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1. Additional file 9 of Polypharmacy during pregnancy and associated risk factors: a retrospective analysis of 577 medication exposures among 1.5 million pregnancies in the UK, 2000-2019

Author

Subramanian, Anuradhaa, Azcoaga-Lorenzo, Amaya, Anand, Astha, Phillips, Katherine, Lee, Siang Ing, Cockburn, Neil, Fagbamigbe, Adeniyi Francis, Damase-Michel, Christine, Yau, Christopher, McCowan, Colin, O’Reilly, Dermot, Santorelli, Gillian, Hope, Holly, Kennedy, Jonathan I., Abel, Kathryn M., Eastwood, Kelly-Ann, Locock, Louise, Black, Mairead, Loane, Maria, Moss, Ngawai, Plachcinski, Rachel, Thangaratinam, Shakila, Brophy, Sinead, Agrawal, Utkarsh, Vowles, Zoe, Brocklehurst, Peter, Dolk, Helen, Nelson-Piercy, Catherine, and Nirantharakumar, Krishnarajah

Abstract

Additional file 9: Figure S5. Risk factors associated with polypharmacy during the entire pregnancy period.

Published
2023
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2. Additional file 3 of Polypharmacy during pregnancy and associated risk factors: a retrospective analysis of 577 medication exposures among 1.5 million pregnancies in the UK, 2000-2019

Author

Subramanian, Anuradhaa, Azcoaga-Lorenzo, Amaya, Anand, Astha, Phillips, Katherine, Lee, Siang Ing, Cockburn, Neil, Fagbamigbe, Adeniyi Francis, Damase-Michel, Christine, Yau, Christopher, McCowan, Colin, O’Reilly, Dermot, Santorelli, Gillian, Hope, Holly, Kennedy, Jonathan I., Abel, Kathryn M., Eastwood, Kelly-Ann, Locock, Louise, Black, Mairead, Loane, Maria, Moss, Ngawai, Plachcinski, Rachel, Thangaratinam, Shakila, Brophy, Sinead, Agrawal, Utkarsh, Vowles, Zoe, Brocklehurst, Peter, Dolk, Helen, Nelson-Piercy, Catherine, and Nirantharakumar, Krishnarajah

Abstract

Additional file 3: Figure S3. Polypharmacy (5 or more medications) prevalence trend from 2000 to 2019.

Published
2023
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3. Additional file 8 of Polypharmacy during pregnancy and associated risk factors: a retrospective analysis of 577 medication exposures among 1.5 million pregnancies in the UK, 2000-2019

Author

Subramanian, Anuradhaa, Azcoaga-Lorenzo, Amaya, Anand, Astha, Phillips, Katherine, Lee, Siang Ing, Cockburn, Neil, Fagbamigbe, Adeniyi Francis, Damase-Michel, Christine, Yau, Christopher, McCowan, Colin, O’Reilly, Dermot, Santorelli, Gillian, Hope, Holly, Kennedy, Jonathan I., Abel, Kathryn M., Eastwood, Kelly-Ann, Locock, Louise, Black, Mairead, Loane, Maria, Moss, Ngawai, Plachcinski, Rachel, Thangaratinam, Shakila, Brophy, Sinead, Agrawal, Utkarsh, Vowles, Zoe, Brocklehurst, Peter, Dolk, Helen, Nelson-Piercy, Catherine, and Nirantharakumar, Krishnarajah

Abstract

Additional file 8: Figure S4. Risk factors associated with polypharmacy during the first trimester of pregnancy.

Published
2023
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4. Additional file 1 of Polypharmacy during pregnancy and associated risk factors: a retrospective analysis of 577 medication exposures among 1.5 million pregnancies in the UK, 2000-2019

Author

Subramanian, Anuradhaa, Azcoaga-Lorenzo, Amaya, Anand, Astha, Phillips, Katherine, Lee, Siang Ing, Cockburn, Neil, Fagbamigbe, Adeniyi Francis, Damase-Michel, Christine, Yau, Christopher, McCowan, Colin, O’Reilly, Dermot, Santorelli, Gillian, Hope, Holly, Kennedy, Jonathan I., Abel, Kathryn M., Eastwood, Kelly-Ann, Locock, Louise, Black, Mairead, Loane, Maria, Moss, Ngawai, Plachcinski, Rachel, Thangaratinam, Shakila, Brophy, Sinead, Agrawal, Utkarsh, Vowles, Zoe, Brocklehurst, Peter, Dolk, Helen, Nelson-Piercy, Catherine, and Nirantharakumar, Krishnarajah

Abstract

Additional file 1: Figure S1. Flow diagram showing the selection of eligible pregnancies from the CPRD pregnancy register.

Published
2023
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5. Additional file 2 of Epidemiology of pre-existing multimorbidity in pregnant women in the UK in 2018: a population-based cross-sectional study

Author

Lee, Siang Ing, Azcoaga-Lorenzo, Amaya, Agrawal, Utkarsh, Kennedy, Jonathan I., Fagbamigbe, Adeniyi Francis, Hope, Holly, Subramanian, Anuradhaa, Anand, Astha, Taylor, Beck, Nelson-Piercy, Catherine, Damase-Michel, Christine, Yau, Christopher, Crowe, Francesca, Santorelli, Gillian, Eastwood, Kelly-Ann, Vowles, Zoe, Loane, Maria, Moss, Ngawai, Brocklehurst, Peter, Plachcinski, Rachel, Thangaratinam, Shakila, Black, Mairead, O���Reilly, Dermot, Abel, Kathryn M., Brophy, Sinead, Nirantharakumar, Krishnarajah, and McCowan, Colin

Abstract

Additional file 2. Read codes and International Classification of Disease-version 10 (ICD-10) codes for health conditions.

Published
2022
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6. Additional file 5 of Epidemiology of pre-existing multimorbidity in pregnant women in the UK in 2018: a population-based cross-sectional study

Author

Lee, Siang Ing, Azcoaga-Lorenzo, Amaya, Agrawal, Utkarsh, Kennedy, Jonathan I., Fagbamigbe, Adeniyi Francis, Hope, Holly, Subramanian, Anuradhaa, Anand, Astha, Taylor, Beck, Nelson-Piercy, Catherine, Damase-Michel, Christine, Yau, Christopher, Crowe, Francesca, Santorelli, Gillian, Eastwood, Kelly-Ann, Vowles, Zoe, Loane, Maria, Moss, Ngawai, Brocklehurst, Peter, Plachcinski, Rachel, Thangaratinam, Shakila, Black, Mairead, O���Reilly, Dermot, Abel, Kathryn M., Brophy, Sinead, Nirantharakumar, Krishnarajah, and McCowan, Colin

Abstract

Additional file 5. Limitations of CPRD, SAIL, SMR.

Published
2022
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7. Additional file 12 of Epidemiology of pre-existing multimorbidity in pregnant women in the UK in 2018: a population-based cross-sectional study

Author

Lee, Siang Ing, Azcoaga-Lorenzo, Amaya, Agrawal, Utkarsh, Kennedy, Jonathan I., Fagbamigbe, Adeniyi Francis, Hope, Holly, Subramanian, Anuradhaa, Anand, Astha, Taylor, Beck, Nelson-Piercy, Catherine, Damase-Michel, Christine, Yau, Christopher, Crowe, Francesca, Santorelli, Gillian, Eastwood, Kelly-Ann, Vowles, Zoe, Loane, Maria, Moss, Ngawai, Brocklehurst, Peter, Plachcinski, Rachel, Thangaratinam, Shakila, Black, Mairead, O���Reilly, Dermot, Abel, Kathryn M., Brophy, Sinead, Nirantharakumar, Krishnarajah, and McCowan, Colin

Abstract

Additional file 12: Table 6. Post hoc logistic regression removing conditions that were associated with less deprived IMD quintiles in CPRD England study cohort (n = 13,075).

Published
2022
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8. Additional file 8 of Epidemiology of pre-existing multimorbidity in pregnant women in the UK in 2018: a population-based cross-sectional study

Author

Lee, Siang Ing, Azcoaga-Lorenzo, Amaya, Agrawal, Utkarsh, Kennedy, Jonathan I., Fagbamigbe, Adeniyi Francis, Hope, Holly, Subramanian, Anuradhaa, Anand, Astha, Taylor, Beck, Nelson-Piercy, Catherine, Damase-Michel, Christine, Yau, Christopher, Crowe, Francesca, Santorelli, Gillian, Eastwood, Kelly-Ann, Vowles, Zoe, Loane, Maria, Moss, Ngawai, Brocklehurst, Peter, Plachcinski, Rachel, Thangaratinam, Shakila, Black, Mairead, O���Reilly, Dermot, Abel, Kathryn M., Brophy, Sinead, Nirantharakumar, Krishnarajah, and McCowan, Colin

Abstract

Additional file 8: Table 2. Percentage of pregnant women by the total morbidity count in CPRD, SAIL, SMR in 2018.

Published
2022
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9. Additional file 13 of Epidemiology of pre-existing multimorbidity in pregnant women in the UK in 2018: a population-based cross-sectional study

Author

Lee, Siang Ing, Azcoaga-Lorenzo, Amaya, Agrawal, Utkarsh, Kennedy, Jonathan I., Fagbamigbe, Adeniyi Francis, Hope, Holly, Subramanian, Anuradhaa, Anand, Astha, Taylor, Beck, Nelson-Piercy, Catherine, Damase-Michel, Christine, Yau, Christopher, Crowe, Francesca, Santorelli, Gillian, Eastwood, Kelly-Ann, Vowles, Zoe, Loane, Maria, Moss, Ngawai, Brocklehurst, Peter, Plachcinski, Rachel, Thangaratinam, Shakila, Black, Mairead, O���Reilly, Dermot, Abel, Kathryn M., Brophy, Sinead, Nirantharakumar, Krishnarajah, and McCowan, Colin

Abstract

Additional file 13: Table 7. Prevalence of individual health conditions in pregnant women aged 15���49 years in CPRD, SAIL, SMR in 2018.

Published
2022
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10. Additional file 7 of Epidemiology of pre-existing multimorbidity in pregnant women in the UK in 2018: a population-based cross-sectional study

Author

Lee, Siang Ing, Azcoaga-Lorenzo, Amaya, Agrawal, Utkarsh, Kennedy, Jonathan I., Fagbamigbe, Adeniyi Francis, Hope, Holly, Subramanian, Anuradhaa, Anand, Astha, Taylor, Beck, Nelson-Piercy, Catherine, Damase-Michel, Christine, Yau, Christopher, Crowe, Francesca, Santorelli, Gillian, Eastwood, Kelly-Ann, Vowles, Zoe, Loane, Maria, Moss, Ngawai, Brocklehurst, Peter, Plachcinski, Rachel, Thangaratinam, Shakila, Black, Mairead, O���Reilly, Dermot, Abel, Kathryn M., Brophy, Sinead, Nirantharakumar, Krishnarajah, and McCowan, Colin

Abstract

Additional file 7: Table 1. Practice level index of multiple deprivation (IMD) quintile by nations in the CPRD 2018 pregnancy cohort.

Published
2022
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11. Additional file 11 of Epidemiology of pre-existing multimorbidity in pregnant women in the UK in 2018: a population-based cross-sectional study

Author

Lee, Siang Ing, Azcoaga-Lorenzo, Amaya, Agrawal, Utkarsh, Kennedy, Jonathan I., Fagbamigbe, Adeniyi Francis, Hope, Holly, Subramanian, Anuradhaa, Anand, Astha, Taylor, Beck, Nelson-Piercy, Catherine, Damase-Michel, Christine, Yau, Christopher, Crowe, Francesca, Santorelli, Gillian, Eastwood, Kelly-Ann, Vowles, Zoe, Loane, Maria, Moss, Ngawai, Brocklehurst, Peter, Plachcinski, Rachel, Thangaratinam, Shakila, Black, Mairead, O���Reilly, Dermot, Abel, Kathryn M., Brophy, Sinead, Nirantharakumar, Krishnarajah, and McCowan, Colin

Abstract

Additional file 11: Table 5. Post hoc logistic regression with multimorbidity defined using list of 31 conditions from Barnet et al���s paper.

Published
2022
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12. sj-doc-2-tab-10.1177_1759720X221087650 – Supplemental material for Pharmacovigilance pregnancy data in a large population of patients with chronic inflammatory disease exposed to certolizumab pegol

Author

Clowse, Megan, Fischer-Betz, Rebecca, Nelson-Piercy, Catherine, Scheuerle, Angela E., Stephan, Brigitte, Dubinsky, Marla, Kumke, Thomas, Kasliwal, Rachna, Lauwerys, Bernard, and Förger, Frauke

Subjects
FOS: Clinical medicine, 110604 Sports Medicine, FOS: Health sciences, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, 110314 Orthopaedics
Abstract

Supplemental material, sj-doc-2-tab-10.1177_1759720X221087650 for Pharmacovigilance pregnancy data in a large population of patients with chronic inflammatory disease exposed to certolizumab pegol by Megan Clowse, Rebecca Fischer-Betz, Catherine Nelson-Piercy, Angela E. Scheuerle, Brigitte Stephan, Marla Dubinsky, Thomas Kumke, Rachna Kasliwal, Bernard Lauwerys and Frauke Förger in Therapeutic Advances in Musculoskeletal Disease

Published
2022
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13. Additional file 9 of Epidemiology of pre-existing multimorbidity in pregnant women in the UK in 2018: a population-based cross-sectional study

Author

Lee, Siang Ing, Azcoaga-Lorenzo, Amaya, Agrawal, Utkarsh, Kennedy, Jonathan I., Fagbamigbe, Adeniyi Francis, Hope, Holly, Subramanian, Anuradhaa, Anand, Astha, Taylor, Beck, Nelson-Piercy, Catherine, Damase-Michel, Christine, Yau, Christopher, Crowe, Francesca, Santorelli, Gillian, Eastwood, Kelly-Ann, Vowles, Zoe, Loane, Maria, Moss, Ngawai, Brocklehurst, Peter, Plachcinski, Rachel, Thangaratinam, Shakila, Black, Mairead, O���Reilly, Dermot, Abel, Kathryn M., Brophy, Sinead, Nirantharakumar, Krishnarajah, and McCowan, Colin

Abstract

Additional file 9: Table 3. Prevalence of pre-existing multimorbidity in pregnant women in CPRD, SAIL, SMR in 2018 by women���s characteristics.

Published
2022
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14. Additional file 4 of Epidemiology of pre-existing multimorbidity in pregnant women in the UK in 2018: a population-based cross-sectional study

Author

Lee, Siang Ing, Azcoaga-Lorenzo, Amaya, Agrawal, Utkarsh, Kennedy, Jonathan I., Fagbamigbe, Adeniyi Francis, Hope, Holly, Subramanian, Anuradhaa, Anand, Astha, Taylor, Beck, Nelson-Piercy, Catherine, Damase-Michel, Christine, Yau, Christopher, Crowe, Francesca, Santorelli, Gillian, Eastwood, Kelly-Ann, Vowles, Zoe, Loane, Maria, Moss, Ngawai, Brocklehurst, Peter, Plachcinski, Rachel, Thangaratinam, Shakila, Black, Mairead, O���Reilly, Dermot, Abel, Kathryn M., Brophy, Sinead, Nirantharakumar, Krishnarajah, and McCowan, Colin

Abstract

Additional file 4. The RECORD statement.

Published
2022
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15. Additional file 10 of Epidemiology of pre-existing multimorbidity in pregnant women in the UK in 2018: a population-based cross-sectional study

Author

Lee, Siang Ing, Azcoaga-Lorenzo, Amaya, Agrawal, Utkarsh, Kennedy, Jonathan I., Fagbamigbe, Adeniyi Francis, Hope, Holly, Subramanian, Anuradhaa, Anand, Astha, Taylor, Beck, Nelson-Piercy, Catherine, Damase-Michel, Christine, Yau, Christopher, Crowe, Francesca, Santorelli, Gillian, Eastwood, Kelly-Ann, Vowles, Zoe, Loane, Maria, Moss, Ngawai, Brocklehurst, Peter, Plachcinski, Rachel, Thangaratinam, Shakila, Black, Mairead, O���Reilly, Dermot, Abel, Kathryn M., Brophy, Sinead, Nirantharakumar, Krishnarajah, and McCowan, Colin

Abstract

Additional file 10: Table 4. Sensitivity analysis of CPRD England study cohort (n = 13,075) with imputed ethnicity and deprivation data.

Published
2022
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16. sj-docx-1-tab-10.1177_1759720X221087650 – Supplemental material for Pharmacovigilance pregnancy data in a large population of patients with chronic inflammatory disease exposed to certolizumab pegol

Author

Clowse, Megan, Fischer-Betz, Rebecca, Nelson-Piercy, Catherine, Scheuerle, Angela E., Stephan, Brigitte, Dubinsky, Marla, Kumke, Thomas, Kasliwal, Rachna, Lauwerys, Bernard, and Förger, Frauke

Subjects
FOS: Clinical medicine, 110604 Sports Medicine, FOS: Health sciences, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, 110314 Orthopaedics
Abstract

Supplemental material, sj-docx-1-tab-10.1177_1759720X221087650 for Pharmacovigilance pregnancy data in a large population of patients with chronic inflammatory disease exposed to certolizumab pegol by Megan Clowse, Rebecca Fischer-Betz, Catherine Nelson-Piercy, Angela E. Scheuerle, Brigitte Stephan, Marla Dubinsky, Thomas Kumke, Rachna Kasliwal, Bernard Lauwerys and Frauke Förger in Therapeutic Advances in Musculoskeletal Disease

Published
2022
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17. sj-docx-1-tab-10.1177_1759720X221087650 – Supplemental material for Pharmacovigilance pregnancy data in a large population of patients with chronic inflammatory disease exposed to certolizumab pegol

Author

Clowse, Megan, Fischer-Betz, Rebecca, Nelson-Piercy, Catherine, Scheuerle, Angela E., Stephan, Brigitte, Dubinsky, Marla, Kumke, Thomas, Kasliwal, Rachna, Lauwerys, Bernard, and Förger, Frauke

Subjects
FOS: Clinical medicine, 110604 Sports Medicine, FOS: Health sciences, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified, 110314 Orthopaedics
Abstract

Supplemental material, sj-docx-1-tab-10.1177_1759720X221087650 for Pharmacovigilance pregnancy data in a large population of patients with chronic inflammatory disease exposed to certolizumab pegol by Megan Clowse, Rebecca Fischer-Betz, Catherine Nelson-Piercy, Angela E. Scheuerle, Brigitte Stephan, Marla Dubinsky, Thomas Kumke, Rachna Kasliwal, Bernard Lauwerys and Frauke Förger in Therapeutic Advances in Musculoskeletal Disease

Published
2022
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18. Additional file 3 of Epidemiology of pre-existing multimorbidity in pregnant women in the UK in 2018: a population-based cross-sectional study

Author

Lee, Siang Ing, Azcoaga-Lorenzo, Amaya, Agrawal, Utkarsh, Kennedy, Jonathan I., Fagbamigbe, Adeniyi Francis, Hope, Holly, Subramanian, Anuradhaa, Anand, Astha, Taylor, Beck, Nelson-Piercy, Catherine, Damase-Michel, Christine, Yau, Christopher, Crowe, Francesca, Santorelli, Gillian, Eastwood, Kelly-Ann, Vowles, Zoe, Loane, Maria, Moss, Ngawai, Brocklehurst, Peter, Plachcinski, Rachel, Thangaratinam, Shakila, Black, Mairead, O���Reilly, Dermot, Abel, Kathryn M., Brophy, Sinead, Nirantharakumar, Krishnarajah, and McCowan, Colin

Abstract

Additional file 3. Phenome definitions of health conditions.

Published
2022
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19. Additional file 6 of Epidemiology of pre-existing multimorbidity in pregnant women in the UK in 2018: a population-based cross-sectional study

Author

Lee, Siang Ing, Azcoaga-Lorenzo, Amaya, Agrawal, Utkarsh, Kennedy, Jonathan I., Fagbamigbe, Adeniyi Francis, Hope, Holly, Subramanian, Anuradhaa, Anand, Astha, Taylor, Beck, Nelson-Piercy, Catherine, Damase-Michel, Christine, Yau, Christopher, Crowe, Francesca, Santorelli, Gillian, Eastwood, Kelly-Ann, Vowles, Zoe, Loane, Maria, Moss, Ngawai, Brocklehurst, Peter, Plachcinski, Rachel, Thangaratinam, Shakila, Black, Mairead, O���Reilly, Dermot, Abel, Kathryn M., Brophy, Sinead, Nirantharakumar, Krishnarajah, and McCowan, Colin

Abstract

Additional file 6: Figure 1. Flow chart for selection of study population.

Published
2022
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20. Maternal and child outcomes for pregnant women with pre-existing multiple long-term conditions: protocol for an observational study in the UK

Author

Lee, Sian Ing, Hope, Holly, O'Reilly, Dermot, Kent, Lisa, Santorelli, Gillian, Subramanian, Anuradhaa, Moss, Ngawai, Azcoaga-Lorenzo, Amaya, Fagbamigbe, Adeniyi, Nelson-Piercy, Catherine, Yau, Christopher, McCowan, Colin, Kennedy, Jonathan I, Phillips, Katherine, Singh, Megha, Mhereeg, Mohamed, Cockburn, Neil, Brocklehurst, Peter, Plachcinski, Rachel, Riley, Richard, Thangaratinam, Shakila, Brophy, Sinead, Sudasinghe, Sudasing Pathirannehelage Buddhika Hemali, Agrawal, Utkarsh, Vowles, Zoe, Abel, Kathryn M, Nirantharakumar, Krishnarajah, Black, Mairead, Eastwood, Kelly-Ann, MuM-PreDiCT Group, University of St Andrews. School of Medicine, University of St Andrews. Sir James Mackenzie Institute for Early Diagnosis, and University of St Andrews. Population and Behavioural Science Division

Subjects
Adult, Adolescent, Maternity, OBSTETRICS, Maternal medicine, Young Adult, Offspring, SDG 3 - Good Health and Well-being, Pregnancy, RA0421, RA0421 Public health. Hygiene. Preventive Medicine, Humans, EPIDEMIOLOGY, Child, Children, Outcome, Multiple long-term conditions, MCC, Wales, Mental Disorders, Multimorbidity, Obstetric, 3rd-DAS, General Medicine, Middle Aged, Observational Studies as Topic, Scotland, England, Multiple chronic conditions, RG Gynecology and obstetrics, Female, Pregnant Women, RG
Abstract

Funding: This work is funded by the Strategic Priority Fund 'Tackling multimorbidity at scale' programme (grant number MR/W014432/1) delivered by the Medical Research Council and the National Institute for Health Research (NIHR) in partnership with the Economic and Social Research Council and in collaboration with the Engineering and Physical Sciences Research Council. Introduction One in five pregnant women has multiple pre-existing long-term conditions in the UK. Studies have shown that maternal multiple long-term conditions are associated with adverse outcomes. This observational study aims to compare maternal and child outcomes for pregnant women with multiple long-term conditions to those without multiple long-term conditions (0 or 1 long-term conditions). Methods and analysis Pregnant women aged 15–49 years old with a conception date between 2000 and 2019 in the UK will be included with follow-up till 2019. The data source will be routine health records from all four UK nations (Clinical Practice Research Datalink (England), Secure Anonymised Information Linkage (Wales), Scotland routine health records and Northern Ireland Maternity System) and the Born in Bradford birth cohort. The exposure of two or more pre-existing, long-term physical or mental health conditions will be defined from a list of health conditions predetermined by women and clinicians. The association of maternal multiple long-term conditions with (a) antenatal, (b) peripartum, (c) postnatal and long-term and (d) mental health outcomes, for both women and their children will be examined. Outcomes of interest will be guided by a core outcome set. Comparisons will be made between pregnant women with and without multiple long-term conditions using modified Poisson and Cox regression. Generalised estimating equation will account for the clustering effect of women who had more than one pregnancy episode. Where appropriate, multiple imputation with chained equation will be used for missing data. Federated analysis will be conducted for each dataset and results will be pooled using random-effects meta-analyses. Ethics and dissemination Approval has been obtained from the respective data sources in each UK nation. Study findings will be submitted for publications in peer-reviewed journals and presented at key conferences. Publisher PDF

Published
2023

21. Pharmacovigilance pregnancy data in a large population of patients with chronic inflammatory disease exposed to certolizumab pegol

Author

Clowse, Megan, Fischer-Betz, Rebecca, Nelson-Piercy, Catherine, Scheuerle, Angela E, Stephan, Brigitte, Dubinsky, Marla, Kumke, Thomas, Kasliwal, Rachna, Lauwerys, Bernard, and Förger, Frauke

Subjects
Rheumatology, 610 Medicine & health, Orthopedics and Sports Medicine
Abstract

Introduction: Chronic inflammatory diseases (CIDs), including rheumatic diseases and other inflammatory conditions, often affect women of reproductive age. Tumor necrosis factor inhibitors (TNFi) are widely used to treat CID, but there is limited information on outcomes of TNFi-exposed pregnancies. We evaluated pregnancy outcomes from 1392 prospectively reported pregnancies exposed to certolizumab pegol (CZP), a PEGylated, Fc-free TNFi with no to minimal placental transfer. Methods: CZP-exposed pregnancies in patients with CID from the UCB Pharmacovigilance global safety database were reviewed from the start of CZP clinical development (July 2001) to 1 November 2020. To limit bias, the analysis focused on prospectively reported cases with known pregnancy outcomes. Results: In total, 1392 prospective pregnancies with maternal CZP exposure and known pregnancy outcomes ( n = 1425) were reported; 1021 had at least first-trimester CZP exposure. Live birth was reported in 1259/1425 (88.4%) of all prospective outcomes. There were 150/1425 (10.5%) pregnancy losses before 20 weeks (miscarriage/induced abortion), 11/1425 (0.8%) stillbirths, and 5/1392 (0.4%) ectopic pregnancies. Congenital malformations were present in 30/1259 (2.4%) live-born infants, of which 26 (2.1%) were considered major according to the Metropolitan Atlanta Congenital Defects Program criteria. There was no pattern of congenital malformations. Discussion and conclusion: No signal for adverse pregnancy outcomes or congenital malformations was observed in CZP-exposed pregnancies. Although the limitations of data collected through this methodology (including underreporting, missing information, and absence of a comparator group) should be considered, these data provide reassurance for women with CID who require CZP treatment during pregnancy, and their treating physicians.

Published
2022

22. MOESM1 of What factors could influence physicians' management of women of childbearing age with chronic inflammatory disease? A systematic review of behavioural determinants of clinical inertia

Author

Nelson-Piercy, Catherine, Vlaev, Ivo, Harris, Katie, and Fischer-Betz, Rebecca

Abstract

Additional file 1: Figure S1a (top). Search strings for the chronic rheumatic disease pre-, during- and post-pregnancy searches. Figure S1b (bottom): Search strings for the chronic inflammatory disease pre-, during- and post-pregnancy searches. Figure S2a (top): Analysis flow chart for the CRD search. Figure S2b (bottom). Analysis flow chart for the CID search. Table S1. Summary of publications selected for comprehensive analysis. Table S2. COM-B and associated domains of the TDF [20]. Table S3. TDF domains with definitions and component constructs [20]. Table S4. Quotations from publications on the topic of pregnancy being a complex or challenging condition to treat. Table S5. Quotations from publications in the capability domain. Table S6. Quotations from publications in the motivation domain. Table S7. Quotations from publications in the opportunity domain.

Published
2019
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