Research
Studies
In addition to the information UKTIS collects on a daily basis from healthcare professional enquiries for the purpose of surveillance, UKTIS also conduct and participate in a number of more specific research projects.
UKTIS are currently involved in:
ConcePTION
In April 2019, a landmark public-private partnership called ConcePTION was awarded a five year grant by the Innovative Medicines Initiative to tackle many of the research gaps related to medicines use by pregnant women.
The project, which unites 88 organisations from 22 different countries, aims to build a pan-European ecosystem for generating, monitoring and providing robust information on the safety of medicines use in pregnancy and breastfeeding.
UKTIS is a consortium partner in the project and will work alongside other partners participating in numerous different work packages and sub-tasks.
To find out more about the ConcePTION project please click here to visit the website.
International ‘TIS’ studies
We are collaborating with teratology information services (‘TIS’) around the world to study the effects of a variety of drugs used in pregnancy.
Surveillance
We are aiming to improve the information we collect by giving women the opportunity to provide information directly to UKTIS. Please help us by creating completing the MyBumps questionnaire.
Scientific reports and publications:
2023
Favre G, Richardson JL, Moore A, Geissbühler Y, Jehl V, Oliver A, Shechtman S, Diav-Citrin O, Berlin M, De Haan T, Baud D, Panchaud A, Mor A, Sabidó M, de Souza S, Chambers C, van Rijt-Weetink YRJ, van Puijenbroek EP, Yates LM, Girardin F, Stellfeld M, Winterfeld U. Improving Data Collection in Pregnancy Safety Studies: Towards Standardisation of Data Elements in Pregnancy Reports from Public and Private Partners, A Contribution from the ConcePTION Project. Drug Saf. 2023 Dec 19. doi: 10.1007/s40264-023-01384-3. Epub ahead of print. PMID: 38114757.
Onken M, Lohse L, Coulm B, Beghin D, Richardson JL, Bermejo-Sánchez E, Aguilera C, Bosch M, Cassina M, Chouchana L, De Santis M, Duman MK, Gören MZ, Johnson D, Bera APJ, Kaplan YC, Kennedy D, Kwok S, Lacroix I, Lepelley M, Pistelli A, Schaefer C, Te Winkel B, Uysal N, Winterfeld U, Yakuwa N, Diav-Citrin O, Vial T, Dathe K. Effects of maternal modafinil treatment on fetal development and neonatal growth parameters – a multicenter case series of the European Network of Teratology Information Services (ENITS). Acta Psychiatr Scand. 2023 Dec 18. doi: 10.1111/acps.13643. Epub ahead of print. PMID: 38110225.
Bromley RL, Bickle Graz M, Bluett-Duncan M, Chambers C, Damkier P, Dietrich K, Dolk H, Grant K, Mattson S, Meador KJ, Nordeng H, Oberlander TF, Ornoy A, Revet A, Richardson J, Rovet J, Schuler-Faccini L, Smearman E, Simms V, Vorhees C, Wide K, Wood A, Yates L, Ystrom E, Supraja TA, Adams J. Expert consensus on neurodevelopmental outcomes in pregnancy pharmacovigilance studies. Front Pharmacol. 2023 Jun 1;14:1094698. doi: 10.3389/fphar.2023.1094698. PMID: 37332344; PMCID: PMC10270323.
Richardson JL, Moore A, Bromley RL, Stellfeld M, Geissbühler Y, Bluett-Duncan M, Winterfeld U, Favre G, Alexe A, Oliver AM, van Rijt-Weetink YRJ, Hodson KK, Rezaallah B, van Puijenbroek EP, Lewis DJ, Yates LM. Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project. Drug Saf. 2023 May;46(5):479-491. doi: 10.1007/s40264-023-01291-7. Epub 2023 Mar 28. PMID: 36976447; PMCID: PMC10164024.
Richardson JL, George N, Greenall AJ, Oliver AM, Stephens S, Hodson KK. Cardiac Malformation Risks Following Maternal First Trimester Methylphenidate Use. J Clin Psychiatry. 2023 May 15;84(4):22br14755. doi: 10.4088/JCP.22br14755
Richardson JL, Stephens S, Chappell LC, Campbell H, Amirthalingam G, O’Boyle S, Bukasa A, Knight M, Hodson KK. Monitoring the safety of COVID-19 vaccination in pregnancy in the UK: A national study using the UK Obstetric Surveillance System (UKOSS), UK Teratology Information Service (UKTIS) and Vaccination in Pregnancy (VIP) safety monitoring systems. Obstet Med. 2023 Mar;16(1):40-47. doi: 10.1177/1753495X221076713. Epub 2022 Feb 8. PMID: 37124763; PMCID: PMC10126751.
Richardson JL, Damkier P, Diav-Citrin O, George N, Greenall AJ, Oliver AM, Stephens S, Hodson KK. A critical appraisal of controlled studies investigating malformation risks following pregabalin use in early pregnancy. Br J Clin Pharmacol. 2023 Feb;89(2):630-640. doi: 10.1111/bcp.15607. Epub 2022 Dec 5. PMID: 36403130.
Dao K, Shechtman S, Diav-Citrin O, George N, Richardson JL, Rollason V, Pistelli A, Eleftheriou G, Berlin M, Ekobena P, Rousson V, Addor MC, Baud D, Buclin T, Panchaud A, Winterfeld U. Reproductive Safety of Trazodone After Maternal Exposure in Early Pregnancy: A Comparative ENTIS Cohort Study. J Clin Psychopharmacol. 2023 Jan-Feb 01;43(1):12-19. doi: 10.1097/JCP.0000000000001630. PMID: 36584245; PMCID: PMC9803380.
Maisonneuve, E.; Gerbier, E.; Tauqeer, F.; Pomar, L.; Favre, G.; Winterfeld, U.; Passier, A.; Oliver, A.; Baud, D.; Nordeng, H.; Ceulemans, M.; Panchaud, A. Determinants of Vaccination and Willingness to Vaccinate against COVID-19 among Pregnant and Postpartum Women during the Third Wave of the Pandemic: A European Multinational Cross-Sectional Survey. Viruses 2023, 15(5), 1090; https://doi.org/10.3390/v15051090
Araya, R.A.; Tauqeer, F.; Ceulemans, M.; Gerbier, E.; Maisonneuve, E.; Passier, A.; Oliver, A.; Panchaud, A.; Lupattelli, A.; Nordeng, H. Pregnancy- and Birth-Related Experiences among Postpartum Women during the Third Wave of the COVID-19 Pandemic—A Multinational European Study. Pharmacoepidemiology 2023, 2, 54-67. https://doi.org/10.3390/pharma2010006
Tauqeer F, Ceulemans M, Gerbier E, Passier A, Oliver A, Foulon V, Panchaud A, Lupattelli A, Nordeng H. Mental health of pregnant and postpartum women during the third wave of the COVID-19 pandemic: a European cross-sectional study. BMJ Open. 2023 Jan 11;13(1):e063391. doi: 10.1136/bmjopen-2022-063391. PMID: 36631239; PMCID: PMC9835449.
2022
Russell MD, Dey M, Flint J, Davie P, Allen A, Crossley A, Frishman M, Gayed M, Hodson K, Khamashta M, Moore L, Panchal S, Piper M, Reid C, Saxby K, Schreiber K, Senvar N, Tosounidou S, van de Venne M, Warburton L, Williams D, Yee CS, Gordon C, Giles I; BSR Standards, Audit and Guidelines Working Group. British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: immunomodulatory anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford). 2022 Nov 2:keac551. doi: 10.1093/rheumatology/keac551. Erratum in: Rheumatology (Oxford). 2022 Dec 13;: PMID: 36318966.
Richardson, J.L.; Damkier, P.; Diav-Citrin, O.; George, N.; Greenall, A.J.; Oliver, A.M; Stephens, S.; Hodson, K.K. A critical appraisal of controlled studies investigating malformation risks following pregabalin use in early pregnancy. Br J Clin Pharmacol. 2022 Nov 20. doi: 10.1111/bcp.15607.
Dao, K.; Shechtman, S.; Diav-Citrin, O.; George, N.; Richardson, J.L.; Rollason, V.; Pistelli, A.; Eleftheriou, G.; Berlin, M.; Ekobena, P.; Rousson, V.; Addor, M.; Baud, D.; Buclin, T.; Panchaud, A.; Winterfeld, U. Reproductive Safety of Trazodone After Maternal Exposure in Early Pregnancy: A Comparative ENTIS Cohort Study. Journal of Clinical Psychopharmacology: November 29, 2022 – Volume – Issue – 10.1097/JCP.0000000000001630 doi: 10.1097/JCP.0000000000001630
Damkier P, Hodson K. Shelter from the storm: Acetaminophen (paracetamol) in pregnancy, urogenital malformations, and childhood neurodevelopment. Obstet Med. 2022 Jun;15(2):77-78. doi: 10.1177/1753495X221080883. Epub 2022 Feb 22.
Nana M, Hodson K, Lucas N, Camporota L, Knight M, Nelson-Piercy C. Diagnosis and management of covid-19 in pregnancy. BMJ. 2022 Apr 26;377:e069739. doi: 10.1136/bmj-2021-069739.PMID: 35473709
Gerbier E, Favre G, Tauqeer F, Winterfeld U, Stojanov M, Oliver A, Passier A, Nordeng H, Pomar L, Baud D, Panchaud A, Meyer-Massetti C, Ceulemans M. Self-Reported Medication Use among Pregnant and Postpartum Women during the Third Wave of the COVID-19 Pandemic: A European Multinational Cross-Sectional Study. Int J Environ Res Public Health. 2022 Apr 27;19(9):5335. doi: 10.3390/ijerph19095335.
Ceulemans, M.; Foulon, V.; Panchaud, A.; Winterfeld, U.; Pomar, L.; Lambelet, V.; Cleary, B.; O’Shaughnessy, F.; Passier, A.; Richardson, J.L.; Nordeng, H. Self-Reported Medication Use among Pregnant and Breastfeeding Women during the COVID-19 Pandemic: A Cross-Sectional Study in Five European Countries. Int. J. Environ. Res. Public Health 2022, 19, 1389. https://doi.org/10.3390/ijerph19031389
Ceulemans M, Sillis L, Foulon V, Panchaud A, Winterfeld U, Pomar L, Cleary B, O’Shaughnessy F, Passier A, Richardson JL, Nordeng H. Comment to “Pregnancy and COVID-19, focus on vaccine and pharmacological treatment”. J Reprod Immunol. 2022 Aug;152:103639. doi: 10.1016/j.jri.2022.103639. Epub 2022 May 10.
2021
RECOVERY Collaborative Group. Azithromycin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet 2021; 397: 605-12.
RECOVERY Collaborative Group. Dexamethasone in hospitalized patients with Covid-19. NEJM 2021;384: 693-704
Damkier P, Kaplan YC, Shechtman S, Diav-Citrin O, Cassina M, Weber-Schoendorfer C, Cleary B, Hodson K. Ondansetron should never be used in pregnancy: Against: Ondansetron in pregnancy revisited. BJOG published online 29/9/20.
Ceulemans M, Foulon V, Panchaud A, Winterfeld U, Pomar L, Lambelet V, Cleary B, O’Shaughnessy F, Passier A, Richardson JL, Allegaert K, Nordeng H. Vaccine willingness and impact of the COVID-19 pandemic on women’s perinatal experiences and practices – a multinational, cross-sectional study covering the first wave of the pandemic. Int J Environ Res Public Health published online 24/3/21
Ceulemans M, Foulon V, Ngo E, Panchaud A, Winterfeld U, Pomar L, Lambelet V, Cleary B, O’Shaughnessy F, Passier A, Richardson JL, Hompes T, Nordeng H. Mental health status of pregnant and breastfeeding women during the COVID-19 pandemic-A multinational cross-sectional study. Acta Obstet Gynecol Scand. 2021 Jul;100(7):1219-1229. doi: 10.1111/aogs.14092. Epub 2021 Feb 13.
2020
Michie LA, Hodson KK. Ondansetron for nausea and vomiting in pregnancy: re-evaluating the teratogenic risk. Obstet Med 2020; 13: 3-4.
Cauldwell M, Steer PJ, Curtis SL, Mohan A, Dockree S, Mackillop L, Parry HM, Oliver J, Sterrenberg M, Wallace S, Malin G, Partridge G, Freeman LJ, Bolger AP, Siddiqui F, Wilson D, Simpson M, Walker N, Hodson K, Thomas K, Bredaki F, Mercaldi R, Walker F, Johnson MR. Maternal and fetal outcomes in pregnancies complicated by Marfan syndrome. Heart 2019; 105:1725-31.
Weber-Schoendorfer C, Kayser A, Tissen-Diabaté T, Winterfeld U, Eleftheriou G, Te Winkel B, Diav-Citrin O, Greenall A, Hoeltzenbein M, Schaefer C. Fetotoxic risk of AT1 blockers exceeds that of angiotensin-converting enzyme inhibitors: an observational study. J Hypertens. 2020 Jan;38(1):133-141. doi: 10.1097/HJH.0000000000002233. PMID: 31568057.
2019
Richardson JL, Martin F, Dunstan H, Greenall A, Stephens S, Yates LM, Thomas SHL. Pregnancy outcomes following maternal venlafaxine use: A prospective observational comparative cohort study. Reproductive Toxicology. 2019 Mar;84:108-113
Kaplan YC, Richardson JL, Keskin-Arslan E, Erol-Coskun H, Kennedy D. Use of ondansetron during pregnancy and the risk of major congenital malformations: A systematic review and meta-analysis. Reproductive Toxicology. 2019 Mar 5;86:1-13
McParlin C, Hodson K, Barnes AC, Taylor R, Robson SC, Araujo-Soares V. Views, experience and adherence among pregnant women with gestational diabetes participating in a weight loss study (WELLBABE).Diabetic Medicine. 2019 Feb;36(2):195-202
Cauldwell M, Steer PJ, Bonner S, Asghar O, Swan L, Hodson K, Head CEG, Jakes AD, Walker N, Simpson M, Bolger AP, Siddiqui F, English KM, Maudlin L, Abraham D, Sands AJ, Mohan AR, Curtis SL, Coats L, Johnson MR. Retrospective UK multicentre study of the pregnancy outcomes of women with a Fontan repair. Heart. 2018 Apr;104(5):401-406.
2018
Panchaud A, Rousson V, Vial T, Bernard N, Baud D, Amar E, De Santis M, Pistelli A, Dautriche A, Beau-Salinas F, Cassina M, Dunstan H, Passier A, Kaplan YC, Duman MK, Maňáková E, Eleftheriou G, Klinger G, Winterfeld U, Rothuizen LE, Buclin T, Csajka C, Hernandez-Diaz S. Pregnancy outcomes in women on metformin for diabetes or other indications among those seeking teratology information services. Br J Clin Pharmacol. 2018 Mar;84(3):568-578.
2017
Richardson JL, Stephens S, Yates LM, Diav-Citrin O, Arnon J, Beghin D, Kayser A, Kennedy D, Cupitt D, Te Winkel B, Peltonen M, Kaplan YC, Thomas SH. Pregnancy outcomes after maternal varenicline use; analysis of surveillance data collected by the European Network of Teratology Information Services. Reprod Toxicol. 2017 Jan;67:26-34.
Charlton RA, McGrogan A, Snowball J, Yates LM, Wood A, Clayton-Smith J, Smithson WH, Richardson JL, McHugh N, Thomas SH, Baker GA, Bromley R. Sensitivity of the UK Clinical Practice Research Datalink to Detect Neurodevelopmental Effects of Medicine Exposure in Utero: Comparative Analysis of an Antiepileptic Drug-Exposed Cohort. Drug Saf. 2017 May;40(5):387-397.
McAllister-Williams RH, Baldwin DS, Cantwell R, Easter A, Gilvarry E, Glover V, Green L, Gregoire A, Howard LM, Jones I, Khalifeh H, Lingford-Hughes A, McDonald E, Micali N, Pariante CM, Peters L, Roberts A, Smith NC, Taylor D, Wieck A, Yates LM, Young AH. British Association for Psychopharmacology consensus guidance on the use of psychotropic medication preconception, in pregnancy and postpartum 2017. J Psychopharmacol. 2017 May;31(5):519-552.
2016
Winterfeld U, Merlob P, Baud D, Rousson V, Panchaud A, Rothuizen LE, Bernard N, Vial T, Yates LM, Pistelli A, Ellfolk M, Eleftheriou G, de Vries LC, Jonville-Bera AP, Kadioglu M, Biollaz J, Buclin T. Pregnancy outcome following maternal exposure to pregabalin may call for concern. Neurology. 2016 Jun 14;86(24):2251-7.
2015
Weber-SchoendorferC, Oppermann M, Wacker E, Bernard N; network of French pharmacovigilance centres, Beghin D, Cuppers-Maarschalkerweerd B, Richardson JL, Rothuizen LE, Pistelli A, Malm H, Eleftheriou G, Kennedy D, KadiogluDuman M, Meister R, Schaefer C.Pregnancy outcome after TNF-α inhibitor therapy during the first trimester: a prospective multicentre cohort study. Br J ClinPharmacol. 2015; Mar 25.
Winterfeld U, Klinger G, Panchaud A, Stephens S, Arnon J, Malm H, Te Winkel B, Clementi M, Pistelli A, Maňáková E, Eleftheriou G, Merlob P, Kaplan YC, Buclin T, Rothuizen LE. Pregnancy Outcome Following Maternal Exposure to Mirtazapine: A Multicenter, Prospective Study.J Clin Psychopharmacol. 2015; Mar 31.
2014
Dunstan H, Mill A, Stephens S, Yates L, Thomas S. Pregnancy outcome following maternal use of zanamivir or oseltamivir during the 2009 influenza A/H1N1 pandemic: a national prospective surveillance study. BJOG 2014; Mar 7.
2013
Winterfeld U, Allignol A, Panchaud A, Rothuizen LE, Merlob P, Cuppers-Maarschalkerweerd B, Vial T, Stephens S, Clementi M, De Santis M, Pistelli A, Berlin M, Eleftheriou G, Manáková E, Buclin T. Pregnancy outcome following maternal exposure to statins: a multicentre prospective study. BJOG 2013; 120: 463–71.
Jones D, Stephens S, Yates LM, Thomas SHL. Prospective outcomes following acute exposure to carbamate insecticides in pregnancy. Clinical Toxicology 2013; 51:p355.
Fujii H, Goel A, Bernard N, Pistelli A, Yates LM, Stephens S, Han JY, Matsi D, Edwell F, Finarson TR, Koren G, Einarson A. Pregnancy outcomes following gabapentin use: Results of a prospective comparative cohort study, Neurology. 2013 April 23;80(17):1565-1570.
Richardson JL, Jones D, Dunstan HJ, Maitra S, Stephens S, Yates LM, Thomas SH. Gestational exposure to varenicline. Reproductive Toxicology, 2013; 37:p85.
2012
Hoeltzenbein M, Elefant E, Vial T, Finkel-Pekarsky V, Stephens S, Clementi M, Allignol A, Weber-Schoendorfer C, Schaefer C. Teratogenicity of mycophenolate confirmed in a prospective study of the European Network of Teratology Information Services. Am J Med Genet A. 2012 Mar;158A(3):588-96.
Einarson A, Smart K, Vial T, Diav-Citrin O, Yates L, Stephens S, Pistelli A, Kennedy D, Taylor T, Panchaud A, Malm H, Koren G, Einarson TR. Rates of major malformations in infants following exposure to duloxetine during pregnancy: a preliminary report. J Clin Psychiatr 2012; 73: 1471.
Thomas SHL, Yates LM. Prescribing without evidence – pregnancy. Br J Clin Pharmacol. 2012; 74: 691–7.
Yates LM, Thomas SHL. Prescribing medicines in pregnancy. Medicine 2012; 40: 386–90.
Jones D, Stephens S, Yates L, Dunstan H, Richardson JL, Greenall A, Thomas SHL. Fetal outcomes following fentanyl exposure in pregnancy. Clin Toxicol 2012; 50: 328.
Jones D, Stephens S, Yates L, Dunstan H, Richardson JL, Greenall A, Thomas SHL. Fetal outcomes following dosulepin overdose in pregnancy, Clin Toxicol 2012; 50: 327–8.
2011
Stephens S, Adams S, Richardson JL, Yates L, Thomas SHL. Outcome of pregnancy after first trimester exposure to venlafaxine. Birth Defects Research Part A: Clinical and Molecular Teratology. 2011; 91(5): 414.
Russell P, Yates L, Grant E, Golightly P. “Drugs in Pregnancy and Lactation” in Walker RS, Whitlesea C. Clinical Pharmacy & Therapeutics, 5th Edition, Churchill Livingstone 2011, Page 739-752.
2010
Yates L, Pierce M, Stephens S, Mill AC, Spark P, Kurinczuk JJ, Valappil M, Brocklehurst P, Thomas SH, Knight M. Influenza A/H1N1v in pregnancy: an investigation of the characteristics and management of affected women and the relationship to pregnancy outcomes for mother and infant. Health Technology Assessment. 2010; 14(34):109-82.
Jones D, Stephens S, Richardson JL, Yates L, Thomas SHL. The fetal effects of ibuprofen overdose in the third trimester of pregnancy and the risk of premature closure of the ductus arteriosus. Clinical Toxicology. 2010; 48 (3): 240-318.
Richardson J.L, Stephens S, Jones D, Yates L. Fetal effects of diazepam overdose during pregnancy. Clinical Toxicology. 2010; 48 (3): 281.
Stephens S, Yates L, Chincholkar V, Thomas SHL. Outcome of pregnancy after maternal exposure to mifepristone. Birth Defects Research Part A: Clinical and Molecular Teratology. 2010; 88 (5): 433.
2009
Stephens S, Wilson G. Principles in pregnant women: guide to general principles. Prescriber. 2009; 20 (23/24): 43-46.
Stephens S, Wilson G, Jones D, Thomas SHL. Preliminary data on the use of cannabis in pregnancy. Reproductive Toxicology. 2009; 28 (2): 117-284.
Wilson G, Stephens S, Jones D, Thomas SHL. Preliminary data on the use of hepatitis A and B vaccines during pregnancy. Reproductive Toxicology. 2009; 28 (2): 117-284.
Wilson G, Jones D, Stephens S, Bradley S, McElhatton P, Thomas SHL. Preliminary data on exposure to trichloroethylene during pregnancy. Clinical Toxicology. 2009; 47 (5): 436-510.