The TANGO-DM randomized controlled trial study protocol: treatment outcomes for gestational diabetes diagnosed according to WHO 2013 or WHO 1999 thresholds
BMC Pregnancy and Childbirth, vol. 25, pp. 173
Abstract
INTRODUCTION: Gestational diabetes mellitus (GDM), or hyperglycemia first diagnosed in pregnancy, affects 7-10% of all pregnancies worldwide. Perinatal risk rises with increasing glycemia at oral glucose tolerance test (OGTT). The new (2013) WHO criteria recommend a lower fasting, and a higher post-load threshold for GDM diagnosis in comparison to the old (1999) WHO criteria. To date, however, outcomes of GDM treatment for those affected by the altered diagnostic criteria, has not been well investigated. We hypothesized that intensive GDM treatment according to the new (2013) GDM criteria would result in a reduction in infants with birth weight > 90th centile (large for gestational age, LGA), in comparison to treatment according to the old criteria (1999). METHODS: The TANGO-DM trial is an open label, multicenter randomized controlled trial. Participants are pregnant with a gestational age between 16 + 0 and 32 + 0 weeks, who underwent a 1-step venous 2- or 3-point 75-gram oral OGTT, were eligible if they had glucose concentrations discordant between the old (1999) and the new (2013) criteria. After informed consent, women are randomized to either intensive GDM treatment, consisting of dietary advice and glucose monitoring and, if euglycemia is not reached, antihyperglycemic agents, or normal obstetric care without GDM treatment. The primary outcome is large-for-gestational-age infants (birth weight > 90th percentile). Secondary outcome measures include maternal complications, obstetric complications, neonatal complications, obstetric interventions, quality of life, and healthcare and societal costs. Outcomes will be analyzed according to the intention-to-treat principle. The study is powered to detect a reduction in LGA from 16% in the untreated to 10% in the treated group, which requires 1032 participants (516 per arm; alpha-error 5% for 80% power). DISCUSSION: The TANGO-DM trial will provide high-level evidence to support or refute the use of the new 2013 WHO diagnostic criteria in terms of their ability to lower the number of large for gestational age infants and/or improve maternal and perinatal outcomes and/or costs in women with gestational diabetes. TRIAL REGISTRATION: Central Committee on Research Involving Human Subjects (CCMO) (NL63013.018.18). Registered on 22 September 2018.
Authors 34
-
Doortje Rademaker corresponding
Amsterdam UMC Location University of Amsterdam · Amsterdam Reproduction Development
Affiliation as printed
Amsterdam Reproduction and Development Research Institute, Amsterdam, the Netherlands. d.rademaker@amsterdamumc.nl
Department of Obstetrics and Gynecology, Amsterdam UMC location University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands. d.rademaker@amsterdamumc.nl
Department of Obstetrics and Gynecology, Amsterdam UMC location University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands
-
Wilhelmina Children's Hospital
Affiliation as printed
Department of Obstetrics and Gynecology, WKZ, Lundlaan 6, Utrecht, 3584 EA, the Netherlands
-
Affiliation as printed
Department of Obstetrics and Gynecology, OLVG, Amsterdam, the Netherlands
-
Affiliation as printed
Department of Obstetrics and Gynecology, Tergooi MC, location Hilversum, Hilversum, the Netherlands
-
Affiliation as printed
Department of Obstetrics and Gynecology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands
-
Affiliation as printed
Department of Obstetrics and Gynecology, Meander Medical Center, Amersfoort, the Netherlands
-
Affiliation as printed
Department of Obstetrics and Gynecology, Division of Obstetrics and Fetal Medicine, Erasmus MC University Medical Center, Rotterdam, the Netherlands
-
Affiliation as printed
Department of Obstetrics and Gynecology, Tergooi MC, location Hilversum, Hilversum, the Netherlands
-
Affiliation as printed
Department of Obstetrics and Gynecology, Haga Hospital, The Hague, the Netherlands
-
Affiliation as printed
Department of Obstetrics and Gynecology, Gelre Hospitals, Apeldoorn, the Netherlands
-
Wilhelmina Children's Hospital
Affiliation as printed
Department of Obstetrics and Gynecology, WKZ, Lundlaan 6, Utrecht, 3584 EA, the Netherlands
-
Affiliation as printed
Department of Obstetrics and Gynecology, Flevoziekenhuis, Almere, the Netherlands
-
Affiliation as printed
Department of Obstetrics and Gynecology, Amphia hospital, Breda, the Netherlands
-
Affiliation as printed
Department of Obstetrics and Gynecology, Franciscus Gasthuis and Vlietland, Rotterdam, the Netherlands
-
Affiliation as printed
Department of Internal Medicine, Groene Hart Hospital, Gouda, the Netherlands
-
Affiliation as printed
Department of Obstetrics and Gynecology, Máxima Medical Center, Veldhoven, the Netherlands
-
Affiliation as printed
Department of Obstetrics and Gynecology, Spaarne Gasthuis, Haarlem, the Netherlands
-
Affiliation as printed
Department of Obstetrics and Gynecology, Noordwest hospital group, Alkmaar, the Netherlands
-
Affiliation as printed
Department of Obstetrics and Gynecology, Dijklander Hospital, Hoorn, the Netherlands
-
Affiliation as printed
Department of Obstetrics and Gynecology, Catharina Hospital, Eindhoven, the Netherlands
-
Affiliation as printed
Department of Obstetrics and Gynecology, Rijnstate Hospital, Arnhem, the Netherlands
-
Amsterdam University Medical Centers · Vrije Universiteit Amsterdam · Amsterdam UMC Location Vrije Universiteit Amsterdam
Affiliation as printed
Department of Obstetrics and Gynecology, Amsterdam UMC location Vrije Universiteit, Boelelaan, Amsterdam, 1117, the Netherlands
-
Affiliation as printed
Department of Obstetrics and Gynecology, Deventer Hospital, Deventer, the Netherlands
-
Amsterdam Public Health · Vrije Universiteit Amsterdam
Affiliation as printed
Department of Health Sciences, Faculty of Earth and Life Sciences, EMGO+ Institute for Health and Care Research, VU University Amsterdam, Amsterdam, the Netherlands
-
Amsterdam Public Health · Amsterdam University Medical Centers · University of Amsterdam
Affiliation as printed
Department of Epidemiology & Data Science, Amsterdam Public Health, Amsterdam University Medical Centres, University of Amsterdam, Amsterdam, the Netherlands
-
Amsterdam UMC Location University of Amsterdam
Affiliation as printed
Department of Obstetrics and Gynecology, Amsterdam UMC location University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands
-
Leiden University · Leiden University Medical Center
Affiliation as printed
Division of Neonatology, Leiden University Medical Centre, Leiden, The Netherlands
-
Amsterdam UMC Location University of Amsterdam
Affiliation as printed
Department of Obstetrics and Gynecology, Amsterdam UMC location University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands
-
University Medical Center Groningen · University of Nottingham · University of Groningen · Amsterdam UMC Location University of Amsterdam · Amsterdam Public Health · Máxima Medisch Centrum · Amsterdam UMC Location Vrije Universiteit Amsterdam
Affiliation as printed
Amsterdam Public Health research institute, Quality of Care, Amsterdam, Netherlands
Amsterdam UMC location Vrije Universiteit Amsterdam, Midwifery Science, De Boelelaan 1117, Amsterdam, the Netherlands
Department of Obstetrics and Gynecology, Amsterdam UMC location University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands
Department of Obstetrics and Gynecology, Máxima Medical Center, Veldhoven, the Netherlands
Department of Primary and Long Term Care, University of Groningen, University Medical Center Groningen, Groningen, Netherlands
Division of Midwifery, School of Health Sciences, University of Nottingham, Nottingham, UK
Midwifery Academy Amsterdam Groningen, Inholland, Amsterdam, Netherlands
-
University of Aberdeen · Monash University
Affiliation as printed
Aberdeen Centre for Women's Health Research, Institute of Applied Health Sciences, School of Medicine, Medical Sciences, and Nutrition, University of Aberdeen, Aberdeen, Scotland
Department of Obstetrics and Gynecology, Monash University, Clayton, VIC, Australia
-
Affiliation as printed
Department of Obstetrics and Gynecology, Meander Medical Center, Amersfoort, the Netherlands
-
Amsterdam UMC Location University of Amsterdam
Affiliation as printed
Department of Internal Medicine, Amsterdam UMC location University of Amsterdam, Meibergdreef 9, Amsterdam, the Netherlands
-
Affiliation as printed
Department of Obstetrics and Gynecology, Máxima Medical Center, Veldhoven, the Netherlands
-
Erasmus MC · Amsterdam University Medical Centers · Vrije Universiteit Amsterdam · Amsterdam UMC Location Vrije Universiteit Amsterdam
Affiliation as printed
Department of Obstetrics and Gynecology, Amsterdam UMC location Vrije Universiteit, Boelelaan, Amsterdam, 1117, the Netherlands
Department of Obstetrics and Gynecology, Division of Obstetrics and Fetal Medicine, Erasmus MC University Medical Center, Rotterdam, the Netherlands
Cited by 0 stored of 0
No patents citing this paper on Lens.org (checked 2026-10-11).