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BMC Pregnancy and Childbirth
Published in: BMC Pregnancy and Childbirth 1/2013

Open Access 01-12-2013 | Study protocol

SPRING: an RCT study of probiotics in the prevention of gestational diabetes mellitus in overweight and obese women

Authors: Marloes Dekker Nitert, Helen L Barrett, Katie Foxcroft, Anne Tremellen, Shelley Wilkinson, Barbara Lingwood, Jacinta M Tobin, Chris McSweeney, Peter O’Rourke, H David McIntyre, Leonie K Callaway

Published in: BMC Pregnancy and Childbirth | Issue 1/2013

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Abstract

Background

Obesity is increasing in the child-bearing population as are the rates of gestational diabetes. Gestational diabetes is associated with higher rates of Cesarean Section for the mother and increased risks of macrosomia, higher body fat mass, respiratory distress and hypoglycemia for the infant. Prevention of gestational diabetes through life style intervention has proven to be difficult. A Finnish study showed that ingestion of specific probiotics altered the composition of the gut microbiome and thereby metabolism from early gestation and decreased rates of gestational diabetes in normal weight women. In SPRING (the Study of Probiotics IN the prevention of Gestational diabetes), the effectiveness of probiotics ingestion for the prevention of gestational diabetes will be assessed in overweight and obese women.

Methods/design

SPRING is a multi-center, prospective, double-blind randomized controlled trial run at two tertiary maternity hospitals in Brisbane, Australia. Five hundred and forty (540) women with a BMI > 25.0 kg/m2 will be recruited over 2 years and receive either probiotics or placebo capsules from 16 weeks gestation until delivery. The probiotics capsules contain > 1x109 cfu each of Lactobacillus rhamnosus GG and Bifidobacterium lactis BB-12 per capsule. The primary outcome is diagnosis of gestational diabetes at 28 weeks gestation. Secondary outcomes include rates of other pregnancy complications, gestational weight gain, mode of delivery, change in gut microbiome, preterm birth, macrosomia, and infant body composition. The trial has 80% power at a 5% 2-sided significance level to detect a >50% change in the rates of gestational diabetes in this high-risk group of pregnant women.

Discussion

SPRING will show if probiotics can be used as an easily implementable method of preventing gestational diabetes in the high-risk group of overweight and obese pregnant women.
Appendix
Available only for authorised users
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Metadata
Title
SPRING: an RCT study of probiotics in the prevention of gestational diabetes mellitus in overweight and obese women
Authors
Marloes Dekker Nitert
Helen L Barrett
Katie Foxcroft
Anne Tremellen
Shelley Wilkinson
Barbara Lingwood
Jacinta M Tobin
Chris McSweeney
Peter O’Rourke
H David McIntyre
Leonie K Callaway
Publication date
01-12-2013
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2013
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/1471-2393-13-50

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