The Best Timing of Delivery in Women With GDM That is Controlled With Only Diet and Exercise
试验速览
- 阶段
- 不适用
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- caesarean section rate
研究概览
简要总结
The investigatiors aimed to conduct a well-designed RCT to firstly focus on GDM women controlled with only diet and exercise, and provide an optimize process on their timing and mode of delivery
详细描述
GDM is a common complication of pregnancy and even mildly hyperglycemia could significantly affect fetal growth. Optimal delivery timing in women with GDM remains controversial. This decision process involves balancing the potential for complications that are caused by increased interventions with the benefit of avoidance of future adverse outcomes. Thus, the aim of the present trial is to explore the best management on the timing of delivery of pregnant women with GDM that controlled with only diet and exercise, which can both decrease the risk of macrosomia and the risk of cesarean delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •singleton pregnant women
- •in vertex presentation
- •GDM that is controlled with only diet and exercise
- •at 37 weeks 0 days to 37 weeks 6 days of gestation
- •more than 18 years old
- •have no other contraindications to vaginal delivery.
排除标准
- •prior caesarean section or myomectomy
- •any known contraindications to vaginal delivery
- •uncertain gestational age
- •non reassuring foetal wellbeing necessitating delivery
- •maternal pregnancy-related disease necessitating delivery (any hypertensive disorder, cardiac disease, renal insufficiency、immune diseases, et al.)
- •placenta previa, accreta, vasa previa
- •known foetal anomaly
- •negative reproductive history
- •ruptured membranes or known oligohydramnios (defined as AFI < 5 or MVP < 2 ) before 37weeks 6 days of gestation
- •fetal growth restriction, defined as EFW < 10th percentile
- •known HIV positivity because of modified delivery plan
- •signs of labor (regular painful contractions with cervical change) before 37weeks 6 days of gestation.
研究组 & 干预措施
old guideline group
Women randomized to the "old guideline group" will be followed up once-weekly by electronic fetal heart rate monitoring and biophysical profile until 40 weeks 0 days (unless a medical indication arises), when induction of labor was then offered.
new procedure group
Women randomized to "new procedure group" will first undergo fetal weight ultrasound estimation at 38 weeks 0 days to 38 weeks 6 days of gestation, if the fetus is estimated to be LGA/macrosomia by ultrasound, women should have an elective induction of labor immediately (at 38 weeks 0 days to 38 weeks 6 days of gestation). On the contrary, if the fetus is estimated to be normal size, the pregnant women were then given a cervical assessment. If the Bishop score ≥6, women will have at least weekly follow-up visits with their doctors and unless a medical indication is present, continue pregnancy and have selective induction at 40 weeks 0 days of gestation. Whereas, if the Bishop score <6, women will be followed up until 41 weeks 0 days of gestation with a close assessment of fetal wellbeing through the cardiotocographic trace. And women who will not deliver by this gestational age will be admitted for labor induction. Certainly, medical indication should warrant delivery without delay.
干预措施: New procedure (Procedure)
结局指标
主要结局
caesarean section rate
时间窗: 41weeks
次要结局
- neonatal hypoglycemia(41weeks)
- mode of delivery(41weeks)
- operative vaginal delivery indication(41weeks)
- method of induction of labour(41weeks)
- indication for induction(41weeks)
- oxygen required(41weeks)
- rate of labor pain(41weeks)
- intrapartum complications(41weeks)
- neonatal plasma glucose level collected 1-2h after delivery(41weeks)
- death before discharge from hospital(41weeks)
- Apgar at 1 min, Apgar at 5 min, Apgar at 10 minutes(41weeks)
- cord blood artery pH(41weeks)
- hypotonia(41weeks)
- neonatal sex(41weeks)
- stillbirth(41weeks)
- neonatal respiratory distress(41weeks)
- the mothers' expectations and experience of childbirth(41weeks)
- onset of labour(41weeks)
- shoulder dystocia(41weeks)
- birth trauma(41weeks)
- caesarean section indication(41weeks)
- gestational age(41weeks)
- birth weight(41weeks)
- NICU admission(41weeks)
- seizures(41weeks)
- intubation and ventilation for > 24 h(41weeks)
- the utilization of medical resources(41weeks)
研究者
Wang Chen
Doctor
Peking University First Hospital