TY - JOUR
T1 - The TANGO-DM randomized controlled trial study protocol
T2 - treatment outcomes for gestational diabetes diagnosed according to WHO 2013 or WHO 1999 thresholds
AU - Rademaker, Doortje
AU - de Wit, Leon
AU - van der Wel, Anne
AU - van den Akker, Eline
AU - Braams-Lisman, Babette
AU - Dullemond, Remke
AU - Evers, Inge
AU - Galjaard, Sander
AU - Hermsen, Brenda
AU - van Hoorn, Marion
AU - Huisjes, Anjoke
AU - Kaandorp, Joepe
AU - Lub, Annemiek
AU - Lunshof, Simone
AU - van der Made, Flip
AU - Nijman, Remco
AU - van Laar, Judith
AU - Vollebregt, Karlijn
AU - Velzel, Joost
AU - Vlemmix, Floortje
AU - Westerhuis, Michelle
AU - Wijnberger, Lia
AU - Wouters, Maurice
AU - Zwart, Joost
AU - Bosmans, Judith
AU - Bossuyt, Patrick
AU - Duijnhoven, Ruben
AU - Lopriore, Enrico
AU - de Miranda, Esteriek
AU - Verhoeven, Corine
AU - Mol, Ben Willem
AU - Franx, Arie
AU - DeVries, J. Hans
AU - van Rijn, Bas
AU - Painter, Rebecca
N1 - Publisher Copyright:
© The Author(s) 2025.
PY - 2025/12
Y1 - 2025/12
N2 - 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.
AB - 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.
KW - Gestational diabetes mellitus
KW - IADPSG
KW - Large-for-gestational-age
KW - Randomized controlled trial
KW - WHO 1999
UR - https://www.scopus.com/pages/publications/85218949161
U2 - 10.1186/s12884-025-07230-x
DO - 10.1186/s12884-025-07230-x
M3 - Article
C2 - 39962444
SN - 1471-2393
VL - 25
SP - 173
JO - BMC pregnancy and childbirth
JF - BMC pregnancy and childbirth
IS - 1
M1 - 173
ER -
