The Best Timing of Delivery in Women With GDM Study

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

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes; Induction of Labor Affected Fetus / Newborn
• Intervention / Treatment: Procedure: New procedure

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: Interventional
• Enrollment (Anticipated): 230
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chen Wang; Phone Number: 18518079870; Email: wangchenpku@bjmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Recruiting
      • Peking University First Hospital
      • Contact: Yumei Wei, MD; Phone Number: +8618601369529; Email: Weiyumei1982@126.com
      • Contact: Chen Wang; Phone Number: +8618518079870; Email: kisskissy22@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: New

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2019
• Primary Completion (Anticipated): May 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: April 18, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 26, 2019

Study Record Updates

• Last Update Posted (Actual): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 23, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: caesarean section; induction; Bishop score; fetal weight
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Diabetes, Gestational
• Other Study ID Numbers: PekingUFHIOL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No