R Townsend1,2, F Sileo1, L Stocker3, H Kumbay4, P Healy5,6, S Gordijn7, W Ganzevoort8, I Beune7, A Baschat9, L Kenny10, F Bloomfield11, M Daly12, D Devane5,6, A Papageorghiou1,2,13, A Khalil1,2. 1. Fetal Medicine Unit, St George's University Hospitals NHS Foundation Trust, London, UK. 2. Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute, St George's University of London, London, UK. 3. Women and Children Division, University Hospital Southampton NHS Foundation Trust, Princess Anne Hospital, Southampton, UK. 4. GKT School of Medicine, King's College, London, UK. 5. Health Research Board - Trials Methodology Research Network, Galway, Ireland. 6. School of Nursing and Midwifery, NUI Galway, Galway, Ireland. 7. Department of Obstetrics and Gynecology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. 8. Department of Obstetrics and Gynecology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. 9. Johns Hopkins Center for Fetal Therapy, Baltimore, MD, USA. 10. The Irish Centre for Fetal and Neonatal Translational Research (INFANT), University College Cork, Cork, Ireland. 11. Liggins Institute, University of Auckland, Auckland, New Zealand. 12. Advocacy and Policymaking, Irish Neonatal Health Alliance, Wicklow, Ireland. 13. Nuffield Department of Women's & Reproductive Health, University of Oxford, John Radcliffe Hospital Women's Centre, Oxford, UK.
Abstract
OBJECTIVE: Although fetal growth restriction (FGR) is well known to be associated with adverse outcomes for the mother and offspring, effective interventions for the management of FGR are yet to be established. Trials reporting interventions for the prevention and treatment of FGR may be limited by heterogeneity in the underlying pathophysiology. The aim of this study was to conduct a systematic review of outcomes reported in randomized controlled trials (RCTs) assessing interventions for the prevention or treatment of FGR, in order to identify and categorize the variation in outcome reporting. METHODS: MEDLINE, EMBASE and The Cochrane Library were searched from inception until August 2018 for RCTs investigating therapies for the prevention and treatment of FGR. Studies were assessed systematically and data on outcomes that were reported in the included studies were extracted and categorized. The methodological quality of the included studies was assessed using the Jadad score. RESULTS: The search identified 2609 citations, of which 153 were selected for full-text review and 72 studies (68 trials) were included in the final analysis. There were 44 trials relating to the prevention of FGR and 24 trials investigating interventions for the treatment of FGR. The mean Jadad score of all studies was 3.07, and only nine of them received a score of 5. We identified 238 outcomes across the included studies. The most commonly reported were birth weight (88.2%), gestational age at birth (72.1%) and small-for-gestational age (67.6%). Few studies reported on any measure of neonatal morbidity (27.9%), while adverse effects of the interventions were reported in only 17.6% of trials. CONCLUSIONS: There is significant variation in outcome reporting across RCTs of therapies for the prevention and treatment of FGR. The clinical applicability of future research would be enhanced by the development of a core outcome set for use in future trials.
OBJECTIVE: Although fetal growth restriction (FGR) is well known to be associated with adverse outcomes for the mother and offspring, effective interventions for the management of FGR are yet to be established. Trials reporting interventions for the prevention and treatment of FGR may be limited by heterogeneity in the underlying pathophysiology. The aim of this study was to conduct a systematic review of outcomes reported in randomized controlled trials (RCTs) assessing interventions for the prevention or treatment of FGR, in order to identify and categorize the variation in outcome reporting. METHODS: MEDLINE, EMBASE and The Cochrane Library were searched from inception until August 2018 for RCTs investigating therapies for the prevention and treatment of FGR. Studies were assessed systematically and data on outcomes that were reported in the included studies were extracted and categorized. The methodological quality of the included studies was assessed using the Jadad score. RESULTS: The search identified 2609 citations, of which 153 were selected for full-text review and 72 studies (68 trials) were included in the final analysis. There were 44 trials relating to the prevention of FGR and 24 trials investigating interventions for the treatment of FGR. The mean Jadad score of all studies was 3.07, and only nine of them received a score of 5. We identified 238 outcomes across the included studies. The most commonly reported were birth weight (88.2%), gestational age at birth (72.1%) and small-for-gestational age (67.6%). Few studies reported on any measure of neonatal morbidity (27.9%), while adverse effects of the interventions were reported in only 17.6% of trials. CONCLUSIONS: There is significant variation in outcome reporting across RCTs of therapies for the prevention and treatment of FGR. The clinical applicability of future research would be enhanced by the development of a core outcome set for use in future trials.
Authors: Smriti Prasad; Erkan Kalafat; Helena Blakeway; Rosemary Townsend; Pat O'Brien; Edward Morris; Tim Draycott; Shakila Thangaratinam; Kirsty Le Doare; Shamez Ladhani; Peter von Dadelszen; Laura A Magee; Paul Heath; Asma Khalil Journal: Nat Commun Date: 2022-05-10 Impact factor: 17.694
Authors: C A Vollgraff Heidweiller-Schreurs; I R van Osch; M W Heymans; W Ganzevoort; L J Schoonmade; C J Bax; Bwj Mol; Cjm de Groot; Pmm Bossuyt; M A de Boer Journal: BJOG Date: 2020-06-08 Impact factor: 7.331