Core outcomes in gestational diabetes for treatment trials: The Gestational Metabolic Group treatment set

Bashir, Mohammed; Syed, Asmir I.; Furuya‐Kanamori, Luis; Musa, Omran A. H.; Mohamed, Aisha M.; Skarulis, Monica C.; Thalib, Lukman; Konje, Justin C.; Abou‐Samra, Abdul‐Badi; Doi, Suhail A.R.

doi:10.1002/osp4.480

Cited by 4 publications

(4 citation statements)

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“…Of the six interventions identified, self-management programmes and medical nutrition/ diet therapy had the strongest evidence for the most promising outcomes -on postprandial blood glucose levels and health behaviour related outcomes. There is need for more research on the effectiveness of these interventions whilst focusing on core GDM outcomes [91][92][93][94] and the active components of these interventions. There may be need to compare the clinical and cost-effectiveness of these interventions with hospitalbased interventions.…”

Section: Discussionmentioning

confidence: 99%

Community-based non-pharmacological interventions for pregnant women with gestational diabetes mellitus: a systematic review

et al. 2022

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Background Non-pharmacological interventions are the first line of Gestational diabetes mellitus (GDM) management. Community-based interventions are cheaper, more accessible, with higher patient satisfaction. Objectives To systematically review community-based non-pharmacological interventions and evaluate their effectiveness for GDM. Search strategy Twelve bibliographic databases and reference list of related studies from inception until January 2022. Selection criteria All primary studies of community-based non-pharmacological interventions for GDM reported in English which investigated any behavioural or clinical outcome(s). Data collection and analysis Data were extracted using modified Cochrane’s data extraction template. Studies were evaluated using Cochrane Collaboration’s risk of bias tool. Narrative synthesis was used to summarise findings. This study is registered with PROSPERO (CRD42021257634). Main results Twenty-seven studies involving 6,242 pregnant women with GDM investigated self-management programmes, medical nutrition/diet therapy, exercise/physical activity, combined diet and exercise, calcium plus vitamin D supplementation, and continuous glucose monitoring. Self-management programmes were more effective than routine care in improving self-efficacy, two-hour postprandial blood glucose, and lifestyle behaviours but were as effective as routine care in improving infant birth weight. Self-management programmes were superior to or as effective as usual care in improving fasting blood glucose, blood glucose control, glycated haemoglobin, macrosomia, and preterm delivery. Medical nutrition/diet therapy was more effective than usual care in improving postprandial blood glucose levels. Postprandial blood glucose levels were better improved by regular supervised exercise plus daily brisk walks or a daily walking intervention than routine obstetric care or no treatment. The effects of exercise/physical activity programmes were mostly inconsistent for other outcomes. Diet and exercise were superior to diet alone in reducing maternal weight gain although there were similar outcomes for other pregnancy and foetal outcomes. Limited or conflicting evidence was found for other outcomes and interventions including calcium and vitamin D supplementation and continuous glucose monitoring intervention. Conclusions Community-based non-pharmacological interventions are more effective than placebo; and are more or as effective as usual care. Self-management programmes and medical nutrition/diet therapy had the most promising GDM outcomes. Funding There was no funding for this study. The study design, data collection, data analysis and interpretation, and writing of this manuscript were not influenced externally by any funder.

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Section: Discussionmentioning

confidence: 99%

Community-based non-pharmacological interventions for pregnant women with gestational diabetes mellitus: a systematic review

et al. 2022

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“…Thirteen of the studies were assessed as complying well with the COS-STAR criteria in most categories [12, 15, 19-22, 26-28, 30, 34, 37, 38], seven showed some deviations [13,17,18,25,29,32,33] and seven of the studies were assessed as having major shortcomings in reporting [14,16,23,24,31,35,36]; however, five of those were published prior to the publication of COS-STAR (Table 1 and Table S4). Most of the finalized studies lacked information about whether outcomes had been excluded at some stage or if outcomes had been merged.…”

Section: Use Of Methods and Representationmentioning

confidence: 99%

Core Outcome Sets (COS) related to pregnancy and childbirth: a systematic review

Österberg

Hellberg

Jonsson

et al. 2021

BMC Pregnancy Childbirth

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Background Systematic reviews often conclude low confidence in the results due to heterogeneity in the reported outcomes. A Core Outcome Set (COS) is an agreed standardised collection of outcomes for a specific area of health. The outcomes included in a COS are to be measured and summarized in clinical trials as well as systematic reviews to counteract this heterogeneity. Aim The aim is to identify, compile and assess final and ongoing studies that are prioritizing outcomes in the area of pregnancy and childbirth. Methods All studies which prioritized outcomes related to pregnancy and childbirth using consensus method, including Delphi surveys or consensus meetings were included. Searches were conducted in Ovid MEDLINE, EMBASE, PsycINFO, Academic Search Elite, CINAHL, SocINDEX and COMET databases up to June 2021. For all studies fulfilling the inclusion criteria, information regarding outcomes as well as population, method, and setting was extracted. In addition, reporting in the finalized studies was assessed using a modified version of the Core Outcome Set–STAndards for Reporting. Results In total, 27 finalized studies and 42 ongoing studies were assessed as relevant and were included. In the finalized studies, the number of outcomes included in the COS ranged from 6 to 51 with a median of 13 outcomes. The majority of the identified COS, both finalized as well as ongoing, were relating to physical complications during pregnancy. Conclusion There is a growing number of Core Outcome Set studies related to pregnancy and childbirth. Although several of the finalized studies follow the proposed reporting, there are still some items that are not always clearly reported. Additionally, several of the identified COS contained a large number (n > 20) outcomes, something that possibly could hinder implementation. Therefore, there is a need to consider the number of outcomes which may be included in a COS to render it optimal for future research.

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“…Pregnancy outcomes These will include caesarean section (emergency and elective), any assisted delivery methods (eg, vacuum and induced birth), preterm delivery (gestational age at delivery before 37 weeks), peripartum infection, pregnancy-induced hypertension and pre-eclampsia and eclampsia. 13 Maternal outcomes Maternal outcomes will include postpartum depression, postpartum type 2 diabetes at 6 weeks, glucose control during pregnancy (including blood glucose measurements), pregnancy loss, hospitalisation, intensive care unit and mortality within 6 weeks after delivery. 13 Fetal outcomes Fetal outcomes to be assessed in this study include the birth weight, large-for-gestational-age, small-forgestational-age, macrosomia, neonatal mortality (within 28 days), stillbirth, congenital abnormalities, shoulder dystocia, neonatal hypoglycaemia, neonatal hospitalisation and intensive care admission (neonatal intensive care unit) and respiratory distress syndrome.…”

Section: Outcomes Of Interestmentioning

confidence: 99%

“…13 Maternal outcomes Maternal outcomes will include postpartum depression, postpartum type 2 diabetes at 6 weeks, glucose control during pregnancy (including blood glucose measurements), pregnancy loss, hospitalisation, intensive care unit and mortality within 6 weeks after delivery. 13 Fetal outcomes Fetal outcomes to be assessed in this study include the birth weight, large-for-gestational-age, small-forgestational-age, macrosomia, neonatal mortality (within 28 days), stillbirth, congenital abnormalities, shoulder dystocia, neonatal hypoglycaemia, neonatal hospitalisation and intensive care admission (neonatal intensive care unit) and respiratory distress syndrome. Macrosomia would be defined as birth weight >90th percentile for gestational age or birth weight >4000 g. Perinatal mortality would be defined as any death around the time of delivery and include both fetal (of at least 20 weeks of gestation) and early infant (neonatal) deaths.…”

Section: Outcomes Of Interestmentioning

confidence: 99%

Adverse pregnancy outcomes in gestational diabetes mellitus: a systematic review and meta-analysis protocol

Chukwuemeka,

Chivese,

Gopinath

et al. 2024

BMJ Open

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IntroductionGestational diabetes mellitus (GDM) is associated with adverse pregnancy outcomes, including adverse outcomes for both the mother and the fetus. Different diagnostic criteria are used for GDM, and it is not clear how these affect the reported prevalence of adverse pregnancy outcomes. This protocol is for a systematic review to describe and compare the prevalence of adverse pregnancy outcomes in GDM using the different diagnostic criteria applied in various countries/regions of the world.Methods and analysisA systematic review and meta-analysis will be carried out. A comprehensive search of observational studies that report the outcomes of interest to this review from 2010 to 2021 will be conducted. We will search the major electronic databases such as PubMed, Scopus, CINHAL and Google Scholar, and screen references of included studies for additional studies. Meta-analyses will be performed, if there is low heterogeneity, and pooled estimates per outcome reported. We will use the bias-adjusted inverse variance heterogeneity model and random effects models, depending on the heterogeneity observed, to pool prevalence estimates and perform subgroup analyses by region, by age group, by diagnostic criteria and by GDM screening method if sufficient data are available. We will also compare the prevalence of adverse outcomes by diagnostic method and report prevalence ratios. We will report 95% confidence estimates for all estimates.Ethics and disseminationEthical approval is not required as the review uses published data. Findings will be published in peer-reviewed journals and presented at conferences.PROSPERO registration numberCRD42020155061.

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Core outcomes in gestational diabetes for treatment trials: The Gestational Metabolic Group treatment set

Cited by 4 publications

References 43 publications

Community-based non-pharmacological interventions for pregnant women with gestational diabetes mellitus: a systematic review

Community-based non-pharmacological interventions for pregnant women with gestational diabetes mellitus: a systematic review

Core Outcome Sets (COS) related to pregnancy and childbirth: a systematic review

Adverse pregnancy outcomes in gestational diabetes mellitus: a systematic review and meta-analysis protocol

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