The Best Timing of Delivery in Women With GDM Study
- Conditions
- Induction of Labor Affected Fetus / NewbornGestational Diabetes
- Interventions
- Procedure: New procedure
- Registration Number
- NCT03928899
- Lead Sponsor
- Peking University First Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 230
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description new procedure group New procedure 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.
- Primary Outcome Measures
Name Time Method caesarean section rate 41weeks
- Secondary Outcome Measures
Name Time Method stillbirth 41weeks a baby delivered with no signs of life after24 completed weeks of pregnancy
oxygen required 41weeks rate of labor pain 41weeks intrapartum complications 41weeks placental abruption; cord prolapse; postpartum haemorrhage defined as bleeding of 500/1000ml or more in the first 24 hours following the vaginal/ caesarean section delivery of the baby; third or fourth degree perineal laceration; admission to intensive care unit; hysterectomy; maternal venous thromboembolism
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 the investigator will use questionnaire to collect these information from their medical record
mode of delivery 41weeks spontaneous or operative vaginal delivery, caesarean section；the investigator will use questionnaire to collect these information from their medical record
operative vaginal delivery indication 41weeks chorioamnionitis defined as a clinical diagnosis before delivery; fetal distress; arrest of second stage of labour; maternal complicatio;the investigator will use questionnaire to collect these information from their medical record
method of induction of labour 41weeks prostaglandin tablet regime; artificial rupture of amniotic membranes; oxytocin exclusive if used to accelerate normal labour
indication for induction 41weeks randomised to treatment; prelabour rupture of membranes \> 2 hours and no regular contractions; fetal growth restriction; reduced fetal movements/suspected fetal distress; pregnancy induced hypertension; pre-eclampsia/eclampsia; obstetric cholestasis;the investigator will use questionnaire to collect these information from their medical record
neonatal sex 41weeks neonatal respiratory distress 41weeks the investigator will use questionnaire to collect these information from their medical record
the mothers' expectations and experience of childbirth 41weeks measured by the Labour Agentry Scale (which is designed to assess the expectations and experiences of personal control during childbirth, with higher scores indicating greater perceived control during childbirth)
onset of labour 41weeks spontaneous or instrumental third stage of labour, planned or emergency caesarean section;the investigator will use questionnaire to collect these information
shoulder dystocia 41weeks the investigator will use questionnaire to collect these information from their medical record
birth trauma 41weeks subdural haematoma, intracerebral or intraventricular haemorrhage, spinal-cord injury, basal skull fracture, peripheral-nerve injury, long bone fracture
caesarean section indication 41weeks induction failed; chorioamnionitis defined as a clinical diagnosis before delivery; fetal distress; arrest of second stage of labour; failed instrumental delivery; maternal complication; elective
gestational age 41weeks birth weight 41weeks NICU admission 41weeks seizures 41weeks the investigator will use questionnaire to collect these information from their medical record
intubation and ventilation for > 24 h 41weeks the utilization of medical resources 41weeks That includes: number of clinic visits post randomization to admission for delivery, number of times for having non-stress tests, ultrasounds and contraction stress tests, Use of induction and ripening agents, maximum dose of oxytocin, interval from randomization to delivery, number of hours on the labor and delivery unit, maternal postpartum length of hospital stay, neonatal length of hospital stay
Trial Locations
- Locations (1)
Peking University First Hospital
🇨🇳Beijing, Beijing, China