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出境医 / 临床实验 / The Best Timing of Delivery in Women With GDM Study

The Best Timing of Delivery in Women With GDM Study

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

Condition or disease Intervention/treatment Phase
Gestational Diabetes Induction of Labor Affected Fetus / Newborn Procedure: New procedure Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Best Timing of Delivery in Women With GDM That is Controlled With Only Diet and Exercise
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Arm Intervention/treatment
No Intervention: old guideline group
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
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
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.
Other Name: New
Outcome Measures
Primary Outcome Measures :
  1. caesarean section rate [ Time Frame: 41weeks ]

Secondary Outcome Measures :
  1. mode of delivery [ Time Frame: 41weeks ]
    spontaneous or operative vaginal delivery, caesarean section；the investigator will use questionnaire to collect these information from their medical record

  2. onset of labour [ Time Frame: 41weeks ]
    spontaneous or instrumental third stage of labour, planned or emergency caesarean section;the investigator will use questionnaire to collect these information

  3. operative vaginal delivery indication [ Time Frame: 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

  4. caesarean section indication [ Time Frame: 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

  5. method of induction of labour [ Time Frame: 41weeks ]
    prostaglandin tablet regime; artificial rupture of amniotic membranes; oxytocin exclusive if used to accelerate normal labour

  6. indication for induction [ Time Frame: 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

  7. gestational age [ Time Frame: 41weeks ]
  8. intrapartum complications [ Time Frame: 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

  9. birth weight [ Time Frame: 41weeks ]
  10. neonatal sex [ Time Frame: 41weeks ]
  11. neonatal plasma glucose level collected 1-2h after delivery [ Time Frame: 41weeks ]
  12. neonatal hypoglycemia [ Time Frame: 41weeks ]
  13. stillbirth [ Time Frame: 41weeks ]
    a baby delivered with no signs of life after24 completed weeks of pregnancy

  14. shoulder dystocia [ Time Frame: 41weeks ]
    the investigator will use questionnaire to collect these information from their medical record

  15. death before discharge from hospital [ Time Frame: 41weeks ]
  16. Apgar at 1 min, Apgar at 5 min, Apgar at 10 minutes [ Time Frame: 41weeks ]
  17. cord blood artery pH [ Time Frame: 41weeks ]
  18. neonatal respiratory distress [ Time Frame: 41weeks ]
    the investigator will use questionnaire to collect these information from their medical record

  19. birth trauma [ Time Frame: 41weeks ]
    subdural haematoma, intracerebral or intraventricular haemorrhage, spinal-cord injury, basal skull fracture, peripheral-nerve injury, long bone fracture

  20. NICU admission [ Time Frame: 41weeks ]
  21. seizures [ Time Frame: 41weeks ]
    the investigator will use questionnaire to collect these information from their medical record

  22. hypotonia [ Time Frame: 41weeks ]
    the investigator will use questionnaire to collect these information from their medical record

  23. intubation and ventilation for > 24 h [ Time Frame: 41weeks ]
  24. oxygen required [ Time Frame: 41weeks ]
  25. the utilization of medical resources [ Time Frame: 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

  26. the mothers' expectations and experience of childbirth [ Time Frame: 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)

  27. rate of labor pain [ Time Frame: 41weeks ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Chen Wang 18518079870 wangchenpku@bjmu.edu.cn

Locations
Layout table for location information
China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Yumei Wei, MD    +8618601369529    Weiyumei1982@126.com   
Contact: Chen Wang    +8618518079870    kisskissy22@126.com   
Sponsors and Collaborators
Peking University First Hospital
Tracking Information
First Submitted Date  ICMJE April 18, 2019
First Posted Date  ICMJE April 26, 2019
Last Update Posted Date September 19, 2019
Actual Study Start Date  ICMJE July 15, 2019
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019) 		caesarean section rate [ Time Frame: 41weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • mode of delivery [ Time Frame: 41weeks ]
    spontaneous or operative vaginal delivery, caesarean section；the investigator will use questionnaire to collect these information from their medical record
  • onset of labour [ Time Frame: 41weeks ]
    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 [ Time Frame: 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
  • caesarean section indication [ Time Frame: 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
  • method of induction of labour [ Time Frame: 41weeks ]
    prostaglandin tablet regime; artificial rupture of amniotic membranes; oxytocin exclusive if used to accelerate normal labour
  • indication for induction [ Time Frame: 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
  • gestational age [ Time Frame: 41weeks ]
  • intrapartum complications [ Time Frame: 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
  • birth weight [ Time Frame: 41weeks ]
  • neonatal sex [ Time Frame: 41weeks ]
  • neonatal plasma glucose level collected 1-2h after delivery [ Time Frame: 41weeks ]
  • neonatal hypoglycemia [ Time Frame: 41weeks ]
  • stillbirth [ Time Frame: 41weeks ]
    a baby delivered with no signs of life after24 completed weeks of pregnancy
  • shoulder dystocia [ Time Frame: 41weeks ]
    the investigator will use questionnaire to collect these information from their medical record
  • death before discharge from hospital [ Time Frame: 41weeks ]
  • Apgar at 1 min, Apgar at 5 min, Apgar at 10 minutes [ Time Frame: 41weeks ]
  • cord blood artery pH [ Time Frame: 41weeks ]
  • neonatal respiratory distress [ Time Frame: 41weeks ]
    the investigator will use questionnaire to collect these information from their medical record
  • birth trauma [ Time Frame: 41weeks ]
    subdural haematoma, intracerebral or intraventricular haemorrhage, spinal-cord injury, basal skull fracture, peripheral-nerve injury, long bone fracture
  • NICU admission [ Time Frame: 41weeks ]
  • seizures [ Time Frame: 41weeks ]
    the investigator will use questionnaire to collect these information from their medical record
  • hypotonia [ Time Frame: 41weeks ]
    the investigator will use questionnaire to collect these information from their medical record
  • intubation and ventilation for > 24 h [ Time Frame: 41weeks ]
  • oxygen required [ Time Frame: 41weeks ]
  • the utilization of medical resources [ Time Frame: 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
  • the mothers' expectations and experience of childbirth [ Time Frame: 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)
  • rate of labor pain [ Time Frame: 41weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Best Timing of Delivery in Women With GDM Study
Official Title  ICMJE The Best Timing of Delivery in Women With GDM That is Controlled With Only Diet and Exercise
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gestational Diabetes
  • Induction of Labor Affected Fetus / Newborn
Intervention  ICMJE Procedure: New procedure
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.
Other Name: New
Study Arms  ICMJE
  • No Intervention: old guideline group
    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
    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: Procedure: New procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 12, 2019) 		230
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2019) 		200
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Chen Wang 18518079870 wangchenpku@bjmu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03928899
Other Study ID Numbers  ICMJE PekingUFHIOL
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Wang Chen, Peking University First Hospital
Study Sponsor  ICMJE Peking University First Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Peking University First Hospital
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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