Probiotics in the prevention of Gestational Diabetes Mellitus in women at increased risk: a prospective randomised controlled trial.

Not Applicable

• Conditions: Gestational Diabetes Mellitus; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12620000359932
• Lead Sponsor: Dr Anushika Samarage

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-13
• Last Update Posted: 23 March 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 340

Inclusion Criteria

All pregnant women >10 weeks gestation, in a singleton pregnancy at increased risk of gestational diabetes as per the Australasian Diabetes in Pregnancy Society (ADIPS) criteria will be eligible for the study:
• Previous GDM
• Maternal age 18 years to 40 years
• Family history of diabetes (1st degree relative with diabetes or a sister with GDM)
• BMI over 35kg/m2
• Previous macrosomia (baby birth weight over 4500g or over 90th centile)
• Polycystic ovarian syndrome

Exclusion Criteria

• Not being able to read and understand English – unable to provide informed consent.
• Age <18 years
• Pregnancy >16 weeks gestation at recruitment
• Known pre-existing diabetes, impaired fasting glucose or impaired glucose tolerance
• GDM prior to recruitment as diagnosed by early pregnancy glucose testing – Early
pregnancy glucose testing routinely done for women at increased risk of GDM
• Medications likely to influence glucose metabolism – metformin, glucocorticoids,
immunosuppressants
• Medical conditions with altered glucose metabolism – Cushing/s syndrome, hepatic
cirrhosis
• Known major fetal anomaly on ultrasound
• Known current ingestion of probiotics via capsules or sachets
• Antibiotic use during the study period

Study & Design

• Study Type: Interventional
• Study Design: Not specified