The Best Timing of Delivery in Women With GDM Study

Peking University First Hospital230 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

230

Conditions

Gestational Diabetes Induction of Labor Affected Fetus / Newborn

Interventions

New procedurePROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

caesarean section rate

Time frame: 41weeks

Secondary Outcomes

mode of delivery

spontaneous or operative vaginal delivery, caesarean section；the investigator will use questionnaire to collect these information from their medical record

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 41weeks

method of induction of labour

prostaglandin tablet regime; artificial rupture of amniotic membranes; oxytocin exclusive if used to accelerate normal labour

Time frame: 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

Central Contacts

Chen Wang

CONTACT

18518079870 wangchenpku@bjmu.edu.cn

Data from ClinicalTrials.gov

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