FERN: is it possible to conduct a randomised controlled trial of intervention or expectant management for early-onset selective fetal growth restriction in monochorionic twin pregnancy – protocol for a prospective multicentre mixed-methods feasibility study
Introduction Selective fetal growth restriction (sFGR) in monochorionic twin pregnancy, defined as an estimated fetal weight (EFW) of one twin <10th centile and EFW discordance ≥25%, is associated with stillbirth and neurodisability for both twins. The condition poses unique management diffic...
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author | Kerry Woolfall Jamie J Kirkham Jane Sandall Mariana Popa Enrico Lopriore Mark Turner Shakila Thangaratinam Aris T Papageorghiou Andrew Sharp Lawrence Impey Andy Healey Jessica Mendoza Asma Khalil Dharmintra Pasupathy Brigitte Vollmer Zarko Alfirevic Rajeswari Parasuraman Jan Deprest Richard Edmund Ashcroft Kurt Hecher Smriti Prasad Baskaran Thilaganathan Richard J Jackson Tracy Karen Mitchell Natasha Fenwick Monique C Haak Liesbeth Lewi Shauna Leven Fabricio Da Silva Costa Odai Yaghi Tracey Ricketts George Attilakos Carolyn Bailie Christine Cornforth Mark Denbow Louise Hardman Jane Harrold Joel Marsden Tommy Mousa Surabhi Nanda Michelle Watson Karen Wilding Dilly Anumba Edward D Johnstone Yoav Yinon Ahmet Baschat |
author_facet | Kerry Woolfall Jamie J Kirkham Jane Sandall Mariana Popa Enrico Lopriore Mark Turner Shakila Thangaratinam Aris T Papageorghiou Andrew Sharp Lawrence Impey Andy Healey Jessica Mendoza Asma Khalil Dharmintra Pasupathy Brigitte Vollmer Zarko Alfirevic Rajeswari Parasuraman Jan Deprest Richard Edmund Ashcroft Kurt Hecher Smriti Prasad Baskaran Thilaganathan Richard J Jackson Tracy Karen Mitchell Natasha Fenwick Monique C Haak Liesbeth Lewi Shauna Leven Fabricio Da Silva Costa Odai Yaghi Tracey Ricketts George Attilakos Carolyn Bailie Christine Cornforth Mark Denbow Louise Hardman Jane Harrold Joel Marsden Tommy Mousa Surabhi Nanda Michelle Watson Karen Wilding Dilly Anumba Edward D Johnstone Yoav Yinon Ahmet Baschat |
author_sort | Kerry Woolfall |
collection | DOAJ |
description | Introduction Selective fetal growth restriction (sFGR) in monochorionic twin pregnancy, defined as an estimated fetal weight (EFW) of one twin <10th centile and EFW discordance ≥25%, is associated with stillbirth and neurodisability for both twins. The condition poses unique management difficulties: on the one hand, continuation of the pregnancy carries a risk of death of the smaller twin, with a high risk of co-twin demise (40%) or co-twin neurological sequelae (30%). On the other, early delivery to prevent the death of the smaller twin may expose the larger twin to prematurity, with the associated risks of long-term physical, emotional and financial costs from neurodisability, such as cerebral palsy.When there is severe and early sFGR, before viability, delivery is not an option. In this scenario, there are currently three main management options: (1) expectant management, (2) selective termination of the smaller twin and (3) placental laser photocoagulation of interconnecting vessels. These management options have never been investigated in a randomised controlled trial (RCT). The best management option is unknown, and there are many challenges for a potential RCT. These include the rarity of the condition resulting in a small number of eligible pregnancies, uncertainty about whether pregnant women will agree to participate in such a trial and whether they will agree to be randomised to expectant management or active fetal intervention, and the challenges of robust and long-term outcome measures. Therefore, the main objective of the FERN study is to assess the feasibility of conducting an RCT of active intervention vs expectant management in monochorionic twin pregnancies with early-onset (prior to 24 weeks) sFGR.Methods and analysis The FERN study is a prospective mixed-methods feasibility study. The primary objective is to recommend whether an RCT of intervention vs expectant management of sFGR in monochorionic twin pregnancy is feasible by exploring women’s preference, clinician’s preference, current practice and equipoise and numbers of cases. To achieve this, we propose three distinct work packages (WPs). WP1: A Prospective UK Multicentre Study, WP2A: a Qualitative Study Exploring Parents’ and Clinicians’ Views and WP3: a Consensus Development to Determine Feasibility of a Trial. Eligible pregnancies will be recruited to WP1 and WP2, which will run concurrently. The results of these two WPs will be used in WP3 to develop consensus on a future definitive study. The duration of the study will be 53 months, composed of 10 months of setup, 39 months of recruitment, 42 months of data collection, and 5 months of data analysis, report writing and recommendations. The pragmatic sample size for WP1 is 100 monochorionic twin pregnancies with sFGR. For WP2, interviews will be conducted until data saturation and sample variance are achieved, that is, when no new major themes are being discovered. Based on previous similar pilot studies, this is anticipated to be approximately 15–25 interviews in both the parent and clinician groups. Engagement of at least 50 UK clinicians is planned for WP3.Ethics and dissemination This study has received ethical approval from the Health Research Authority (HRA) South West—Cornwall and Plymouth Ethics Committee (REC reference 20/SW/0156, IRAS ID 286337). All participating sites will undergo site-specific approvals for assessment of capacity and capability by the HRA. The results of this study will be published in peer-reviewed journals and presented at national and international conferences. The results from the FERN project will be used to inform future studies.Trial registration number This study is included in the ISRCTN Registry (ISRCTN16879394) and the NIHR Central Portfolio Management System (CPMS), CRN: Reproductive Health and Childbirth Specialty (UKCRN reference 47201). |
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spelling | doaj-art-fd2d44b2827744f9909af7c79ccb60452025-01-27T07:05:08ZengBMJ Publishing GroupBMJ Open2044-60552024-08-0114810.1136/bmjopen-2023-080021FERN: is it possible to conduct a randomised controlled trial of intervention or expectant management for early-onset selective fetal growth restriction in monochorionic twin pregnancy – protocol for a prospective multicentre mixed-methods feasibility studyKerry Woolfall0Jamie J Kirkham1Jane Sandall2Mariana Popa3Enrico Lopriore4Mark Turner5Shakila Thangaratinam6Aris T Papageorghiou7Andrew Sharp8Lawrence Impey9Andy Healey10Jessica Mendoza11Asma Khalil12Dharmintra Pasupathy13Brigitte Vollmer14Zarko Alfirevic15Rajeswari Parasuraman16Jan Deprest17Richard Edmund Ashcroft18Kurt Hecher19Smriti Prasad20Baskaran Thilaganathan21Richard J Jackson22Tracy Karen Mitchell23Natasha Fenwick24Monique C Haak25Liesbeth Lewi26Shauna Leven27Fabricio Da Silva Costa28Odai Yaghi29Tracey Ricketts30George Attilakos31Carolyn Bailie32Christine Cornforth33Mark Denbow34Louise Hardman35Jane Harrold36Joel Marsden37Tommy Mousa38Surabhi Nanda39Michelle Watson40Karen Wilding41Dilly Anumba42Edward D Johnstone43Yoav Yinon44Ahmet Baschat45Department of Public Health, Policy and Systems, Institute of Population Health, University of Liverpool, Liverpool, UKsenior lecturer in biostatisticsprofessor of social science and women’s healthDepartment of Public Health, Policy and Systems, Institute of Population Health, University of Liverpool, Liverpool, UKDivision of Neonatology, Willem-Alexander Children’s Hospital, Leiden University Medical Center, Leiden, The NetherlandsDepartment of Women’s and Children’s Health, Faculty of Health & Life Sciences, Harris Wellbeing of Women Research Centre, University of Liverpool, Liverpool, UK5 Liverpool Women`s Hospital NHS Foundation Trust, Liverpool, UKFetal Medicine Unit, St George`s University Hospital, London, UKDepartment of Women’s and Children’s Health, Faculty of Health & Life Sciences, Harris Wellbeing of Women Research Centre, University of Liverpool, Liverpool, UKDepartment of Fetal Medicine, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UKHealth Service and Population Research Department, King’s College London, London, UKPPIE, FERN project, Liverpool, UKVascular Biology Research Centre, Molecular and Clinical Sciences Research Institute, St George`s University of London, London, UKReproduction and Perinatal Centre, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, AustraliaClinical Neurosciences, Faculty of Medicine, University of Southampton, Southampton, UKDepartment of Women’s and Children’s Health, Faculty of Health & Life Sciences, Harris Wellbeing of Women Research Centre, University of Liverpool, Liverpool, UKWessex Fetal Maternal Medicine unit, University Southampton NHS Foundation Trust, Princess Anne Hospital, Southampton, UKFetal Medicine Unit, Dept. Obstetrics and Gynecology, University Hospitals Leuven, Leuven, BelgiumSchool of Law, City University of London, London, UKDepartment of Obstetrics and Fetal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, GermanyFetal Medicine Unit, St George`s University Hospital, London, UKFetal Medicine Unit, St George`s University Hospital, London, UKLiverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK1 Public Health, Policy and Systems, University of Liverpool, Liverpool, UKTwins Trust, The Manor House, Aldershot, UKObstetrics and Gynaecology, Leiden University Medical Center, Leiden, NetherlandsDept of Development and Regeneration, Biomedical Sciences, KU Leuven, Leuven, BelgiumTwins Trust, The Manor House, Aldershot, UK3 Maternal Fetal Medicine Unit, Gold Coast University Hospital, Southport, Queensland, AustraliaFetal Medicine Unit, St George`s University Hospital, London, UKDepartment of Women’s and Children’s Health, Faculty of Health & Life Sciences, Harris Wellbeing of Women Research Centre, University of Liverpool, Liverpool, UKWomen`s Health Division, University College London Hospitals NHS Foundation Trust, Institute for Women`s Health, University College London, London, UKRoyal Jubilee Maternity Hospital, Belfast, UKDepartment of Women’s and Children’s Health, Faculty of Health & Life Sciences, Harris Wellbeing of Women Research Centre, University of Liverpool, Liverpool, UKFetal Medicine Unit, St Michael`s Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol, UKLiverpool Women’s NHS Foundation Trust, Liverpool, UKDepartment of Women’s and Children’s Health, Faculty of Health & Life Sciences, Harris Wellbeing of Women Research Centre, University of Liverpool, Liverpool, UKPPIE, FERN project, Liverpool, UKUniversity of Leicester, Leicester, UKGuy`s and St Thomas`s Hospital, London, UKPPIE, FERN project, Liverpool, UKClinical Directorate, Faulty of Health and Life Sciences, University of Liverpool, Liverpool, UKAcademic Unit of Reproductive and Developmental Medicine, Department of Human Metabolism, University of Sheffield, Sheffield, UKMaternal and Fetal Health Research Centre, Division of Developmental Biology and Medicine, School of Medical Sciences, Faculty of Medicine Biology and Health, University of Manchester, Manchester, UKDepartment of Obstetrics and Gynecology, Chaim Sheba Medical Center, Tel-Hashomer, Ramat-Gan 52621, IsraelJohns Hopkins Center for Fetal Therapy Department of Gynecology & Obstetrics, Johns Hopkins University, Baltimore, Maryland, USAIntroduction Selective fetal growth restriction (sFGR) in monochorionic twin pregnancy, defined as an estimated fetal weight (EFW) of one twin <10th centile and EFW discordance ≥25%, is associated with stillbirth and neurodisability for both twins. The condition poses unique management difficulties: on the one hand, continuation of the pregnancy carries a risk of death of the smaller twin, with a high risk of co-twin demise (40%) or co-twin neurological sequelae (30%). On the other, early delivery to prevent the death of the smaller twin may expose the larger twin to prematurity, with the associated risks of long-term physical, emotional and financial costs from neurodisability, such as cerebral palsy.When there is severe and early sFGR, before viability, delivery is not an option. In this scenario, there are currently three main management options: (1) expectant management, (2) selective termination of the smaller twin and (3) placental laser photocoagulation of interconnecting vessels. These management options have never been investigated in a randomised controlled trial (RCT). The best management option is unknown, and there are many challenges for a potential RCT. These include the rarity of the condition resulting in a small number of eligible pregnancies, uncertainty about whether pregnant women will agree to participate in such a trial and whether they will agree to be randomised to expectant management or active fetal intervention, and the challenges of robust and long-term outcome measures. Therefore, the main objective of the FERN study is to assess the feasibility of conducting an RCT of active intervention vs expectant management in monochorionic twin pregnancies with early-onset (prior to 24 weeks) sFGR.Methods and analysis The FERN study is a prospective mixed-methods feasibility study. The primary objective is to recommend whether an RCT of intervention vs expectant management of sFGR in monochorionic twin pregnancy is feasible by exploring women’s preference, clinician’s preference, current practice and equipoise and numbers of cases. To achieve this, we propose three distinct work packages (WPs). WP1: A Prospective UK Multicentre Study, WP2A: a Qualitative Study Exploring Parents’ and Clinicians’ Views and WP3: a Consensus Development to Determine Feasibility of a Trial. Eligible pregnancies will be recruited to WP1 and WP2, which will run concurrently. The results of these two WPs will be used in WP3 to develop consensus on a future definitive study. The duration of the study will be 53 months, composed of 10 months of setup, 39 months of recruitment, 42 months of data collection, and 5 months of data analysis, report writing and recommendations. The pragmatic sample size for WP1 is 100 monochorionic twin pregnancies with sFGR. For WP2, interviews will be conducted until data saturation and sample variance are achieved, that is, when no new major themes are being discovered. Based on previous similar pilot studies, this is anticipated to be approximately 15–25 interviews in both the parent and clinician groups. Engagement of at least 50 UK clinicians is planned for WP3.Ethics and dissemination This study has received ethical approval from the Health Research Authority (HRA) South West—Cornwall and Plymouth Ethics Committee (REC reference 20/SW/0156, IRAS ID 286337). All participating sites will undergo site-specific approvals for assessment of capacity and capability by the HRA. The results of this study will be published in peer-reviewed journals and presented at national and international conferences. The results from the FERN project will be used to inform future studies.Trial registration number This study is included in the ISRCTN Registry (ISRCTN16879394) and the NIHR Central Portfolio Management System (CPMS), CRN: Reproductive Health and Childbirth Specialty (UKCRN reference 47201).https://bmjopen.bmj.com/content/14/8/e080021.full |
spellingShingle | Kerry Woolfall Jamie J Kirkham Jane Sandall Mariana Popa Enrico Lopriore Mark Turner Shakila Thangaratinam Aris T Papageorghiou Andrew Sharp Lawrence Impey Andy Healey Jessica Mendoza Asma Khalil Dharmintra Pasupathy Brigitte Vollmer Zarko Alfirevic Rajeswari Parasuraman Jan Deprest Richard Edmund Ashcroft Kurt Hecher Smriti Prasad Baskaran Thilaganathan Richard J Jackson Tracy Karen Mitchell Natasha Fenwick Monique C Haak Liesbeth Lewi Shauna Leven Fabricio Da Silva Costa Odai Yaghi Tracey Ricketts George Attilakos Carolyn Bailie Christine Cornforth Mark Denbow Louise Hardman Jane Harrold Joel Marsden Tommy Mousa Surabhi Nanda Michelle Watson Karen Wilding Dilly Anumba Edward D Johnstone Yoav Yinon Ahmet Baschat FERN: is it possible to conduct a randomised controlled trial of intervention or expectant management for early-onset selective fetal growth restriction in monochorionic twin pregnancy – protocol for a prospective multicentre mixed-methods feasibility study BMJ Open |
title | FERN: is it possible to conduct a randomised controlled trial of intervention or expectant management for early-onset selective fetal growth restriction in monochorionic twin pregnancy – protocol for a prospective multicentre mixed-methods feasibility study |
title_full | FERN: is it possible to conduct a randomised controlled trial of intervention or expectant management for early-onset selective fetal growth restriction in monochorionic twin pregnancy – protocol for a prospective multicentre mixed-methods feasibility study |
title_fullStr | FERN: is it possible to conduct a randomised controlled trial of intervention or expectant management for early-onset selective fetal growth restriction in monochorionic twin pregnancy – protocol for a prospective multicentre mixed-methods feasibility study |
title_full_unstemmed | FERN: is it possible to conduct a randomised controlled trial of intervention or expectant management for early-onset selective fetal growth restriction in monochorionic twin pregnancy – protocol for a prospective multicentre mixed-methods feasibility study |
title_short | FERN: is it possible to conduct a randomised controlled trial of intervention or expectant management for early-onset selective fetal growth restriction in monochorionic twin pregnancy – protocol for a prospective multicentre mixed-methods feasibility study |
title_sort | fern is it possible to conduct a randomised controlled trial of intervention or expectant management for early onset selective fetal growth restriction in monochorionic twin pregnancy protocol for a prospective multicentre mixed methods feasibility study |
url | https://bmjopen.bmj.com/content/14/8/e080021.full |
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