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However, long-term use and high doses may lead to nephrotoxicity. It is unclear whether serum trough levels may be useful for monitoring this risk, similar to patients on cyclosporine for [...]

Objective: To evaluate the effectiveness of hysteroscopy for the detection and treatment of endometrial polyps versus expectant management in women with postmenopausal bleeding (PMB), a thickened endometrium and benign endometrial sampling.Design: Multicentre, randomised controlled trial.Setting: Three academic hospitals and nine non-academic teaching hospitals in the Netherlands.Population: Women with PMB, an endometrial thickness >4 mm and benign result from endometrial sampling.Methods: Women were randomised to either further diagnostic workup by hysteroscopy (preceded by saline infusion sonography) or expectant management.Main Outcomes: The primary outcome measure was recurrence of PMB within a year after randomisation. Secondary outcome measures were time to recurrent bleeding and recurrent bleeding after more than 1 year. In the hysteroscopy group, the presence of polyps and the results of their histology were registered.Results: Between January 2010 and October 2013, 200 women were randomised; 98 to hysteroscopy and 102 to expectant management. Within 1 year a total of 15 women (15.3%) in the hysteroscopy group experienced recurrent bleeding, versus 18 (18.0%) in the expectant management group (relative risk 0.85 (95% CI 0.46-1.59). In the hysteroscopy group, 50/98 (51%) polyps were diagnosed of which 6/98 (6%) showed evidence of endometrial (pre)malignancy; final pathology results after hysterectomy showed three women with hyperplasia with atypia and three women with endometrial cancer.Conclusion: In women with PMB, a thickened endometrium and benign endometrial sampling, operative hysteroscopy does not reduce recurrent bleeding. Hysteroscopy detected focal endometrial (pre)malignancy in 6% of women who had benign endometrial sampling. This finding indicates that in these women, further diagnostic workup is warranted to detect focal (pre)malignancies, missed by blind endometrial sampling.Tweetable Abstract: In women with PMB, hysteroscopy does not reduce recurrent bleeding but is warranted to detect focal malignancy. [ABSTRACT FROM AUTHOR]

Objective To assess the economic consequences of labour induction with Foley catheter compared to prostaglandin E2 gel. Design Economic evaluation alongside a randomised controlled trial. Setting Obstetric departments of one university and 11 teaching hospitals in the Netherlands. Population Women scheduled for labour induction with a singleton pregnancy in cephalic presentation at term, intact membranes and an unfavourable cervix; and without previous caesarean section. Methods Cost-effectiveness analysis from a hospital perspective. Main outcome measures We estimated direct medical costs associated with healthcare utilisation from randomisation to 6 weeks postpartum. For caesarean section rate, and maternal and neonatal morbidity we calculated the incremental cost-effectiveness ratios, which represent the costs to prevent one of these adverse outcomes. Results Mean costs per woman in the Foley catheter group ( n = 411) and in the prostaglandin E2 gel group ( n = 408), were €3297 versus €3075, respectively, with an average difference of €222 (95% confidence interval −€157 to €633). In the Foley catheter group we observed higher costs due to longer labour ward occupation and less cost related to induction material and neonatal admissions. Foley catheter induction showed a comparable caesarean section rate compared with prostaglandin induction, therefore the incremental cost-effectiveness ratio was not informative. Foley induction resulted in fewer neonatal admissions (incremental cost-effectiveness ratio €2708) and asphyxia/postpartum haemorrhage (incremental cost-effectiveness ratios €5257) compared with prostaglandin induction. Conclusions Foley catheter and prostaglandin E2 labour induction generate comparable costs. [ABSTRACT FROM AUTHOR]

Importance: In threatened preterm labor, maintenance tocolysis with nifedipine, after an initial course of tocolysis and corticosteroids for 48 hours, may improve perinatal outcome.Objective: To determine whether maintenance tocolysis with nifedipine will reduce adverse perinatal outcomes due to premature birth.Design, Setting, and Participants: APOSTEL-II (Assessment of Perinatal Outcome with Sustained Tocolysis in Early Labor) is a double-blind, placebo-controlled trial performed in 11 perinatal units including all tertiary centers in The Netherlands. From June 2008 to February 2010, women with threatened preterm labor between 26 weeks (plus 0 days) and 32 weeks (plus 2 days) gestation, who had not delivered after 48 hours of tocolysis and a completed course of corticosteroids, were enrolled. Surviving infants were followed up until 6 months after birth (ended August 2010).Intervention: Randomization assigned 406 women to maintenance tocolysis with nifedipine orally (80 mg/d; n = 201) or placebo (n = 205) for 12 days. Assigned treatment was masked from investigators, participants, clinicians, and research nurses.Main Outcome Measures: Primary outcome was a composite of adverse perinatal outcomes (perinatal death, chronic lung disease, neonatal sepsis, intraventricular hemorrhage >grade 2, periventricular leukomalacia >grade 1, or necrotizing enterocolitis). Analyses were completed on an intention-to-treat basis.Results: Mean (SD) gestational age at randomization was 29.2 (1.7) weeks for both groups. Adverse perinatal outcome was not significantly different between groups: 11.9% (24/201; 95% CI, 7.5%-16.4%) for nifedipine vs 13.7% (28/205; 95% CI, 9.0%-18.4%) for placebo (relative risk, 0.87; 95% CI, 0.53-1.45).Conclusions and Relevance: In patients with threatened preterm labor, nifedipine-maintained tocolysis did not result in a statistically significant reduction in adverse perinatal outcomes when compared with placebo. Although the lower than anticipated rate of adverse perinatal outcomes in the control group indicates that a benefit of nifedipine cannot completely be excluded, its use for maintenance tocolysis does not appear beneficial at this time.Trial Registration: trialregister.nl Identifier: NTR1336. [ABSTRACT FROM AUTHOR]

Objective To develop a clinical prediction rule that can help the clinician to identify women at high and low risk for gestational diabetes mellitus (GDM) early in pregnancy in order to improve the efficiency of GDM screening. Design We used data from a prospective cohort study to develop the clinical prediction rule. Setting The original cohort study was conducted in a university hospital in the Netherlands. Population Nine hundred and ninety-five consecutive pregnant women underwent screening for GDM. Methods Using multiple logistic regression analysis, we constructed a model to estimate the probability of development of GDM from the medical history and patient characteristics. Receiver operating characteristics analysis and calibration were used to assess the accuracy of the model. Main outcome measure The development of a clinical prediction rule for GDM. We also evaluated the potential of the prediction rule to improve the efficiency of GDM screening. Results The probability of the development of GDM could be predicted from the ethnicity, family history, history of GDM and body mass index. The model had an area under the receiver operating characteristic curve of 0.77 (95% CI 0.69–0.85) and calibration was good (Hosmer and Lemeshow test statistic, P = 0.25). If an oral glucose tolerance test was performed in all women with a predicted probability of 2% or more, 43% of all women would be tested and 75% of the women with GDM would be identified. Conclusions The use of a clinical prediction model is an accurate method to identify women at increased risk for GDM, and could be used to select women for additional testing for GDM. [ABSTRACT FROM AUTHOR]

Context: In patients with severe secondary peritonitis, there are 2 surgical treatment strategies following an initial emergency laparotomy: planned relaparotomy and relaparotomy only when the patient's condition demands it ("on-demand"). The on-demand strategy may reduce mortality, morbidity, health care utilization, and costs. However, randomized trials have not been performed.Objective: To compare patient outcome, health care utilization, and costs of on-demand and planned relaparotomy.Design, Setting, and Patients: Randomized, nonblinded clinical trial at 2 academic and 5 regional teaching hospitals in the Netherlands from November 2001 through February 2005. Patients had severe secondary peritonitis and an Acute Physiology and Chronic Health Evaluation (APACHE-II) score of 11 or greater.Intervention: Random allocation to on-demand or planned relaparotomy strategy.Main Outcome Measures: The primary end point was death and/or peritonitis-related morbidity within a 12-month follow-up period. Secondary end points included health care utilization and costs.Results: A total of 232 patients (116 on-demand and 116 planned) were randomized. One patient in the on-demand group was excluded due to an operative diagnosis of pancreatitis and 3 in each group withdrew or were lost to follow-up. There was no significant difference in primary end point (57% on-demand [n = 64] vs 65% planned [n = 73]; P = .25) or in mortality alone (29% on-demand [n = 32] vs 36% planned [n = 41]; P = .22) or morbidity alone (40% on-demand [n = 32] vs 44% planned [n = 32]; P = .58). A total of 42% of the on-demand patients had a relaparotomy vs 94% of the planned relaparotomy group. A total of 31% of first relaparotomies were negative in the on-demand group vs 66% in the planned group (P <.001). Patients in the on-demand group had shorter median intensive care unit stays (7 vs 11 days; P = .001) and shorter median hospital stays (27 vs 35 days; P = .008). Direct medical costs per patient were reduced by 23% using the on-demand strategy.Conclusion: Patients in the on-demand relaparotomy group did not have a significantly lower rate of death or major peritonitis-related morbidity compared with the planned relaparotomy group but did have a substantial reduction in relaparotomies, health care utilization, and medical costs.Trial Registration: http://isrctn.org Identifier: ISRCTN51729393. [ABSTRACT FROM AUTHOR]