SUGAR-DIP trial: oral medication strategy versus insulin for diabetes in pregnancy, study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial.

INTRODUCTION: In women with gestational diabetes mellitus (GDM) requiring pharmacotherapy, insulin was the established first-line treatment. More recently, oral glucose lowering drugs (OGLDs) have gained popularity as a patient-friendly, less expensive and safe alternative. Monotherapy with metformin or glibenclamide (glyburide) is incorporated in several international guidelines. In women who do not reach sufficient glucose control with OGLD monotherapy, usually insulin is added, either with or without continuation of OGLDs. No reliable data from clinical trials, however, are available on the effectiveness of a treatment strategy using all three agents, metformin, glibenclamide and insulin, in a stepwise approach, compared with insulin-only therapy for improving pregnancy outcomes. In this trial, we aim to assess the clinical effectiveness, cost-effectiveness and patient experience of a stepwise combined OGLD treatment protocol, compared with conventional insulin-based therapy for GDM. METHODS: The SUGAR-DIP trial is an open-label, multicentre randomised controlled non-inferiority trial. Participants are women with GDM who do not reach target glycaemic control with modification of diet, between 16 and 34 weeks of gestation. Participants will be randomised to either treatment with OGLDs, starting with metformin and supplemented as needed with glibenclamide, or randomised to treatment with insulin. In women who do not reach target glycaemic control with combined metformin and glibenclamide, glibenclamide will be substituted with insulin, while continuing metformin. The primary outcome will be the incidence of large-for-gestational-age infants (birth weight >90th percentile). Secondary outcome measures are maternal diabetes-related endpoints, obstetric complications, neonatal complications and cost-effectiveness analysis. Outcomes will be analysed according to the intention-to-treat principle. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of the Utrecht University Medical Centre. Approval by the boards of management for all participating hospitals will be obtained. Trial results will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NTR6134; Pre-results.

Introduction of a dedicated team increases the success rate of external cephalic version: A prospective cohort study.

OBJECTIVE: To investigate the influence of a dedicated team on the success rate of external cephalic version and mode of delivery. STUDY DESIGN: This prospective cohort study included 673 women with a singleton fetus in breech presentation who underwent external cephalic version between January 2013 and December 2017 at Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands. In January 2014, a dedicated team consisting of six gynaecologists and six midwives was introduced at the study clinic. The success rate of external cephalic version and mode of delivery were analysed. In addition, predictors for success were examined by logistic regression analysis. Successful external cephalic version was defined as fetal cephalic presentation immediately following the procedure. RESULTS: Following the introduction of a dedicated team in 2014, the success rate of external cephalic version increased from 39.8% in 2013 to 69.5% in 2017 (p < 0.001), with the greatest increase in nulliparous women (from 23.5% to 58.5%, p = 0.002). Over the 5-year study period, the vaginal delivery rate after external cephalic version increased from 43% in 2013 to 71% in 2017 (p < 0.05). The rate of caesarean section after external cephalic version decreased from 55% to 27% (p < 0.05). Anterior placenta [odds ratio (OR) 0.7, 95% confidence interval (CI) 0.48‒0.97] and complete breech (OR 0.2, 95% CI 0.07‒0.90) were significantly associated with a lower success rate. CONCLUSIONS: This study showed that introduction of a dedicated team led to a significant increase in the success rate of external cephalic version, and a significant decrease in the rate of caesarean section for women presenting with breech in pregnancy.