GINEXMAL RCT: Induction of Labour Versus Expectant Management in Gestational Diabetes Pregnancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 425
- 试验地点
- 18
- 主要终点
- C-section rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Maternal age > 18;
- •Singleton pregnancy in vertex presentation;
- •Gestational age between 38-39 weeks verified by LMP and first trimester ultrasound when available;
- •Women diagnosed with GDM in the current pregnancy [Diagnosis will be based upon abnormal 50 Gr. GCT (>140) followed by >2 abnormal indices in the OGTT (according to C&C criteria). Women with GCT>200 mg/dl will undergo 100 gr OGTT as well];
- •No other contraindications for vaginal delivery.
排除标准
- •Pre-gestational diabetes;
- •Prior C-section;
- •Suspected estimated fetal weight> 4000 gr. at enrollment;
- •Any known contraindications for vaginal delivery;
- •Uncertain gestational age;
- •Non-reassuring fetal status necessitating immediate obstetrical intervention (prompt delivery/prompt C-section);
- •Maternal disease complicating pregnancy and necessitating delivery (e.g Severe PET);
- •Bishop score >7 at enrollment;
- •Major fetal malformation.
结局指标
主要结局
C-section rate
时间窗: 1 minute after delivery
次要结局
- Operative Vaginal Delivery(1 minute after delivery)
- Perineal Tears or Episiotomy(1 minute after delivery)
- Postpartum haemorrhage(within 24 hours from delivery)
- Maternal Blood Transfusion(until maternal discharge)
- Maternal Intensive Care Unit Admission(until maternal discharge)
- Neonatal Weight(10 minutes after delivery)
- Neonatal Apgar score at 1', 5', 10' minutes(1, 5, 10 minutes after delivery)
- Shoulder Dystocia(during delivery)
- Manoeuvres for Shoulder Dystocia(during delivery)
- Neonatal Intensive Care Unit Admission(until neonatal discharge)
- Arterial cord Ph inferior to 7.2(within 5 minutes from delivery)
- Neonatal Hyperbilirubinemia(until neonatal discharge)
- Clinical and Biochemical Neonatal Hypoglycemia(until neonatal discharge)
- Neonatal Polycythemia(until neonatal discharge)
- Neonatal Birth Trauma(10 minute from delivery or until neonatal discharge)
- Neonatal Respiratory Distress/Transient Tachypnea(until neonatal discharge)
- Neonatal Need for Respiratory Support(until neonatal discharge)
- Maternal death(until neonatal discharge)
- Perinatal Death(until neonatal discharge)
- Spontaneous/Instrumental third stage of labour(within 1 hours from delivery)
- Indication for Cesarean Section(1 minutes after delivery)
研究者
Ronfani Luca
Dr
IRCCS Burlo Garofolo