Gestational diabetes well controlled on medical nutritional therapy: a randomized trial of active induction of labour compared with expectant management
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Caesarean section
研究概览
简要总结
GDM is one of the most common complications of pregnancy and itsincidence is estimated at 7% (1). Among women affected by GDM, anincreased rate of C-section has been observed (2)(3). Expectant monitoring could determine an increase in macrosomic fetuses’incidence, leading to a higher C-section rate. Although induction of labourcould prevent fetal macrosomia and its consequences, its performance is thoughtto be possibly related to an enhancement in C-section and instrumental vaginaldelivery rates (4).
Strong evidence, based on adequately designedprospective studies and randomized controlled trials, in favour or against theeffectiveness and safeness of induction in women with GDM are missing (1)(5). In light of this clinical situation, randomized controlled trialcomparing induction of labour at term to careful expectant monitoring is needed
The present trial will provide evidence as to whetheror not, in women affected by gestational Diabetes on MNT, expectant managementtill 41 weeks is an effective management to ameliorate maternal and neonataloutcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •â€¢Maternal age ≥ 18 years •Willing for delivery at CMC, Vellore •Singleton pregnancy in vertex presentation •Gestational age between 39+ and 40 weeks, by LMP sure of dates or by early scan •Women diagnosed with GDM on diet therapy well controlled (AC <95, PC 1 hr.
- •<140) in the present pregnancy •No contraindications to vaginal delivery.
排除标准
- •â€¢Pregestational diabetes •GDM diagnosed elsewhere •GDM diagnosis not based on IADPGS recommendation •GDM on OHA, Insulin or not under control(AC >95, PC 1 hr.
- •>140) •Women not willing for delivery at CMC, Vellore •Prior C-section •Suspected estimated fetal weight > 3.5 kg or < 2.5 kg at enrolment •Any known contraindications to vaginal delivery •Uncertain gestational age •Non reassuring fetal wellbeing necessitating delivery •Maternal pregnancy-related disease necessitating delivery •Known fetal anomaly.
结局指标
主要结局
Caesarean section
时间窗: At the time of delivery
次要结局
- Maternal(•Need for maternal blood transfusion)