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Effectiveness and acceptability of metformin in preventing the onset of type 2 diabetes after gestational diabetes in postnatal women: a protocol for a randomised, placebo-controlled, double-blind feasibility trial—Optimising health outcomes with Metformin to prevent diAbetes After pregnancy (OMAhA).

ABSTRACT: INTRODUCTION:Up to half of all women diagnosed with gestational diabetes mellitus develop type 2 diabetes within 5?years after delivery. Metformin is effective in preventing type 2 diabetes in high-risk non-pregnant individuals, but its effect when commenced in the postnatal period is not known. We plan to assess the feasibility of evaluating metformin versus placebo in minimising the risk of dysglycaemia including type 2 diabetes after delivery in postnatal women with a history of gestational diabetes through a randomised trial. METHODS AND ANALYSIS:Optimising health outcomes with Metformin to prevent diAbetes After pregnancy (OMAhA) is a multicentre placebo-controlled double-blind randomised feasibility trial, where we will randomly allocate 160 postnatal women with gestational diabetes treated with medication to either metformin (intervention) or placebo (control) tablets to be taken until 1?year after delivery. The primary outcomes are rates of recruitment, randomisation, adherence and attrition. The secondary outcomes are maternal dysglycaemia, cost and quality of life outcomes in both arms, and acceptability of the study and intervention, which will be evaluated through a nested qualitative study. Feasibility outcomes will be summarised using descriptive statistics, point estimates and 95% CIs. ETHICS AND DISSEMINATION:The OMAhA study received ethics approval from the London-Brent Research Ethics Committee (18/LO/0505). Trial findings will be published in a peer-reviewed journal, disseminated at conferences, through our Patient and Public Involvement advisory group (Katie's Team) and through social media platforms. TRIAL REGISTRATION NUMBER:ISRCTN20930880.

SUBMITTER: Amaefule CE

PROVIDER: S-EPMC7239519 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Effectiveness and acceptability of metformin in preventing the onset of type 2 diabetes after gestational diabetes in postnatal women: a protocol for a randomised, placebo-controlled, double-blind feasibility trial—Optimising health outcomes with Metformin to prevent diAbetes After pregnancy (OMAhA).

Amaefule Chiamaka Esther CE Bolou Angeliki A Drymoussi Zoe Z Gonzalez Carreras Francisco Jose FJ Pardo Llorente Maria Del Carmen MDC Lanz Doris D Dodds Julie J Sweeney Lorna L Pizzo Elena E D'Amico Maria M Thomas Amy A Heighway James J Daru Jahnavi J Sobhy Soha S Robson John J Sanghi Anita A Zamora Javier J Harden Angela A Hitman Graham G Khan Khalid K Pérez Teresa T Huda Mohammed Sb MS Thangaratinam Shakila S

BMJ open 20200517 5

<h4>Introduction</h4>Up to half of all women diagnosed with gestational diabetes mellitus develop type 2 diabetes within 5 years after delivery. Metformin is effective in preventing type 2 diabetes in high-risk non-pregnant individuals, but its effect when commenced in the postnatal period is not known. We plan to assess the feasibility of evaluating metformin versus placebo in minimising the risk of dysglycaemia including type 2 diabetes after delivery in postnatal women with a history of gesta ...[more]

PMID: 32423937

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Project description:BackgroundGestational diabetes mellitus (GDM) is associated with a range of adverse pregnancy outcomes for mother and infant. The prevention of GDM using lifestyle interventions has proven difficult. The gut microbiome (the composite of bacteria present in the intestines) influences host inflammatory pathways, glucose and lipid metabolism and, in other settings, alteration of the gut microbiome has been shown to impact on these host responses. Probiotics are one way of altering the gut microbiome but little is known about their use in influencing the metabolic environment of pregnancy.ObjectivesTo assess the effects of probiotic supplementation when compared with other methods for the prevention of GDM.Search methodsWe searched the Cochrane Pregnancy and childbirth Group's Trials Register (31 August 2013) and reference lists of the articles of retrieved studies.Selection criteriaRandomised and cluster-randomised trials comparing the use of probiotic supplementation with other methods for the prevention of the development of GDM. Cluster-randomised trials were eligible for inclusion but none were identified. Quasi-randomised and cross-over design studies are not eligible for inclusion in this review. Studies presented only as abstracts with no subsequent full report of study results would also have been excluded.Data collection and analysisTwo review authors independently assessed study eligibility, extracted data and assessed risk of bias of included study. Data were checked for accuracy.Main resultsEleven reports (relating to five possible trials) were found. We included one study (six trial reports) involving 256 women. Four other studies are ongoing.The included trial consisted of three treatment arms: probiotic with dietary intervention, placebo and dietary intervention, and dietary intervention alone; it was at a low risk of bias. The study reported primary outcomes of a reduction in the rate of gestational diabetes mellitus (risk ratio (RR) 0.38, 95% confidence interval (CI) 0.20 to 0.70), with no statistical difference in the rates of miscarriage/intrauterine fetal death (IUFD)/stillbirth/neonatal death (RR 2.00, 95% CI 0.35 to 11.35). Secondary outcomes reported were a reduction in infant birthweight (mean difference (MD) -127.71 g, 95% CI -251.37 to -4.06) in the probiotic group and no clear evidence of increased risk of preterm delivery (RR 3.27, 95% CI 0.44 to 24.43), or caesarean section rate (RR 1.23, 95% CI 0.65 to 2.32). The primary infant outcomes of rates of macrosomia and large-for-gestational age infants were not reported. The following secondary outcomes were not reported: maternal gestational weight gain, pre-eclampsia, and the long-term diagnosis of diabetes mellitus; infant body composition, shoulder dystocia, admission to neonatal intensive care, jaundice, hypoglycaemia and long-term rates of obesity and diabetes mellitus.Authors' conclusionsOne trial has shown a reduction in the rate of GDM when women are randomised to probiotics early in pregnancy but more uncertain evidence of any effect on miscarriage/IUFD/stillbirth/neonatal death. There are no data on macrosomia. At this time, there are insufficient studies to perform a quantitative meta-analysis. Further results are awaited from four ongoing studies.

Project description:ImportanceGestational diabetes is a common complication of pregnancy and the optimal management is uncertain.ObjectiveTo test whether early initiation of metformin reduces insulin initiation or improves fasting hyperglycemia at gestation weeks 32 or 38.Design, setting, and participantsDouble-blind, placebo-controlled trial conducted in 2 centers in Ireland (one tertiary hospital and one smaller regional hospital). Participants were enrolled from June 2017 through September 2022 and followed up until 12 weeks' postpartum. Participants comprised 510 individuals (535 pregnancies) diagnosed with gestational diabetes based on World Health Organization 2013 criteria.InterventionsRandomized 1:1 to either placebo or metformin (maximum dose, 2500 mg) in addition to usual care.Main outcomes and measuresThe primary outcome was a composite of insulin initiation or a fasting glucose level of 5.1 mmol/L or greater at gestation weeks 32 or 38.ResultsAmong 510 participants (mean age, 34.3 years), 535 pregnancies were randomized. The primary composite outcome was not significantly different between groups and occurred in 150 pregnancies (56.8%) in the metformin group and 167 pregnancies (63.7%) in the placebo group (between-group difference, -6.9% [95% CI, -15.1% to 1.4%]; relative risk, 0.89 [95% CI, 0.78-1.02]; P = .13). Of 6 prespecified secondary maternal outcomes, 3 favored the metformin group, including time to insulin initiation, self-reported capillary glycemic control, and gestational weight gain. Secondary neonatal outcomes differed by group, with smaller neonates (lower mean birth weights, a lower proportion weighing >4 kg, a lower proportion in the >90% percentile, and smaller crown-heel length) in the metformin group without differences in neonatal intensive care needs, respiratory distress requiring respiratory support, jaundice requiring phototherapy, major congenital anomalies, neonatal hypoglycemia, or proportion with 5-minute Apgar scores less than 7.Conclusion and relevanceEarly treatment with metformin was not superior to placebo for the composite primary outcome. Prespecified secondary outcome data support further investigation of metformin in larger clinical trials.Trial registrationClinicalTrials.gov Identifier: NCT02980276; EudraCT: 2016-001644-19.

Project description:BACKGROUND:Childbirth is a major risk factor for urinary incontinence (UI). As a result, pelvic floor muscle training (PFMT) is commonly recommended during and after pregnancy to prevent the onset of UI. PFMT is often classed as a physical activity (PA) behaviour, hence PA guidelines for postnatal women encourage PFMT alongside aerobic activities. However, postnatal lifestyle interventions tend to overlook PFMT which can be detrimental to women's health and future health risks, including urinary incontinence. This study aimed to explore perceptions and acceptability of a postnatal physical activity and PFMT intervention with postnatal women in Scotland. METHODS:We recruited women who had given birth within the last 5 years by displaying posters in health centres and community centres in Stirling and through Facebook. Data was gathered via online and face-to-face focus groups, that were audio recorded and transcribed verbatim. Analytic themes were initially organised under related concepts derived from the topic guide and thematic analysis conducted. Subsequent analysis was by the Framework technique. RESULTS:A total of seven online and face-to-face focus group discussions with 31 women identified there was a clear intention behaviour gap for engagement in PA, with both psychological and logistical barriers identified such as motivation and childcare. This was distinct from PFMT where there was a feeling of helplessness around not knowing how to perform a correct PFMT contraction subsequently resulting in women not adhering to PFMT guidance. Women felt there was no accessible PFMT advice available through the NHS. Some participants had received PFMT advice after childbirth and spoke of the Squeezee app being useful in adhering to a PFMT regimen but they did require additional teaching on how to do correct contractions. There was need for clarity and practical support for PFMT in the postnatal period with an approved intervention incorporating an accessible app being suggested by participants. CONCLUSIONS:Women would like to be trained on postnatal PFMT but face barriers to accessing adequate information and education on how to do a PFMT contraction. An intervention combining PFMT training and an app would be the most useful for their needs and circumstances.

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