Evidence map›Paper›PMID 23442391›Full record

Trial reportBMC pregnancy and childbirth2013

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

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 and 1 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC pregnancy and childbirth, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03834415 (Influence of Lactobacillus Reuteri DSM17938 on Early Gut Microbial Colonization in Infants Born by Caesarean Section), which is not on this map. Cited by 38 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 10 pooled it
9.0field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03834415 nacompletednot on this mapstarted 2019, after this paper: background citation

Influence of Lactobacillus Reuteri DSM17938 on Early Gut Microbial Colonization in Infants Born by Caesarean Section: A Double-blinded, Randomized, Placebo-controlled Study

TypeinterventionalSponsorInnovacion y Desarrollo de Estrategias en SaludRan2019 to 2019Enrolled69ConditionsC-sectionArmsLactobacillus reuteri DSM17038, Placebo for Probiotics
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 10 syntheses or guidelines pooled it, 84 citations in OpenAlex.

  1. Pooled it
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  5. Probiotics for preventing gestational diabetes.The Cochrane database of systematic reviews · 2021
    Pooled it
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  7. Serum levels of adipokines in gestational diabetes: a systematic review.Journal of endocrinological investigation · 2019
    Pooled it
  8. Pooled it
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  10. Probiotics for preventing gestational diabetes.The Cochrane database of systematic reviews · 2014
    Pooled it
  11. Trial
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  17. Article
  18. Article
  19. Gut Microbiome Changes in Gestational Diabetes.International journal of molecular sciences · 2022
    Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 1 country.

Marloes Dekker NitertThe UQ Centre for Clinical Research, The University of Queensland, RBWH campus, Butterfield street, Herston, QLD 4029, Australia. m.dekker@uq.edu.au
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
University of Queensland · AUCommonwealth Scientific and Industrial Research Organisation · AUMater Mothers' Hospital · AUQIMR Berghofer Medical Research Institute · AURoyal Brisbane and Women's Hospital · AUWestern Health · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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/m(2) will be recruited over 2 years and receive either probiotics or placebo capsules from 16 weeks gestation until delivery. The probiotics capsules contain > 1x10(9) 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.

Indexed as

AdultAustraliaDiabetes, GestationalDiet SurveysFeeding BehaviorFemaleGlucose Tolerance TestHumansObesityOverweightPregnancyPregnancy ComplicationsPrenatal Nutritional Physiological PhenomenaProbioticsProspective StudiesRegression Analysis

Identifiers

PMID23442391
PMCPMC3585705
OpenAlexW2165709112

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.