of multiple maternal and infant pregnancy complications, such as gestational diabetes and pre-eclampsia. Current UK guidelines use body mass index (BMI) to identify which women require additional care due to increased risk of complications. However, BMI may not accurately predict which women will develop complications during pregnancy as it does not determine amount and distribution of adipose tissue. Some adiposity measures (eg, waist circumference, ultrasound measures of abdominal visceral fat) can better identify where body fat is stored, which may be useful in predicting those women who need additional care.Methods and analysis This prospective cohort study (SHAPES, Study of How Adiposity in Pregnancy has an Effect on outcomeS) aims to evaluate the prognostic performance of adiposity measures (either alone or in combination with other adiposity, sociodemographic or clinical measures) to estimate risk of adverse pregnancy outcomes. Pregnant women (n=1400) will be recruited at their first trimester ultrasound scan (11+2–14+1 weeks’) at Newcastle upon Tyne National Health Service Foundation Trust, UK. Early pregnancy adiposity measures and clinical and sociodemographic data will be collected. Routine data on maternal and infant pregnancy outcomes will be collected from routine hospital records. Regression methods will be used to compare the different adiposity measures with BMI in terms of their ability to predict pregnancy complications. If no individual measure performs better than BMI, multivariable models will be developed and evaluated to identify the most parsimonious model. The apparent performance of the developed model will be summarised using calibration, discrimination and internal validation analyses.Ethics and dissemination Ethical favourable opinion has been obtained from the North East: Newcastle & North Tyneside 1 Research Ethics Committee (REC reference: 22/NE/0035). All participants provide informed consent to take part in SHAPES. Planned dissemination includes peer-reviewed publications and additional dissemination appropriate to target audiences, including policy briefs for policymakers, media/social-media coverage for public and conferences for researchTrial registration number ISRCTN82185177.https://bmjopen.bmj.com/content/13/9/e073545.full |
| spellingShingle | Louise Hayes Luke Vale Dawn Teare John Allotey Nicola Heslehurst Theophile Bigirumurame Raya Vinogradov Giang T Nguyen Susan C Lennie Victoria Murtha Rebecca Tothill Janine Smith Study of How Adiposity in Pregnancy has an Effect on outcomeS (SHAPES): protocol for a prospective cohort study BMJ Open |
| title | Study of How Adiposity in Pregnancy has an Effect on outcomeS (SHAPES): protocol for a prospective cohort study |
| title_full | Study of How Adiposity in Pregnancy has an Effect on outcomeS (SHAPES): protocol for a prospective cohort study |
| title_fullStr | Study of How Adiposity in Pregnancy has an Effect on outcomeS (SHAPES): protocol for a prospective cohort study |
| title_full_unstemmed | Study of How Adiposity in Pregnancy has an Effect on outcomeS (SHAPES): protocol for a prospective cohort study |
| title_short | Study of How Adiposity in Pregnancy has an Effect on outcomeS (SHAPES): protocol for a prospective cohort study |
| title_sort | study of how adiposity in pregnancy has an effect on outcomes shapes protocol for a prospective cohort study |
| url | https://bmjopen.bmj.com/content/13/9/e073545.full |
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