Back to resultsThe Best Timing of Delivery in Women With GDM Study
Primary Purpose
Gestational Diabetes, Induction of Labor Affected Fetus / Newborn
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
New procedure
Sponsored by
About this trial
This is an interventional treatment trial for Gestational Diabetes focused on measuring induction, caesarean section, fetal weight, Bishop score
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.
Sites / Locations
- Peking University First HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
old guideline group
new procedure group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
caesarean section rate
Secondary Outcome Measures
mode of delivery
spontaneous or operative vaginal delivery, caesarean section；the investigator will use questionnaire to collect these information from their medical record
onset of labour
spontaneous or instrumental third stage of labour, planned or emergency caesarean section;the investigator will use questionnaire to collect these information
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
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
method of induction of labour
prostaglandin tablet regime; artificial rupture of amniotic membranes; oxytocin exclusive if used to accelerate normal labour
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
gestational age
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
birth weight
neonatal sex
neonatal plasma glucose level collected 1-2h after delivery
neonatal hypoglycemia
stillbirth
a baby delivered with no signs of life after24 completed weeks of pregnancy
shoulder dystocia
the investigator will use questionnaire to collect these information from their medical record
death before discharge from hospital
Apgar at 1 min, Apgar at 5 min, Apgar at 10 minutes
cord blood artery pH
neonatal respiratory distress
the investigator will use questionnaire to collect these information from their medical record
birth trauma
subdural haematoma, intracerebral or intraventricular haemorrhage, spinal-cord injury, basal skull fracture, peripheral-nerve injury, long bone fracture
NICU admission
seizures
the investigator will use questionnaire to collect these information from their medical record
hypotonia
the investigator will use questionnaire to collect these information from their medical record
intubation and ventilation for > 24 h
oxygen required
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
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)
rate of labor pain
Full Information
NCT ID
NCT03928899
First Posted
April 18, 2019
Last Updated
September 23, 2021
Sponsor
Peking University First Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03928899
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Induction of Labor Affected Fetus / Newborn
Keywords
induction, caesarean section, fetal weight, Bishop score
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
old guideline group
Arm Type
No Intervention
Arm Description
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.
Arm Title
new procedure group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
New procedure
Other Intervention Name(s)
New
Intervention Description
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.
Primary Outcome Measure Information:
Title
caesarean section rate
Time Frame
41weeks
Secondary Outcome Measure Information:
Title
mode of delivery
Description
spontaneous or operative vaginal delivery, caesarean section；the investigator will use questionnaire to collect these information from their medical record
Time Frame
41weeks
Title
onset of labour
Description
spontaneous or instrumental third stage of labour, planned or emergency caesarean section;the investigator will use questionnaire to collect these information
Time Frame
41weeks
Title
operative vaginal delivery indication
Description
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
Time Frame
41weeks
Title
caesarean section indication
Description
induction failed; chorioamnionitis defined as a clinical diagnosis before delivery; fetal distress; arrest of second stage of labour; failed instrumental delivery; maternal complication; elective
Time Frame
41weeks
Title
method of induction of labour
Description
prostaglandin tablet regime; artificial rupture of amniotic membranes; oxytocin exclusive if used to accelerate normal labour
Time Frame
41weeks
Title
indication for induction
Description
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
Time Frame
41weeks
Title
gestational age
Time Frame
41weeks
Title
intrapartum complications
Description
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
Time Frame
41weeks
Title
birth weight
Time Frame
41weeks
Title
neonatal sex
Time Frame
41weeks
Title
neonatal plasma glucose level collected 1-2h after delivery
Time Frame
41weeks
Title
neonatal hypoglycemia
Time Frame
41weeks
Title
stillbirth
Description
a baby delivered with no signs of life after24 completed weeks of pregnancy
Time Frame
41weeks
Title
shoulder dystocia
Description
the investigator will use questionnaire to collect these information from their medical record
Time Frame
41weeks
Title
death before discharge from hospital
Time Frame
41weeks
Title
Apgar at 1 min, Apgar at 5 min, Apgar at 10 minutes
Time Frame
41weeks
Title
cord blood artery pH
Time Frame
41weeks
Title
neonatal respiratory distress
Description
the investigator will use questionnaire to collect these information from their medical record
Time Frame
41weeks
Title
birth trauma
Description
subdural haematoma, intracerebral or intraventricular haemorrhage, spinal-cord injury, basal skull fracture, peripheral-nerve injury, long bone fracture
Time Frame
41weeks
Title
NICU admission
Time Frame
41weeks
Title
seizures
Description
the investigator will use questionnaire to collect these information from their medical record
Time Frame
41weeks
Title
hypotonia
Description
the investigator will use questionnaire to collect these information from their medical record
Time Frame
41weeks
Title
intubation and ventilation for > 24 h
Time Frame
41weeks
Title
oxygen required
Time Frame
41weeks
Title
the utilization of medical resources
Description
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
Time Frame
41weeks
Title
the mothers' expectations and experience of childbirth
Description
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)
Time Frame
41weeks
Title
rate of labor pain
Time Frame
41weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Wang
Phone
18518079870
Email
wangchenpku@bjmu.edu.cn
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yumei Wei, MD
Phone
+8618601369529
Email
Weiyumei1982@126.com
First Name & Middle Initial & Last Name & Degree
Chen Wang
Phone
+8618518079870
Email
kisskissy22@126.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Best Timing of Delivery in Women With GDM Study
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