Lindsay 2015.
Study characteristics | ||
Methods | Parallel randomised controlled trial | |
Participants | Pregnant women with GDM (n = 149). Setting National Maternity Hospital, Dublin, Ireland Dates of Study March 2012 to May 2014. Final birth July 2014 Inclusion criteria Pregnant women attending the National Maternity Hospital who were newly diagnosed with either IGT (1 raised value) or GDM (2 raised values) following a 3‐hour 100‐g OGTT in the current pregnancy, age > 18 years, < 34 weeks’ gestation, singleton pregnancy and adequate English Exclusion criteria Pregestational diabetes, were aged < 18 years, were 34 weeks’ gestation, had a multiple pregnancy or fetal anomaly, were commenced on insulin or metformin therapy immediately after diagnosis, or had a poor understanding of the English language |
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Interventions | Probiotic: capsule contained 100 mg of Lactobacillus salivarius UCC118 at a target dose of 109 CFU (n = 74). Placebo: identical in appearance to probiotics (n = 75). |
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Outcomes | Maternal outcomes: FPG, C‐peptide, triglycerides; requirement for pharmacological
therapy, Total, LDL, and HDL cholesterol, insulin, and triglycerides, HOMAR‐IR, gestational weight gain, hypertension, delivery complications Neonatal/infant outcomes: birthweight, glucose, c‐peptide, lipids, 5‐minute Apgar score, and admission to NICU |
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Notes |
Funding: National Maternity Hospital Medical Fund with support from the Ivo Drury Award and the European Union’s Seventh Framework Program (FP7/2007‐2013), project Early Nutrition under grant agreement number 289346. Conflicts of interest: F.S. is a shareholder in Alimentary Health Ltd and has received grants from GlaxoSmithKline and the Procter and Gamble Company in the past. The remaining authors report no conflict of interest. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated simple randomisation process in a ratio of 1:1. |
Allocation concealment (selection bias) | Low risk | Allocation to either 1 of the capsules was conducted by an independent researcher. The allocation sequence was sequentially numbered in sealed, opaque envelopes and was concealed from the research dietitian enrolling and assessing the participants. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Probiotics and placebo identical capsules were supplied and researchers and participants were unaware of the allocation. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | All clinical and laboratory staff who were involved with care of study participants or analysis of samples remained blinded to the allocation sequence |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 149 women randomised. In the probiotic arm, 9 women were lost to follow‐up, 4 discontinued intervention when they changed their minds. In the placebo arm, 9 women were lost to follow‐up and 4 changes their minds. 79 were analysed |
Selective reporting (reporting bias) | Unclear risk | No retrospective trial registration. Insufficient information to judge if pre‐specified outcomes are reported in full. |
Other bias | Low risk | There was a slightly lower rate of Caucasian ethnicity and obesity and a higher rate of primiparity in the probiotic compared to placebo group but these differences were not significant. Otherwise the groups were balanced at the baseline |