Gestational Diabetes Clinical Trial
Official title:
GINEXMAL RCT: Induction of Labour Versus Expectant Management in Gestational Diabetes Pregnancies
The purpose of this study is to determine whether, in Gestational Diabetes Mellitus (GDM) pregnancies, induction of labour at 38-39 weeks of pregnancy is superior to expectant management in terms of maternal and neonatal outcomes.
Gestational Diabetes Mellitus (GDM) is one of the most common complications of pregnancy and
its incidence is estimated as around 7%. Babies born from women with GDM are significantly
more exposed to perinatal risk. Furthermore in GDM pregnancies an increased C-section rate
has been observed, mostly unjustified.
Strong evidence, based on prospective studies and randomized controlled trials, in favour or
against the effectiveness and safeness of induction in women with GDM, are missing. The aim
of the present study is to identify the best management for these women at term and provide
evidence that could change the current clinical practice.
To reach this objective, 1760 eligible women will be recruited at 9 Teaching Hospitals (5 in
Italy, 4 all over the world). Sample size has been estimated to demonstrate a difference
between the two arms ≥ 6% (31% of C-section in the expectant group and 25% in the induction
group; relative difference between the 2 groups equal to 20% in favor of induction; Kjos et
al, 1993), considering an α error equal to 5% and 80% power.
Patients will be randomized to induction of labour (N=880) or expectant management (N=880).
Data on maternal and neonatal outcomes will be collected at delivery and until maternal and
neonatal discharge.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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