Effect of the Dutch Hip Fracture Audit implementation on mortality, length of hospital stay and time until surgery in elderly hip fracture patients; a multi-center cohort study

Background: In 2040 the estimated number of people with a hip fracture in the Netherlands will be about 24,000. The medical care for this group of patients is complicated and challenging. Multidisciplinary approaches aim to improve clinical outcome. Quality indicators that gain insight in the treatment and outcome of hip fracture patients may help to optimize and monit

Low dose aspirin in the prevention of recurrent spontaneous preterm labour - the APRIL study: A multicenter randomized placebo controlled trial

Background: Preterm birth (birth before 37 weeks of gestation) is a major problem in obstetrics and affects an estimated 15 million pregnancies worldwide annually. A history of previous preterm birth is the strongest risk factor for preterm birth, and recurrent spontaneous preterm birth affects more than 2.5 million pregnancies each year. A recent meta-analysis showed possible benefits of the use of low dose aspirin in the prevention of recurrent spontaneous preterm birth. We will assess the (cost-)effectiveness of low dose aspirin in comparison with placebo in the prevention of recurrent spontaneous preterm birth in a randomized clinical trial. Methods/design: Women with a singleton pregnancy and a history of spontaneous preterm birth in a singleton pregnancy (22-37 weeks of gestation) will be asked to participate in a multicenter, randomized, double blinded, placebo controlled trial. Women will be randomized to low dose aspirin (80 mg once daily) or placebo, initiated from 8 to 16 weeks up to maximal 36 weeks of gestation. The primary outcome measure will be preterm birth, defined as birth at a gestational age (GA) < 37 weeks. Secondary outcomes will be a composite of adverse neonatal outcome and maternal outcomes, including subgroups of prematurity, as well as intrauterine growth restriction (IUGR) and costs from a healthcare perspective. Preterm birth will be analyzed as a group, as well as separately for spontaneous or indicated onset. Analysis will be performed by intention to treat. In total, 406 pregnant women have to be randomized to show a reduction of 35% in preterm birth from 36 to 23%. If aspirin is effective in preventing preterm birth, we expect that there will be cost savings, because of the low costs of aspirin. To evaluate this, a cost-effectiveness analysis will be performed comparing preventive treatment with aspirin with placebo. Discussion: This trial will provide evidence as to whether or not low dose aspirin is (cost-) effective in reducing recurrence of spontaneous preterm birth. Trial registration: Clinical trial registration number of the Dutch Trial Register: NTR 5675. EudraCT-registration number: 2015-003220-31

Fever following misoprostol in terminations of pregnancy.

Background: A termination of pregnancy (TOP) is common practice. This can be performed in a medical and a surgical way. For medical abortion in the second trimester the currently used method is the combination of mifepristone and misoprostol. Fever is a common side effect of misoprostol. In the indication TOP, fever as a primary outcome has not been investigated. The aim of this study was to determine the incidence of fever after administration of misoprostol for the indication termination of pregnancy (TOP) and to investigate which cases of fever are caused by an intra uterine infection (IUI) and which ones were side effects of misoprostol. The incidence of antibiotic therapy was investigated. Methods: A retrospective descriptive study was performed. Second trimester TOP with misoprostol occurring between January 2008 and October 2012 were selected. We included 403 cases and determined the incidence of fever. To exclude an infection as a probable cause for fever, reports of pathological examination of the placentas were reviewed for signs of infections. In addition, results of blood, vagina and urine cultures were noted. The use of epidural analgesia was noted. Statistical analysis was performed using non-parametric tests and logistic regression. Results: An incidence of 41% fever was found. A dose dependent relation was found between misoprostol and the presence of fever (logistic regression: p < 0.01; OR: 1,859; 95% CI: 1,258-2,746). The effect of epidural analgesia was not significant (p = 0.123; OR 0,317; 95% CI: 0,074-1,365). There was a significant relation between misoprostol and mean highest temperature, which was significantly higher in increased administered doses of misoprostol (p < 0.01). In patients with fever, 4% of the placentas showed signs of infection. None of the blood, urine or vaginal cultures showed a possible cause for fever. Antibiotic therapy was initiated in 19% of the patients with fever. Conclusion: Administration of misoprostol for the indication TOP is highly associated with fever during labor. In the majority of cases the presence of fever is a side effect and not a sign of an IUI. Therefore, antibiotic therapy is not indicated in most cases.

Tocolysis compared with no tocolysis in women with threatened preterm birth and ruptured membranes: a propensity score analysis

Introduction: In women with preterm ruptured membranes and contractions, the administration of tocolysis is controversial. This study compares tocolysis with no tocolysis in women with threatened preterm birth and ruptured membranes. Objective: To compare tocolysis with no tocolysis in women with threatened preterm birth and ruptured membranes. Study design: Data from the APOSTEL III RCT was combined with data from the National Maternity Hospital, Dublin. In the APOSTEL III trial, women with threatened preterm birth were randomized to atosiban or nifedipine. Patient data from Ireland were obtained from a cohort of women with threatened preterm birth with ruptured membranes. The Irish women received no tocolytic treatment. Only women with ruptured membranes and contractions were selected. We studied women with singleton or twin pregnancies and a gestational age between 25+0 and 33+6 weeks. Propensity score matching was performed to create comparable groups. Primary outcome was a composite adverse neonatal outcome. Secondary outcomes were individual components of the primary outcome, as well as neonatal intensive care unit (NICU) admission, gestational age at delivery, prolongation of pregnancy and mode of delivery. Results: 153 women from the Apostel III trial were compared with 51 eligible women of the Irish cohort. We could match 46 women who received tocolysis and 46 women who received no tocolysis. All women had ruptured membranes. Maternal age, BMI, parity and gestational age at study entry were comparable between the groups after matching. There were no statistically significant differences in neonatal composite outcome (9.6 % in the tocolysis group versus 18 % in the control group, OR 0.46, 95 % CI 0.13−1.63). We found a lower incidence of NICU admission in the tocolysis group (63 %) than in the control group (94 %; OR 0.11, 95 % CI 0.03−0.41), which could be explained by differences in national admission policies. There were no statistically significant differences between tocolysis and no tocolysis in any of the other outcomes including sepsis, gestational age at delivery and time to delivery. Conclusion: In this propensity score analysis of women with threatened preterm birth and ruptured membranes, tocolytic therapy did not alter composite adverse neonatal outcome or time to delivery.T.M.S. van Winden, C. Roos, T.A.J. Nijman, C.E. Kleinrouweler, Adriana Olaru, B.W. Mol, F.M. McAuliffe, E. Pajkrt, M.A. Oudij

Cost effectiveness of nifedipine compared with atosiban in the treatment of threatened preterm birth (APOSTEL III trial)

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Low dose aspirin in the prevention of recurrent spontaneous preterm labour the APRIL study: a multicenter randomized placebo controlled trial

Research into fetal development and medicin

Evaluation of low-dose aspirin in the prevention of recurrent spontaneous preterm labour (the APRIL study): A multicentre, randomised, double-blinded, placebo-controlled trial

BackgroundPreterm birth is the leading cause of neonatal morbidity and mortality. The recurrence rate of spontaneous preterm birth is high, and additional preventive measures are required. Our objective was to assess the effectiveness of low-dose aspirin compared to placebo in the prevention of preterm birth in women with a previous spontaneous preterm birth.Methods and findingsWe performed a parallel multicentre, randomised, double-blinded, placebo-controlled trial (the APRIL study). The study was performed in 8 tertiary and 26 secondary care hospitals in the Netherlands. We included women with a singleton pregnancy and a history of spontaneous preterm birth of a singleton between 22 and 37 weeks. Participants were randomly assigned to aspirin 80 mg daily or placebo initiated between 8 and 16 weeks of gestation and continued until 36 weeks or delivery. Randomisation was computer generated, with allocation concealment by using sequentially numbered medication containers. Participants, their healthcare providers, and researchers were blinded for treatment allocation. The primary outcome was preterm birth grade 1, intraventricular hemorrhage > grade 2, necrotising enterocolitis > stage 1, retinopathy of prematurity, culture proven sepsis, or perinatal death). Analyses were performed by intention to treat.From May 31, 2016 to June 13, 2019, 406 women were randomised to aspirin (n = 204) or placebo (n = 202). A total of 387 women (81.1% of white ethnic origin, mean age 32.5 +/- SD 3.8) were included in the final analysis: 194 women were allocated to aspirin and 193 to placebo. Preterm birth 80% medication adherence, preterm birth occurred in 24 (19.2%) versus 30 (24.8%) women (RR 0.77, 95% CI 0.48 to 1.25, p = 0.29). The rate of the composite of poor neonatal outcome was 4.6% (n = 9) versus 2.6% (n = 5) (RR 1.79, 95% CI 0.61 to 5.25, p = 0.29). Among all randomised women, serious adverse events occurred in 11 out of 204 (5.4%) women allocated to aspirin and 11 out of 202 (5.4%) women allocated to placebo. None of these serious adverse events was considered to be associated with treatment allocation. The main study limitation is the underpowered sample size due to the lower than expected preterm birth rates.ConclusionsIn this study, we observed that low-dose aspirin did not significantly reduce the preterm birth rate in women with a previous spontaneous preterm birth. However, a modest reduction of preterm birth with aspirin cannot be ruled out. Further research is required to determine a possible beneficial effect of low-dose aspirin for women with a previous spontaneous preterm birth