The Best Timing of Delivery in Women With GDM Study

NCT03928899 | Unknown

• 1 other identifier: PekingUFHIOL
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Gestational Diabetes; Induction of Labor Affected Fetus / Newborn

Keywords

induction; caesarean section; fetal weight; Bishop score

Outcome Measures

Primary Outcomes (1)

• caesarean section rate

  41weeks

Secondary Outcomes (27)

• mode of delivery

  41weeks

• onset of labour

  41weeks

• operative vaginal delivery indication

  41weeks

• caesarean section indication

  41weeks

• method of induction of labour

  41weeks

Study Arms (2)

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.

Procedure: New procedure

Interventions

New procedure 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.

Also known as: New

new procedure group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational; Fetal Weight

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chen Wang

CONTACT

18518079870; wangchenpku@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 26, 2019
• Study Start: July 15, 2019
• Primary Completion: May 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 27, 2021

Record last verified: 2021-09

Locations

CN (1)