Glibenclamide and metfoRmin versus stAndard care in gEstational diabeteS (GRACES): a feasibility open label randomised trial.

BACKGROUND: Metformin 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. METHODS: We 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. RESULTS: Records 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]). CONCLUSIONS: A 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.

Screening and management of gestational diabetes mellitus in Scottish obstetric units: a national survey.

BACKGROUND AND AIMS: The last study of screening practices for gestational diabetes (GDM) in the UK concluded that a lack of consensus about screening was due to a lack of clinical guidelines. We aimed to determine current practices in Scotland since new guidelines recommended that diagnosis should be made at a lower level of hyperglycaemia. METHOD AND RESULTS: An online questionnaire designed to investigate the screening and management of GDM was distributed to all maternity units in Scotland managing women with GDM (n = 15) for completion by relevant clinical team members. The response rate was 100%. Considerable variation in clinical practice existed between units. Thirteen units (86.7%) had adopted the lower glucose tolerance values for diagnosis of GDM (fasting ≥5.1 mmol/L; 2-h ≥8.5 mmol/L) recommended by the Scottish Intercollegiate Guidelines Network in 2010. Available data from units using this guideline (n = 3) revealed a significant increase in the percentage of women diagnosed with GDM between 2010 and 2012 (2010: 1.28%, 2012: 2.54%; p < 0.0001). CONCLUSION: Despite provision of clinical guidelines, there are still inconsistencies in screening and management of GDM in Scotland. If a similar increase in the prevalence of GDM is experienced across Scotland, there will be major implications for health care provision and resource allocation.

Major placenta praevia should not preclude out-patient management.

OBJECTIVE: To review current management of women with major and minor placenta praevia in view of the recommendations made in the RCOG guideline 2001. To assess whether out-patient care was detrimental to pregnancy outcome. STUDY DESIGN: Retrospective observational study at the Simpson Memorial Maternity Pavilion, Edinburgh (a tertiary referral centre). One hundred and sixty-one women with major and minor placenta praevia between 1994 and 2000 were separated into those who experienced bleeding (antepartum haemorrhage (APH)) and those who had no bleeding during pregnancy (non-APH). Statistical analysis was carried out using SPSS. RESULTS: There were 129 women (80%) in the APH group. Forty-three were out-patients at the time of delivery and 63% had a major degree of praevia. Thirty-two women were in the non-APH group. Sixty-eight were managed as out-patients and 50% had a major degree of praevia. Women with a major degree of praevia were not significantly more likely to experience bleeding. Women with APH were significantly more likely to be delivered early, by emergency caesarean section (C/S), of lower birthweight babies who required neonatal admission than the non-APH group. CONCLUSION: There is a place for out-patient management of women with placenta praevia. Caution is required with increasing number of bleeds but not degree of praevia.