The Best Timing of Delivery in Women With GDM Study

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03928899
• Other study ID #: PekingUFHIOL
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: Peking University First Hospital
• Contact: Chen Wang
• Phone: 18518079870
• Email: wangchenpku[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: December 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Induction of Labor Affected Fetus / Newborn

Intervention

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.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	caesarean section rate		41weeks
Secondary	mode of delivery	spontaneous or operative vaginal delivery, caesarean section;the investigator will use questionnaire to collect these information from their medical record	41weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	method of induction of labour	prostaglandin tablet regime; artificial rupture of amniotic membranes; oxytocin exclusive if used to accelerate normal labour	41weeks
Secondary	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
Secondary	gestational age		41weeks
Secondary	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
Secondary	birth weight		41weeks
Secondary	neonatal sex		41weeks
Secondary	neonatal plasma glucose level collected 1-2h after delivery		41weeks
Secondary	neonatal hypoglycemia		41weeks
Secondary	stillbirth	a baby delivered with no signs of life after24 completed weeks of pregnancy	41weeks
Secondary	shoulder dystocia	the investigator will use questionnaire to collect these information from their medical record	41weeks
Secondary	death before discharge from hospital		41weeks
Secondary	Apgar at 1 min, Apgar at 5 min, Apgar at 10 minutes		41weeks
Secondary	cord blood artery pH		41weeks
Secondary	neonatal respiratory distress	the investigator will use questionnaire to collect these information from their medical record	41weeks
Secondary	birth trauma	subdural haematoma, intracerebral or intraventricular haemorrhage, spinal-cord injury, basal skull fracture, peripheral-nerve injury, long bone fracture	41weeks
Secondary	NICU admission		41weeks
Secondary	seizures	the investigator will use questionnaire to collect these information from their medical record	41weeks
Secondary	hypotonia	the investigator will use questionnaire to collect these information from their medical record	41weeks
Secondary	intubation and ventilation for > 24 h		41weeks
Secondary	oxygen required		41weeks
Secondary	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
Secondary	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
Secondary	rate of labor pain		41weeks