Preventive Effect of Probiotics in GDM

Women's Hospital School Of Medicine Zhejiang University334 enrolled

Overview

Gut microbiota is instrumental in the microbial and metabolic network of pregnant women, and is potentially related with gestational diabetes. Perinatal probiotic intervention contributes to improved glucose regulation during pregnancy. Our randomized, double-centered, placebo-controlled study is planned to recruit 334 pregnant women who is in high risk for gestational diabetes. They will be assumed randomly probiotic powder per day or placebo from 12-16th gestational weeks until Oral Glucose Tolerance Test (OGTT) at 24-28th gestational weeks. Perinatal outcomes about neonatal weight will be registered.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

334

Conditions

Gestational Diabetes Mellitus (GDM)

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant women who meet the high-risk indicators for GDM and agree to participate in this study. 1. included between 12-16 gestational weeks 2. A woman was considered high risk when her pre-pregnancy BMI ≥ 24 kg/m\^2, having family history of diabetes (type 1 or 2), GDM or PCOS (polycystic ovary syndrome) history, history of delivering macrosomia or stillbirth, or glucose in urine (+) Exclusion Criteria: 1. Taking probiotics or prebiotics within the past month 2. Have a history of allergies to the drug components or similar drugs in this study 3. Having long-term smoking or drinking habits 4. Type 1 or type 2 diabetes patients with definite diagnosis before pregnancy 5. Diseases in other important organs such as heart, liver, and kidney 6. with clear digestive system diseases 7. Multiple pregnancy 8. with mental or cognitive impairments who are unable to complete this study

Outcomes

Primary Outcomes

the incidence of gestational diabetes

The number of cases and incidence of gestational diabetes according to OGTT

Time frame: 24-28th weeks gestation

Secondary Outcomes

The incidence of macrosomia

macrosomia refers to a newborn weighs more than 4 kg)

Time frame: Delivery

Weight gain during pregnancy (kg)

Weight gain during pregnancy (kg) = Maternal weight at delivery - weight pre-pregnancy

Time frame: Delivery

Central Contacts

Danqing Chen, Prof

CONTACT

86571-87061501 Chendq@zju.edu.cn

Xinning Chen