BackgroundMetformin is widely used to treat gestational diabetes (GDM), but many women remain hyperglycaemic and require additional therapy. We aimed to determine recruitment rate and participant throughput in a randomised trial of glibenclamide compared with standard therapy insulin (added to maximum tolerated metformin) for treatment of GDM.MethodsWe conducted an open label feasibility study in 5 UK antenatal clinics among pregnant women 16 to 36 weeks’ gestation with metformin-treated GDM. Women failing to achieve adequate glycaemic control on metformin monotherapy were randomised to additional glibenclamide or insulin. The primary outcome was recruitment rate. We explored feasibility with uptake, retention, adherence, safety, glycaemic control, participant satisfaction and clinical outcomes.ResultsRecords of 197 women were screened and 23 women randomised to metformin and glibenclamide (n = 13) or metformin and insulin (n = 10). Mean (SD) recruitment rate was 0.39 (0.62) women/centre/month. 9/13 (69.2%, 95%CI 38.6–90.9%) women adhered to glibenclamide and all provided outcome data (100% retention). There were no episodes of severe hypoglycaemia, but metformin and insulin gave superior glycaemic control to metformin and glibenclamide, with fewer blood glucose readings <3.5 mmol/l (median [IQR] difference/woman/week of treatment 0.58 [0.03–1.87]).ConclusionsA large randomised controlled trial comparing glibenclamide or insulin in combination with metformin for women with GDM would be feasible but is unlikely to be worthwhile, given the poorer glycaemic control with glibenclamide and metformin in this pilot study. The combination of metformin and glibenclamide should be reserved for women with GDM with true needle phobia or inability to use insulin therapy.Trial registration www.clinicaltrials.gov registration number:NCT02080377 February 11th 2014.Electronic supplementary materialThe online version of this article (10.1186/s12884-017-1505-3) contains supplementary material, which is available to authorized users.
Recurrent miscarriage, the occurrence of three consecutive first-trimester losses of pregnancy, affects 1% of women. The purported causes of recurrent miscarriage include chromosomal abnormalities, thrombophilia, metabolic disorders, anatomical causes and immune factors. At present, the only recommended investigations are testing for lupus anticoagulant and anticardiolipin antibody levels (to diagnose antiphospholipid syndrome, an acquired thrombophilia) and the karyotyping of both parents for chromosomal abnormalities. Women with antiphospholipid syndrome should be offered treatment with aspirin and low molecular weight heparin. Couples with chromosomal abnormalities should be referred to a clinical geneticist with whom the options of prenatal diagnosis, pre-implantation genetic diagnosis, donor gametes and adoption in subsequent pregnancies should be discussed. Couples with unexplained recurrent miscarriage should be offered appropriate emotional support and reassurance that they have a good prognosis for future pregnancies. increases to approximately 50% for women with three or more losses without a liveborn infant. 6,7 The purported causes of recurrent miscarriage include chromosomal anomalies, thrombophilia, metabolic disorders, anatomical causes and immune factors.
Aims: To observe glucose profiles in post-partum women with type 1 diabetes with a particular focus on hypoglycaemia. Methods: Post-partum women with type 1 diabetes were studied for 4 weeks using home blood glucose monitoring (HBGM) and continuous glucose monitoring (CGM). Episodes of hypoglycaemia were documented using self-reported questionnaires. Results: Of 15 consenting participants, only six women completed the study, four of whom breastfed their baby. HBGM was performed a median of 7 times per day. No severe hypoglycaemia (requiring third party assistance) occurred, but a median of 17 (range 10-23) episodes of mild hypoglycaemia occurred. In all participants, CGM revealed several episodes of hypoglycaemia that were not detected by capillary blood glucose testing. Conclusions: Asymptomatic hypoglycaemia is common during breastfeeding. Recruitment and retention difficulties illustrate the challenge of studying glycaemia and intensive interventions in the post-partum period. Education programmes may help to reduce post-partum hypoglycaemia in women with type 1 diabetes. Br J Diabetes Vasc Dis 2015;15:119-122
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