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Contains fulltext : 152606.pdf (Publisher’s version ) (Open Access) Objective The aim of this study was to assess which characteristics and results of vaginal examination are predictive for delivery within 7 days, in women with threatened preterm labor after initial treatment. Study Design A secondary analysis of a randomized controlled trial on maintenance nifedipine includes women who remained undelivered after threatened preterm labor for 48 hours. We developed one model for women with premature prelabor rupture of membranes (PPROM) and one without PPROM. The predictors were identified by backward selection. We assessed calibration and discrimination and used bootstrapping techniques to correct for potential overfitting. Results For women with PPROM (model 1), nulliparity, history of preterm birth, and vaginal bleeding were included in the multivariable analysis. For women without PPROM (model 2), maternal age, vaginal bleeding, cervical length, and fetal fibronectin (fFN) status were in the multivariable analysis. Discriminative capability was moderate to good (c-statistic 0.68; 95% confidence interval [CI] 0.60-0.77 for model 1 and 0.89; 95% CI, 0.84-0.93 for model 2). Conclusion PPROM and vaginal bleeding in the current pregnancy are relevant predictive factors in all women, as are maternal age, cervical length, and fFN in women without PPROM and nulliparity, history of preterm birth in women with PPROM.

We evaluated the methodological quality of economic evaluation studies in the field of obstetrics and gynecology published in the last decade. A MEDLINE search was performed to find economic evaluation studies in obstetrics and gynecology from the years 1997 through 2009. We included full economic evaluation studies concerning tests or interventions in the field of obstetrics or gynecology. Each included study was evaluated by two reviewers using a quality checklist that was based on international guidelines for medical economic evaluation studies and a checklist used in a previous review. The mean number of quality criteria adhered to was 23 of 30 items, whereas five articles (3%) met all 30 criteria. Compliance was low for the description of the perspective (40%), the completeness of costs looking at the perspective (48%) or time horizon (48%), and reporting of quantities of resources (47%). Furthermore, if no discounting was applied, an explanation was infrequently given (14%). A comparison of study quality to that reported by Smith and Blackmore showed a considerable improvement in the following criteria: presentation perspective (from 19 to 40%), statement of primary outcome measure (from 72 to 81%), completeness costs looking at the time horizon (from 14 to 48%), the presentation of discount rates (from 10 to 54%), details of sensitivity analyses (from 21 to 61%), reporting incremental results (from 17 to 70%), and reporting a summary measure (from 57 to 74%). The quality of economic studies in obstetrics and gynecology has considerably improved in the last decade, but room for further improvement is present.

Objective To assess the cost-effectiveness of addition of ST analysis of the fetal electrocardiogram (ECG; STAN) to cardiotocography (CTG) for fetal surveillance during labor compared with CTG only. Design Cost-effectiveness analysis based on a randomized clinical trial on ST analysis of the fetal ECG. Setting Obstetric departments of three academic and six general hospitals in The Netherlands. Population. Laboring women with a singleton high-risk pregnancy, a fetus in cephalic presentation, a gestational age >36 weeks and an indication for internal electronic fetal monitoring. Methods A trial-based cost-effectiveness analysis was performed from a health-care provider perspective. Main outcome measures Primary health outcome was the incidence of metabolic acidosis measured in the umbilical artery. Direct medical costs were estimated from start of labor to childbirth. Cost-effectiveness was expressed as costs to prevent one case of metabolic acidosis. Results The incidence of metabolic acidosis was 0.7% in the ST-analysis group and 1.0% in the CTG-only group (relative risk 0.70; 95% confidence interval 0.38-1.28). Per delivery, the mean costs per patient of CTG plus ST analysis (n= 2 827) were €1,345 vs. €1,316 for CTG only (n= 2 840), with a mean difference of €29 (95% confidence interval -€9 to €77) until childbirth. The incremental costs of ST analysis to prevent one case of metabolic acidosis were €9 667. Conclusions The additional costs of monitoring by ST analysis of the fetal ECG are very limited when compared with monitoring by CTG only and very low compared with the total costs of delivery.

Although induction of labor in pregnant women at term with gestational hypertension or mild preeclampsia is already recommended and practiced in the United States and other developed countries, no randomized clinical trials have been carried out comparing induction of labor versus expectant monitoring. This multicenter, parallel, randomized, unblinded controlled trial compared the effect of labor induction or expectant management on maternal morbidity in singleton women with gestational hypertension or mild preeclampsia at term. A total of 776 women were randomized to undergo induction of labor (n = 377) or expectant monitoring (n = 379). The study was conducted between 2005 and 2008 at 38 hospitals in the Netherlands. The primary outcome measure was a composite of adverse maternal outcomes: maternal mortality, maternal morbidity (eclampsia, HELLP syndrome, pulmonary edema, thromboembolic disease, or placental abruption), progression to severe disease or proteinuria, and major postpartum hemorrhage (blood loss of more than 1000 mL within 24 hour of delivery). Data were analyzed according to an intention-to-treat basis. The composite adverse primary outcome occurred in fewer women who were induced compared to those receiving expectant monitoring (31% [117/377] vs. 44% [166/379]; the relative risk was 0.71, with a 95% confidence interval of 0.59-0.86, P < 0.0001). No fetal or neonatal deaths or cases of eclampsia or placental abruption occurred in either group. The investigators conclude from these findings that women with mild hypertensive disease beyond 37 weeks' gestation should be advised to undergo induction.

Background Preterm labour is the main cause of perinatal morbidity and mortality in the Western world. At present, there is evidence that tocolysis for 48 hours is useful in women with threatened preterm labour at least before 32 weeks. This allows transfer of the patient to a perinatal centre, and maximizes the effect of corticosteroids for improved neonatal survival. It is questionable whether treatment with tocolytics should be maintained after 48 hours. Methods/Design The APOSTEL II trial is a multicentre placebo-controlled study. Pregnant women admitted for threatened preterm labour who have been treated with 48 hours corticosteroids and tocolysis will be eligible to participate in the trial between 26+0 and 32+2 weeks gestational age. They will be randomly allocated to nifedipine (intervention) or placebo (control) for twelve days or until delivery, whatever comes first. Primary outcome is a composite of perinatal death, and severe neonatal morbidity up to evaluation at 6 months after birth. Secondary outcomes are gestational age at delivery, number of days in neonatal intensive care and total days of the first 6 months out of hospital. In addition a cost-effectiveness analysis will be performed. Analysis will be by intention to treat. The power calculation is based on an expected 11% difference in adverse neonatal outcome. This implies that 406 women have to be randomised (two sided test, β 0.2 at alpha 0.05). Discussion This trial will provide evidence as to whether maintenance tocolysis reduces severe perinatal morbidity and mortality in women with threatened preterm labour before 32 weeks. Trial Registration Clinical trial registration: http://www.trialregister.nl, NTR 1336, date of registration: June 3rd 2008.

Background In nursing homes there is a gradual move from traditional care to integrated care. Integrated care means a demand-oriented, small-scale, co-operated and coordinated provision of services by different caregivers. This integration has direct effect on the work of these separate disciplines. With the introduction of integrated care the quality of work of these caregivers should be assured or even be improved. Objectives The purpose of this study was to examine the implementation of integrated care in the nursing home sector and its effects on the quality of work of the caregivers (work content, communication and co-operation and worker's outcomes). Design A non-equivalent pre-test/post-test control group design was used in this study. Settings and participants Two nursing homes in the Netherlands participated in the study. One nursing home provided the five experimental nursing wards and the other nursing home provided four control wards. Method Data were selected by means of written questionnaires. Results The results showed that the intervention appeared to be only successful on the somatic wards. The caregivers of these wards were more able to create a home-like environment for their residents, to use a demand-oriented working method and to integrate the provision of care and services. Regarding the effects of the intervention on quality of work factors, the results included an increase of social support by the supervisor, an increase of the degree of collaboration and a decrease in job demands. No changes were found for the worker's outcomes such as job satisfaction. Conclusions The intervention on the psycho-somatic wards was unsuccessful. Although the introduction of integrated care on the somatic wards was successful, the effects on quality of work were limited. Next to quantitative research, more qualitative in-depth research is needed to examine models of integrated care and their effects on the work of caregivers within health care organisations, with special attention for specific characteristics of different types of nursing home care (somatic vs. psycho-geriatric).

Objective To evaluate the methodologic quality of economic analyses published in the field of reproductive medicine. Design Systematic review. Setting Centers for reproductive care. Patient(s) Infertility patients. Intervention(s) We performed a Medline search to identify economic evaluation studies in reproductive medicine. We included studies that concerned interventions, evaluated costs and effects, and were published in a journal on reproductive medicine, gynecology, or a major general journal from 1997 through May 2011. Main Outcome Measure(s) Number of quality criteria adhered to. Result(s) Our search revealed 5,519 articles, of which 85 met our inclusion criteria. Seventy-seven (91%) of the economic analyses were on treatment, six (7%) on diagnosis, and two (2%) on screening. The mean number of quality criteria adhered to was 20 out of 30 items, and only one article met all 30 criteria. The mean number of criteria adhered to was higher if at least one of the authors was from a methodologic or health economics department (mean 23 [n = 30] versus mean 20 [n = 55]). The most common limitations of published economic evaluation studies were in methodology or presentation of incremental analyses, sensitivity analyses, and discounting. Conclusion(s) Economic analyses published in the past 15 years in the field of reproductive medicine seldom adhere to all recommended methodologic standards. A large majority of these publications evaluated treatments rather than diagnostic interventions.