Clinical trial NCT03928899: The Best Timing of Delivery in Women With GDM Study
Official title: The Best Timing of Delivery in Women With GDM That is Controlled With Only Diet and Exercise
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes
Induction of Labor Affected Fetus / Newborn
Keywords: induction
caesarean section
fetal weight
Bishop score
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 230
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* known HIV positivity because of modified delivery plan
* signs of labor (regular painful contractions with cervical change) before 37weeks 6 days of gestation.

Primary outcomes:
measure: caesarean section rate
timeFrame: 41weeks
Secondary outcomes:
measure: mode of delivery
timeFrame: 41weeks
measure: onset of labour
timeFrame: 41weeks
measure: operative vaginal delivery indication
timeFrame: 41weeks
measure: caesarean section indication
timeFrame: 41weeks
measure: method of induction of labour
timeFrame: 41weeks
measure: indication for induction
timeFrame: 41weeks
measure: gestational age
timeFrame: 41weeks
measure: intrapartum complications
timeFrame: 41weeks
measure: birth weight
timeFrame: 41weeks
measure: neonatal sex
timeFrame: 41weeks
measure: neonatal plasma glucose level collected 1-2h after delivery
timeFrame: 41weeks
measure: neonatal hypoglycemia
timeFrame: 41weeks
measure: stillbirth
timeFrame: 41weeks
measure: shoulder dystocia
timeFrame: 41weeks
measure: death before discharge from hospital
timeFrame: 41weeks
measure: Apgar at 1 min, Apgar at 5 min, Apgar at 10 minutes
timeFrame: 41weeks
measure: cord blood artery pH
timeFrame: 41weeks
measure: neonatal respiratory distress
timeFrame: 41weeks
measure: birth trauma
timeFrame: 41weeks
measure: NICU admission
timeFrame: 41weeks
measure: seizures
timeFrame: 41weeks
measure: hypotonia
timeFrame: 41weeks
measure: intubation and ventilation for > 24 h
timeFrame: 41weeks
measure: oxygen required
timeFrame: 41weeks
measure: the utilization of medical resources
timeFrame: 41weeks
measure: the mothers' expectations and experience of childbirth
timeFrame: 41weeks
measure: rate of labor pain
timeFrame: 41weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
References: