The Best Timing of Delivery in Women With GDM Study

Peking University

Status: Unknown

Conditions: Induction of Labor Affected Fetus / Newborn; Gestational Diabetes

Treatments: Procedure: New procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT03928899

PekingUFHIOL

Details and patient eligibility

About

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

Full 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.

Enrollment: 230 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

old guideline group

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Procedure: New procedure