The Best Timing of Delivery in Women With GDM That is Controlled With Only Diet and Exercise
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gestational Diabetes
- Sponsor
- Peking University First Hospital
- Enrollment
- 230
- Locations
- 1
- Primary Endpoint
- caesarean section rate
- Last Updated
- 4 years ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Wang Chen
Doctor
Peking University First Hospital
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
caesarean section rate
Time Frame: 41weeks
Secondary Outcomes
- oxygen required(41weeks)
- rate of labor pain(41weeks)
- intrapartum complications(41weeks)
- neonatal plasma glucose level collected 1-2h after delivery(41weeks)
- neonatal hypoglycemia(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)
- mode of delivery(41weeks)
- operative vaginal delivery indication(41weeks)
- method of induction of labour(41weeks)
- indication for induction(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)