Nifedipine maintenance tocolysis and perinatal outcome: an individual participant data meta-analysis.

BACKGROUND: Preterm birth is the leading cause of neonatal mortality and morbidity in developed countries. Whether continued tocolysis after 48 hours of rescue tocolysis improves neonatal outcome is unproven. OBJECTIVES: To evaluate the effectiveness of maintenance tocolytic therapy with oral nifedipine on the reduction of adverse neonatal outcomes and the prolongation of pregnancy by performing an individual patient data meta-analysis (IPDMA). SEARCH STRATEGY: We searched PubMed, Embase, and Cochrane databases for randomised controlled trials of maintenance tocolysis therapy with nifedipine in preterm labour. SELECTION CRITERIA: We selected trials including pregnant women between 24 and 36(6/7)  weeks of gestation (gestational age, GA) with imminent preterm labour who had not delivered after 48 hours of initial tocolysis, and compared maintenance nifedipine tocolysis with placebo/no treatment. DATA COLLECTION AND ANALYSIS: The primary outcome was perinatal mortality. Secondary outcome measures were intraventricular haemorrhage (IVH), necrotising enterocolitis (NEC), infant respiratory distress syndrome (IRDS), prolongation of pregnancy, GA at delivery, birthweight, neonatal intensive care unit admission, and number of days on ventilation support. Pre-specified subgroup analyses were performed. MAIN RESULTS: Six randomised controlled trials were included in this IPDMA, encompassing data from 787 patients (n = 390 for nifedipine; n = 397 for placebo/no treatment). There was no difference between the groups for the incidence of perinatal death (risk ratio, RR 1.36; 95% confidence interval, 95% CI 0.35-5.33), intraventricular haemorrhage (IVH) ≥ grade II (RR 0.65; 95% CI 0.16-2.67), necrotising enterocolitis (NEC) (RR 1.15; 95% CI 0.50-2.65), infant respiratory distress syndrome (IRDS) (RR 0.98; 95% CI 0.51-1.85), and prolongation of pregnancy (hazard ratio, HR 0.74; 95% CI 0.55-1.01). CONCLUSION: Maintenance tocolysis is not associated with improved perinatal outcome and is therefore not recommended for routine practice. TWEETABLE ABSTRACT: Nifedipine maintenance tocolysis is not associated with improved perinatal outcome or pregnancy prolongation.

The effectiveness of glibenclamide in women with gestational diabetes.

BACKGROUND: Several studies have suggested that glibenclamide may be used safely and effectively in women with gestational diabetes mellitus (GDM). The aim of our study was to assess effectiveness and safety of glibenclamide for GDM in UK clinical practice. METHODS: Women with GDM requiring pharmacological therapy were offered a choice of insulin or glibenclamide. Maternal and foetal outcomes were assessed in women treated with insulin (45) or glibenclamide (44) and also compared with women treated with diet alone (55). RESULTS: Thirty-four (77%) achieved adequate glycaemic control with glibenclamide. Women choosing glibenclamide were more likely to be Asian and had higher fasting and 2-h glucose at diagnosis than those choosing insulin. There was no difference in maternal age or parity. Ten women treated with glibenclamide switched to insulin [inadequate control (7), unpredictable hypoglycaemia (1) and other reason (2)]. There was no difference in mode of birth, birth weight or birth weight centile between groups. One stillbirth occurred with glibenclamide. Glibenclamide treatment was associated with lower Apgar scores and increased neonatal jaundice. Neonatal hypoglycaemia occurred more frequently in babies of women treated with either glibenclamide or insulin. CONCLUSION: The use of glibenclamide in pregnancy is associated with adequate glycaemic control in 77% of women and achieved similar foetal outcomes to women treated with insulin.

An online tool for investigating clinical decision making.

BACKGROUND: Induction of labour is a common clinical intervention. There has been a recent rise in rates of induction of labour and wide variation between published hospital rates without obvious explanation. Clinician variation has been suggested as a reason. OBJECTIVE: The study described aimed to examine clinical decision making, whilst removing individual patient bias. To achieve this clinical behaviour was studied by the use of imaginary clinical scenarios presented to clinicians by computer. Unlike retrospective audit, the rates thus generated are unaffected by differences in casemix, pressure of time, work or other factors and allow direct comparison between clinicians and comparison with clinical guidelines. METHODS: Data about 15 imaginary pregnant women are presented to the clinician, each may have symptoms or signs of hypertensive disorders, intrauterine growth restriction (IUGR) and/or postdates. From the decision made in each scenario, and the information revealed about each scenario, a set of 'decision rules' is created for each clinician, describing in what circumstances they would induce labour. Data from the National Women's Hospital (Auckland, New Zealand) is then examined using these rules and the induction of labour rate thus generated presented to the clinician. RESULTS: Sixteen clinicians were interviewed. Their induction of labour rate ranged from 10-31%. CONCLUSIONS: Clinician variation in decision making is evident about the intervention when to induce labour. The system is available on the WWW at http://csrs2.aut.ac.nz/scenario