Gestational DiabetesNCT03928899
The Best Timing of Delivery in Women With GDM Study
A study testing New procedure in people with Gestational Diabetes and Induction of Labor Affected Fetus / Newborn, run by Peking University First Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Induction of Labor Affected Fetus / Newborn
- What is being tested?
- New procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Yumei Wei, MD, +8618601369529, Weiyumei1982@126.com
Chen Wang, +8618518079870, kisskissy22@126.com
About this study
Official title: The Best Timing of Delivery in Women With GDM That is Controlled With Only Diet and Exercise
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
Read the 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.
- Being tested
- New procedure
- Keywords
- induction, caesarean section, fetal weight, Bishop score
- Medical subject headings
- Diabetes, Gestational, Fetal Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New procedureProcedure or surgery
Also called New
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.
| Study group | Role | What they receive |
|---|---|---|
| old guideline group | No intervention | 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. |
| new procedure group | Experimental | 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. Receives: Procedure: New procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
caesarean section rate
Measured: 41weeks
Secondary outcomes (27)
mode of delivery
spontaneous or operative vaginal delivery, caesarean section；the investigator will use questionnaire to collect these information from their medical record
Measured: 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
Measured: 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
Measured: 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
Measured: 41weeks
method of induction of labour
prostaglandin tablet regime; artificial rupture of amniotic membranes; oxytocin exclusive if used to accelerate normal labour
Measured: 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
Measured: 41weeks
gestational age
Measured: 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
Measured: 41weeks
birth weight
Measured: 41weeks
neonatal sex
Measured: 41weeks
neonatal plasma glucose level collected 1-2h after delivery
Measured: 41weeks
neonatal hypoglycemia
Measured: 41weeks
stillbirth
a baby delivered with no signs of life after24 completed weeks of pregnancy
Measured: 41weeks
shoulder dystocia
the investigator will use questionnaire to collect these information from their medical record
Measured: 41weeks
death before discharge from hospital
Measured: 41weeks
Apgar at 1 min, Apgar at 5 min, Apgar at 10 minutes
Measured: 41weeks
cord blood artery pH
Measured: 41weeks
neonatal respiratory distress
the investigator will use questionnaire to collect these information from their medical record
Measured: 41weeks
birth trauma
subdural haematoma, intracerebral or intraventricular haemorrhage, spinal-cord injury, basal skull fracture, peripheral-nerve injury, long bone fracture
Measured: 41weeks
NICU admission
Measured: 41weeks
seizures
the investigator will use questionnaire to collect these information from their medical record
Measured: 41weeks
hypotonia
the investigator will use questionnaire to collect these information from their medical record
Measured: 41weeks
intubation and ventilation for > 24 h
Measured: 41weeks
oxygen required
Measured: 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
Measured: 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)
Measured: 41weeks
rate of labor pain
Measured: 41weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start15 Jul 2019
- Primary completion31 May 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Chen, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928899
- Sponsor's protocol ID
- PekingUFHIOL
- Status last verified
- Sep 2021
- First submitted
- 18 Apr 2019
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Best Timing of Delivery in Women With GDM That is Controlled With Only Diet and Exercise
- ClinicalTrials.gov ID
- NCT03928899
- Acronym / sponsor ID
- PekingUFHIOL
- Keywords
- induction, caesarean section, fetal weight, Bishop score
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 26 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| old guideline group | No intervention | –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. |
| new procedure group | Experimental | Procedure: New procedureWomen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New procedureAlso: NewAn 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. | Procedure or surgery | new procedure group |
Primary outcome
caesarean section rate
Time frame: 41weeks
27 secondary outcomes
mode of delivery
Time frame: 41weeks
onset of labour
Time frame: 41weeks
operative vaginal delivery indication
Time frame: 41weeks
caesarean section indication
Time frame: 41weeks
method of induction of labour
Time frame: 41weeks
indication for induction
Time frame: 41weeks
gestational age
Time frame: 41weeks
intrapartum complications
Time frame: 41weeks
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
shoulder dystocia
Time frame: 41weeks
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
birth trauma
Time frame: 41weeks
NICU admission
Time frame: 41weeks
seizures
Time frame: 41weeks
hypotonia
Time frame: 41weeks
intubation and ventilation for > 24 h
Time frame: 41weeks
oxygen required
Time frame: 41weeks
the utilization of medical resources
Time frame: 41weeks
the mothers' expectations and experience of childbirth
Time frame: 41weeks
rate of labor pain
Time frame: 41weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New procedure in people with Gestational Diabetes and Induction of Labor Affected Fetus / Newborn, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Wang (18518079870, wangchenpku@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
caesarean section rate (time frame: 41weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.