scholarly journals Effectiveness and acceptability ofmyo-inositol nutritional supplement in the prevention of gestational diabetes (EMmY): a protocol for a randomised, placebo-controlled, double-blind pilot trial

BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e022831 ◽  
Author(s):  
Chiamaka Esther Amaefule ◽  
Zoe Drymoussi ◽  
Julie Dodds ◽  
Lorna Sweeney ◽  
Elena Pizzo ◽  
...  
Keyword(s):  
Gestational Diabetes ◽  
Plasma Glucose ◽  
Healthcare Professionals ◽  
Randomised Trial ◽  
Pilot Trial ◽  
Qualitative Evaluation ◽  
Nutritional Supplement ◽  
Cost Data ◽  
Advisory Group ◽  
Double Blind

IntroductionGestational diabetes increases maternal and offspring complications in pregnancy and cardiovascular complications in the long term. The nutritional supplementmyo-inositol may prevent gestational diabetes; however, further evaluation is required, especially in multiethnic high-risk mothers. Our pilot trial onmyo-inositol to prevent gestational diabetes will evaluate trial processes, assess acceptability to mothers and obtain preliminary estimates of effect and cost data prior to a large full-scale trial.Methods and analysisEMmY is a multicentre, placebo-controlled, double-blind, pilot, randomised trial, with qualitative evaluation. We will recruit pregnant women at 12–15+6weeks’ gestation, with gestational diabetes risk factors, from five maternity units in England between 2018 and 2019. We will randomise 200 women to take either 2 g ofmyo-inositol powder (intervention) or placebo, twice daily until delivery. We will assess rates of recruitment, randomisation, adherence to intervention and follow-up. Gestational diabetes will be diagnosed at 24–28 weeks as per the National Institute for Health and Care Excellence (NICE) criteria (fasting plasma glucose: ≥5.6 mmol/L and 2-hour plasma glucose: ≥7.8 mmol/L). We will assess the effects ofmyo-inositol on glycaemic indices at 28 weeks and on other maternal, fetal and neonatal outcomes at postnatal discharge. Qualitative evaluation will explore the acceptability of the trial and the intervention among women and healthcare professionals. Cost data and health-related quality of life measures will be captured. We will summarise feasibility outcomes using standard methods for proportions and other descriptive statistics, and where appropriate, report point estimates of effect sizes (eg, mean differences and relative risks) and associated 95% CIs.Ethics and disseminationEthical approval was obtained through the London Queen Square Research Ethics Committee (17/LO/1741). Study findings will be submitted for publication in peer-reviewed journals. Newsletters will be made available to participants, healthcare professionals and members of Katie’s Team (a patient and public advisory group) to disseminate.Trial registration numberISRCTN48872100.Protocol version and dateVersion 4.0, 15 January 2018.

scholarly journals 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 trialOptimising health outcomes with Metformin to prevent diAbetes After pregnancy (OMAhA)

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e036198
Author(s):  
Chiamaka Esther Amaefule ◽  
Angeliki Bolou ◽  
Zoe Drymoussi ◽  
Francisco Jose Gonzalez Carreras ◽  
Maria del Carmen Pardo Llorente ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Gestational Diabetes ◽  
Health Outcomes ◽  
Randomised Trial ◽  
Feasibility Trial ◽  
Placebo Control ◽  
Advisory Group ◽  
Double Blind ◽  
Postnatal Women

IntroductionUp 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 analysisOptimising 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 disseminationThe 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 numberISRCTN20930880

scholarly journals Effect of early cryoprecipitate transfusion versus standard care in women who develop severe postpartum haemorrhage (ACROBAT) in the UK: a protocol for a pilot cluster randomised trial

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e036416
Author(s):  
Laura Green ◽  
Jahnavi Daru ◽  
Julie Dodds ◽  
Francisco Jose Gonzalez Carreras ◽  
Doris Lanz ◽  
...  
Keyword(s):  
Pilot Study ◽  
Postpartum Haemorrhage ◽  
Randomised Trial ◽  
Intervention Group ◽  
Qualitative Evaluation ◽  
Primary Objective ◽  
Cluster Randomised Trial ◽  
Control Group ◽  
Advisory Group ◽  
Cluster Randomised

IntroductionThe incidence of severe postpartum haemorrhage (PPH) that requires blood transfusion is on the increase. Fibrinogen levels have been shown to drop early and significantly during PPH, which is associated with worse outcomes. Early fibrinogen replacement could potentially improve outcomes. No studies have investigated the clinical impact of early cryoprecipitate transfusion in PPH. Prior to performing a full-scale trial, a pilot study is needed to determine feasibility of the intervention and recruitment.MethodsACROBAT is a cluster-randomised pilot study with a qualitative evaluation. Four large London maternity units are randomised to either the intervention or control group. The intervention group will adapt their major obstetric haemorrhage procedures to administer cryoprecipitate early for primary PPH. The control group will retain their standard of care.We include women at >24 weeks gestation who are actively bleeding within 24 hours of delivery and for whom transfusion of red blood cells (RBCs) has been started. We exclude women who decline blood transfusions in advance or have inherited Factor XIII or fibrinogen deficiency. Due to the emergency nature of the intervention, informed consent for administering the intervention is waived.The primary objective is to assess the feasibility of administering cryoprecipitate within 90 min of RBC request, as compared with standard treatment where cryoprecipitate is given later or not at all. Secondary objectives include the feasibility of recruitment and data collection, reasons for and barriers to consent, preliminary maternal clinical outcomes, identification of the optimal infrastructure pathways for study delivery, and acceptability of the intervention and outcomes.Ethics and disseminationThe trial has approvals from the London—Brighton & Sussex Research Ethics Committee (ref. 18/LO/2062), the Confidentiality Advisory Group (ref. 18/CAG/0199) and Health Research Authority (IRAS number 237959). Data analysis and publication of manuscripts will start in Q3 2020.Trial registration numberISRCTN12146519.

scholarly journals P201 Therapists' experiences of remotely delivered cognitive-behavioural and graded-exercise interventions to lessen the impact of fatigue in inflammatory rheumatic diseases: a qualitative evaluation

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Sarah E Bennett ◽  
Emma Dures ◽  
Celia Almeida ◽  
Eva-Maria Bachmair ◽  
Karina Lovell ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Rheumatic Diseases ◽  
Health Professionals ◽  
Service Provision ◽  
Healthcare Professionals ◽  
Randomised Trial ◽  
Qualitative Evaluation ◽  
Inflammatory Rheumatic Diseases ◽  
Cognitive Behavioural ◽  
The Impact

Abstract Background/Aims  There is evidence for non-pharmacological interventions to support patients to self-manage fatigue, however implementation in clinical practice is a challenge. LIFT (Lessening the Impact of Fatigue in inflammatory rheumatic diseases: a randomised Trial) is a multi-centre three-arm randomised trial using a remotely delivered cognitive-behavioural approach (CBA) or personalized exercise programme (PEP) interventions, in addition to usual care, compared to normal care alone. Interventions were delivered to patients by rheumatology health professionals using a manual, after training. The aim of this nested qualitative evaluation was to understand their perspectives of delivering the interventions. Methods  A subgroup of rheumatology healthcare professionals who had delivered the CBA and PEP interventions took part in semi-structured telephone interviews to explore their experiences of training and delivery, the challenges and benefits of learning new skills, and the barriers and facilitators to supporting patients remotely (mainly by telephone) using the LIFT manual. Results  A total of 17 rheumatology healthcare professionals (13 women, 4 men) from the CBA (n = 9) and PEP (n = 8) arms contributed. SB conducted an inductive thematic analysis of the data set. ED, CA, AW and KL reviewed a sub-set of transcripts. Five main themes were identified: The benefits of informative, structured training: Rheumatology healthcare professionals reflected how training, including role-play, helped them to practice their skills, even though this could feel uncomfortable. Those allocated shorter four-hour training sessions would have liked more time to practice. Many felt anxious before meeting patients for the first time but liked the manual to refer to. Getting into the swing of it: Practice gave rheumatology healthcare professionals the confidence to tailor content to individual patients’ requirements. Clinical supervision in the PEP and CBA arm supported rheumatology healthcare professionals to query their own practice, gain valuable feedback, and request assistance where needed. Benefits of telephone delivery: The initial face-to-face session enabled rheumatology healthcare professionals to build rapport with patients. Thereafter, patients seemed engaged and valued the opportunity to address their fatigue and challenge their own beliefs via the telephone. Some patients not ready to change: Rheumatology healthcare professionals struggled to work collaboratively with a minority of patients who were not willing to make changes, lacked motivation to complete tasks or stopped engaging with the intervention. LIFT developing clinical skills: Rheumatology healthcare professionals were confident that they were doing the ‘right thing’ for patients with fatigue and gained professional satisfaction seeing patients’ fatigue improve. Many felt that the skills they acquired and their experiences of remote delivery were helping them to respond to the current COVID-19 related changes in service provision. Conclusion  Findings support the value of skills training for rheumatology health professionals to deliver fatigue management interventions remotely. These insights can inform service provision and clinical practice. Disclosure  S.E. Bennett: None. E. Dures: None. C. Almeida: None. E. Bachmair: None. K. Lovell: None. L. Paul: None. A. Wearden: None. G.J. Macfarlane: None. N. Basu: None.

scholarly journals Lower versus higher diagnostic criteria for the detection of gestational diabetes for reducing maternal and perinatal morbidity: study protocol for the GEMS randomised trial

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Caroline A. Crowther ◽  
◽  
Lesley M. E. McCowan ◽  
Janet A. Rowan ◽  
Richard Edlin ◽  
...  
Keyword(s):  
Birth Weight ◽  
Gestational Diabetes ◽  
Diagnostic Criteria ◽  
Gestational Age ◽  
Plasma Glucose ◽  
Fasting Plasma Glucose ◽  
Randomised Trial ◽  
Perinatal Outcomes ◽  
Large For Gestational Age ◽  
Fasting Plasma

Abstract Background Gestational diabetes mellitus (GDM) has lifelong implications for the woman and her infant. Treatment reduces adverse maternal and perinatal outcomes although uncertainty remains about the optimal diagnostic criteria. The GEMS Trial aims to assess whether detection and treatment of women with GDM using the lower International Association of Diabetes in Pregnancy Study Groups diagnostic criteria compared with the higher criteria recommended in New Zealand reduces infant morbidity without increasing maternal morbidity. Methods GEMS is a multicentre, randomised trial. Women with a singleton pregnancy at 24 to 34 weeks’ gestation are eligible who give written informed consent. Women are randomly allocated to the Lower Criteria Group or the Higher Criteria Group. Women with a normal OGTT by their allocated criteria receive routine care (Higher criteria: fasting plasma glucose < 5.5 mmol/L, AND 2 hour < 9.0 mmol/L; Lower criteria: fasting plasma glucose < 5.1 mmol/L, AND 1 hour < 10.0 mmol/L, AND 2 hour < 8.5 mmol/l). Women with GDM on OGTT by their allocated criteria receive standard care for GDM (Higher criteria: fasting plasma glucose ≥ 5.5 mmol/L, OR 2 hour ≥ 9.0 mmol/L; Lower criteria: fasting plasma glucose ≥ 5.1 mmol/L, OR 1 hour ≥ 10.0 mmol/L, OR 2 hour ≥ 8.5 mmol/L). The primary outcome is large for gestational age (birth weight > 90th centile). Secondary outcomes for the infant include a composite of serious outcomes, gestational age, anthropometry, Apgar score < 4 at 5 minutes, lung disease, use of respiratory support, hypoglycaemia, hyperbilirubinaemia, infection, and encephalopathy; and for the woman, a composite of serious outcomes, preeclampsia, induction of labour, mode of birth, weight gain, postpartum haemorrhage and infectious morbidity. A study with 4,158 women will detect an absolute difference of 2.9% in the proportion of large for gestational age infants from 10.0% using the lower criteria to 12.9% with the higher criteria. Discussion The GEMS Trial will provide high-level evidence relevant for clinical practice. If use of the lower diagnostic criteria results in significantly fewer large for gestational age infants and/or improves maternal and perinatal outcomes these criteria should be recommended for diagnosis of gestational diabetes. Trial registration Australian New Zealand Clinical Trials Registry registration number ACTRN12615000290594. Date registered: 27th March 2015.

Phytosterol nutritional supplement improves pregnancy and neonatal complications of gestational diabetes mellitus in a double-blind and placebo-controlled clinical study

2017 ◽  
Vol 8 (1) ◽  
pp. 424-428 ◽  
Author(s):  
Fang Gao ◽  
Guangya Wang ◽  
Linxia Wang ◽  
Ningning Guo
Keyword(s):  
Diabetes Mellitus ◽  
Clinical Study ◽  
Gestational Diabetes ◽  
Gestational Diabetes Mellitus ◽  
Pregnant Women ◽  
Health Problem ◽  
Nutritional Supplement ◽  
Double Blind ◽  
Neonatal Complications ◽  
Controlled Clinical Study

Gestational diabetes mellitus (GDM) is an increasingly serious health problem among pregnant women.

Evaluating the implementation potential of a transcultural tool for Tamil migrants with gestational diabetes mellitus living in Switzerland

2017 ◽  
Vol 2 (2) ◽  
Keyword(s):  
Diabetes Mellitus ◽  
Logistic Regression ◽  
Gestational Diabetes ◽  
Gestational Diabetes Mellitus ◽  
Online Survey ◽  
Healthcare Professionals ◽  
Binary Logistic Regression ◽  
Private Practices ◽  
Populations At Risk ◽  
Management Procedures

Background: Gestational diabetes mellitus is a condition that affects many pregnancies and ethnicity appears to be a risk factor. Data indicate that approximately 18% of Tamil women are diagnosed with gestational diabetes mellitus. Today, approximately 50,000 of Tamils live in Switzerland. To date, there is no official tool available in Switzerland that considers the eating and physical activity habits of this migrant Tamil population living in Switzerland, while offering a quick overview of gestational diabetes mellitus and standard dietetics management procedures. The NutriGeD project led by Bern University of Applied Sciences in Switzerland aimed at closing this gap. The aim of this present study was to evaluate the implementation potential of the tools developed in the project NutriGeD for dietetic counseling before their wide scale launch in Swiss hospitals, clinics and private practices. Method: An online survey was developed and distributed to 50 recruited healthcare professionals working in the German speaking region of Switzerland from October – December 2016 (31% response rate). The transcultural tools were sent to participants together with the link to the online survey. The evaluation outcome was analysed using binary logistic regression and cross tabulation analysis with IBM SPSS version 24.0, 2016. Results: 94% (N=47) respondents believed that the transcultural tools had good potential for implementation in hospitals and private practices in Switzerland. A binary logistic regression analysis revealed that the age of participants had a good correlation (42.1%) on recommending the implementation potential of the transcultural tool. The participants with age group 34- 54 years old where the highest group to recommend the implementation potential of the transcultural tool and this was found to be statistically significant (p=0.05). 74% (34 out of 50) of the respondents clearly acknowledged the need for transcultural competence knowledge in healthcare practices. 80% (N =40) of the respondents agreed that the information presented in the counseling display folder was important and helpful while 60% (N= 30) agreed to the contents being clinically applicable. 90% (N=45) participants recommended the availability of the evaluated transcultural tools in healthcare settings in Switzerland. Conclusion: The availability in healthcare practice of the evaluated transcultural tools was greatly encouraged by the Swiss healthcare practitioners participating in the survey. While they confirmed the need for these transcultural tools, feed-backs for minor adjustments were given to finalize the tools before their official launch in practice. The developed materials will be made available for clinical visits, in both hospitals and private practices in Switzerland. The Migmapp© transcultural tool can serve as a good approach in assisting healthcare professionals in all fields, especially professionals who practice in areas associated with diet - related diseases or disorders associated with populations at risk.

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