NCT01058772

Gestational Diabetes: Induction Versus Expectant Management of Labour

GINEXMAL RCT: Induction of Labour Versus Expectant Management in Gestational Diabetes Pregnancies

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 425 (actual)
• Sponsor: IRCCS Burlo Garofolo · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gestational Diabetes
• Gestational Diabetes Mellitus
• Diabetes Mellitus, Gestational
• Pregnancy-Induced Diabetes
• Diabetes, Pregnancy Induced

Interventions

Type	Name	Description
OTHER	INDUCTION of LABOUR	Induction of labour will be performed by using dinoprostone 2 mg vaginally or dinoprostone 0.5 mg intracervically at 6-8h interval (up to 5 doses) or dinoprostone 10 mg vaginal device. Patients, in which cervical ripening does not occur (Bishop score \< 7) after 5 attempts with PGE2, will be offered either oxytocin or Foley catheter induction or C-section, according to local protocols.

Timeline

• Start date: 2010-03-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2010-01-29
• Last updated: 2015-04-30

Locations

9 sites across 5 countries: Israel, Italy, Netherlands, Slovenia, Sri Lanka