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

BMC Pregnancy and Childbirth

Study Protocol

Chris McSweeney¹  H David McIntyre²  Anne Tremellen³  Shelley Wilkinson⁴  Leonie K Callaway⁵  Peter O’Rourke⁶  Katie Foxcroft⁷  Barbara Lingwood⁸  Marloes Dekker Nitert⁹  Helen L Barrett⁹  Jacinta M Tobin^1,10 

[1] CSIRO, St Lucia, Australia;Mater Clinical School, The University of Queensland, South Brisbane, Australia;Mater Medical Research Institute, Mothers’ & Babies Theme, South Brisbane, Australia;Mater Medical Research Institute, Mothers’ & Babies Theme, South Brisbane, Australia;Department of Nutrition & Dietetics, Mater Mothers’ Hospital, Brisbane, Australia;School of Medicine, The University of Queensland, Herston, Australia;The Royal Brisbane and Women’s Hospital, Herston, Australia;Statistics Unit, Queensland Institute of Medical Research, Herston, Australia;The Royal Brisbane and Women’s Hospital, Herston, Australia;The UQ Centre for Clinical Research, The University of Queensland, RBWH campus, Butterfield street, 4029, Herston, QLD, Australia;The UQ Centre for Clinical Research, The University of Queensland, RBWH campus, Butterfield street, 4029, Herston, QLD, Australia;School of Medicine, The University of Queensland, Herston, Australia;Western Clinical School, The University of Melbourne, Melbourne, Australia;

关键词: Gestational Diabetes Mellitus;    Oral Glucose Tolerance Test;    Gestational Diabetes;    Normal Weight Woman;    Obese Pregnant Woman;   

DOI  :  10.1186/1471-2393-13-50

 received in 2013-02-16, accepted in 2013-02-22,  发布年份 2013

来源: Springer

【 摘 要 】

BackgroundObesity 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/designSPRING 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.DiscussionSPRING 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.

【 授权许可】

CC BY   
© Nitert et al; licensee BioMed Central Ltd. 2013