The Best Timing of Delivery in Women With GDM Study

Not Applicable

• Conditions: Induction of Labor Affected Fetus / Newborn; Gestational Diabetes

• 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.

Study Timeline

• Study First Submitted: 2019-04-18
• Study First Submitted QC: 2019-04-23
• Study First Posted: 2019-04-26
• Study Start: 2019-07-15
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-27
• Primary Completion: 2022-05-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 230

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
caesarean section rate	41weeks

Secondary Outcome Measures

Name	Time	Method
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
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
stillbirth	41weeks	a baby delivered with no signs of life after24 completed weeks of pregnancy
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
neonatal hypoglycemia	41weeks
neonatal sex	41weeks

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China