The Best Timing of Delivery in Women With GDM Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Best Timing of Delivery in Women With GDM That is Controlled With Only Diet and Exercise

Conditions
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Gestational Diabetes, Induction of Labor Affected Fetus / Newborn

Intervention / Treatment
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* Procedure: New procedure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: old guideline group<br>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. | |
| Experimental: new procedure group<br>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. | Procedure: New procedure<br>* An optimal management on the timing and mode of delivery of pregnant women with GDM, by a comprehensive assessment and consideration of their fetal weight, gestational age, and cervical ripeness.<br>* Other names: New;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| caesarean section rate |  | 41weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mode of delivery | spontaneous or operative vaginal delivery, caesarean section；the investigator will use questionnaire to collect these information from their medical record | 41weeks | 
| onset of labour | spontaneous or instrumental third stage of labour, planned or emergency caesarean section;the investigator will use questionnaire to collect these information | 41weeks | 
| operative vaginal delivery indication | 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 | 41weeks | 
| caesarean section indication | induction failed; chorioamnionitis defined as a clinical diagnosis before delivery; fetal distress; arrest of second stage of labour; failed instrumental delivery; maternal complication; elective | 41weeks | 
| method of induction of labour | prostaglandin tablet regime; artificial rupture of amniotic membranes; oxytocin exclusive if used to accelerate normal labour | 41weeks | 
| indication for induction | 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 | 41weeks | 
| gestational age |  | 41weeks | 
| intrapartum complications | 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 | 41weeks | 
| birth weight |  | 41weeks | 
| neonatal sex |  | 41weeks | 
| neonatal plasma glucose level collected 1-2h after delivery |  | 41weeks | 
| neonatal hypoglycemia |  | 41weeks | 
| stillbirth | a baby delivered with no signs of life after24 completed weeks of pregnancy | 41weeks | 
| shoulder dystocia | the investigator will use questionnaire to collect these information from their medical record | 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 | 
| neonatal respiratory distress | the investigator will use questionnaire to collect these information from their medical record | 41weeks | 
| birth trauma | subdural haematoma, intracerebral or intraventricular haemorrhage, spinal-cord injury, basal skull fracture, peripheral-nerve injury, long bone fracture | 41weeks | 
| NICU admission |  | 41weeks | 
| seizures | the investigator will use questionnaire to collect these information from their medical record | 41weeks | 
| hypotonia | the investigator will use questionnaire to collect these information from their medical record | 41weeks | 
| intubation and ventilation for > 24 h |  | 41weeks | 
| oxygen required |  | 41weeks | 
| the utilization of medical resources | 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 | 41weeks | 
| the mothers' expectations and experience of childbirth | 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) | 41weeks | 
| rate of labor pain |  | 41weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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induction, caesarean section, fetal weight, Bishop score