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For a long time, the reliability of medical-scientific research was, without further verification, based on real data. It is becoming increasingly clear that this assumption is unjustified and that probably at least 25% of published randomized clinical trials are based on unreliable and sometimes even fabricated data. After giving a number of examples, it is discussed what the reader can do about this problem. More importantly, editors and publishers should no longer rely on whistle-blowers but take action themselves. If this does not happen, external parties must intervene. Society cannot afford (medical) science that is based on unreliable data.

Objective: To survey (a) the frequency of the use of patient-controlled analgesic remifentanil-PCA during labour in the Netherlands; (b) considerations by obstetricians whether or not to offer remifentanil-PCA; (c) target population for remifentanil-PCA and (d) the application of maternal monitoring., Design: Descriptive survey., Method: A questionnaire was sent to all 81 Dutch hospitals with a labour ward. The following subjects were covered: (a) available methods for pharmacological pain relief; (b) considerations by obstetricians whether or not to offer remifentanil-PCA; (c) target population for remifentanil-PCA; (d) maternal monitoring and (e) the hospital's birth data for the year 2016. The hospital pharmacist was asked for the number of remifentanil dispensed in 2016-2017., Results: The questionnaire was completed by 81 obstetricians (100% response rate). Remifentanil-PCA was available in 59 out of 81 (73%) of the hospitals with a mean use of 23% of the births (range 16-56%) in those units. In 34 (58%) of these hospitals, remifentanil-PCA is available for all women, and in 25 (42%) it was for a selected group of women. Most frequently mentioned considerations for offering remifentanil-PCA were 'a need for an alternative for epidural analgesia' and 'at the request of pregnant women' reported a respective 55 (93%) and 46 (78%) times. In hospitals where remifentanil-PCA was not offered, the following motives were given for this policy: 'epidural analgesia is the most effective method of pain relief during labour'; 'risk of serious maternal complications'; and 'sufficient monitoring during labour not feasible in delivery rooms'., Conclusion: A large variation between Dutch hospitals exists in the application of remifentanil-PCA during labour. In the majority of the hospitals, remifentanil-PCA is available for all women. The most common motives mentioned by obstetricians for its use are 'a need for an alternative for epidural analgesia' and 'at the request of pregnant women'.

Objective: To assess adherence to expectant management of 6-12 months in couples with unexplained subfertility, as recommended by the Dutch Networkguideline Subfertility., Design: A retrospective cohort study in 25 clinics., Method: Couples were eligible to participate if they were diagnosed with unexplained subfertility and had a good prognosis of natural conception within one year (>30%), for these couples the network guideline recommends an expectant management. Outcomes measures are overtreatment, i.e. couples that started treatment within six months, and three quality indicators: 1) prognosis not calculated, 2) no correct expectant management advised, 3) starting treatment too soon despite a correct advise. Data collection was obtained from medical records. Multilevel regression analyses were performed to investigate associations of overtreatment with patient and clinic characteristics., Results: We included 544 couples. Overtreatment occurred in 36% (N=198). In 34% (N=186) of all couples no prognosis was calculated (1), and in 42% (N=230) of all couples expectant management was not advised correctly (2). When a correct expectant management of six to twelve months was advised, 16% (N=51) started treatment too soon anyway. Overtreatment occurred more frequently in childless couples, a higher female age, and a longer duration of infertility., Conclusion: Our findings show that developing and publishing guideline recommendations on expectant management is not enough and that overtreatment still occurs frequently. To improve future care the next step is to evaluate a tailored implementation strategy to improve adherence to the recommendations on expectant management by the Dutch Networkguideline Subfertility.

Objective: To analyse if from 2000-2010 the rate of elective caesarean sections (CS) before 39 0/7 weeks of gestation declined when compared with all elective CS, and to evaluate the possible associated factors., Design: Retrospective cohort study., Method: Using data from The Netherlands Perinatal Registry, all term elective CS (n = 59,653) from 2000-2010 were selected. Trends in patient characteristics and in performing an elective CS before 39 0/7 weeks were analysed using regression analysis, and differences between hospitals using the χ2 test. Using multiple logistic regression analysis it was analysed which factors were associated with performing an elective CS before 39 0/7 weeks., Results: The percentage of elective CS before 39 0/7 weeks decreased from 56% in 2000 to 43% in 2010 (p < 0.0001). In peripheral hospitals an elective SC was performed more often before 39+0 weeks than in academic hospitals; 53% in peripheral teaching hospitals, 57% in peripheral non-teaching hospitals, and 46% in academic hospitals. Adjusted odds ratios and 95% confidence intervals were 1.38 (1.30-1.47) in peripheral teaching hospitals, and 1.55 (1.46-1.65) in peripheral non-teaching hospitals. In hospitals where the number of deliveries per year was situated in the lower quartile, elective CS before 39 0/7 weeks was carried out more often than in hospitals where deliveries per year were in the upper quartile, 60% versus 52% (p < 0.0001)., Conclusion: In the period 2000-2009 the timing of elective CS improved marginally. In 2010 the trend began to decline, even though 43% of elective caesarean sections were still carried out before 39 0/7 weeks. This results in a higher risk of neonatal morbidity and health problems in long-term.

Obesity can lead to anovulation and subfertility. Around the world fertility treatment is withheld from women above a certain BMI, ranging from 25 to 40 kg/m2. The proponents of this policy use three different arguments to justify their restrictions: risks to the woman, health and wellbeing of the future child, and importance for society. In this article we critically appraise these arguments. In conclusion, we think obese women should be informed about the consequences of their weight on fertility and pregnancy complications and encouraged to lose weight. If, however, a woman is unable to lose weight despite effort, we feel there is no argument to withhold treatment from her. This would be unjustified with respect to the treatment of other women with a high risk of complications.

Compared with other countries, the elective caesarean section rate for twins is relatively low in the Netherlands. Worldwide, there is an increasing trend toward performing more elective caesarean sections for women with a twin pregnancy at term, be it for twins with the first child in breech or in cephalic presentation. The results of the 'Twin Birth Study' indicate that a planned caesarean section does not improve outcome as compared with planned vaginal birth for twins with the first child in cephalic position beyond 32 weeks gestation. During the study, an experienced obstetrician was present during planned vaginal delivery and there was a possibility of performing a secondary caesarean section within 30 minutes. This study provides an additional argument to guarantee the aforementioned conditions in all hospitals where women plan to deliver their twins vaginally. However, the definition of an experienced obstetrician is subject to debate.

Objective: To gain an insight into the costs and health outcomes of effectiveness studies in obstetrics at a national level., Design: Budget impact analysis., Method: We searched for obstetric effectiveness studies. The possible budget impact of implementation in all patients in the Netherlands was calculated, as well as health benefits for mothers and their children., Results: We used eight multicentre randomized trials with almost 11,000 patients in total. The total potential cost reduction for these trials was € 9.6 million per year, on the basis of a one-time investment in the trials of € 3.1 million. When implementing the results of these studies, a health benefit is shown in women with hypertension or pre-eclampsia at term, women in whom labour is induced and women with fetal monitoring. This also applied to the children of these women. Furthermore, removal or non-implementation of interventions that have no positive effect on health such as prolonged tocolysis, the use of progestogens in twin pregnancies, intrauterine pressure catheters, and induction of labour in preterm ruptured membranes reduces care costs., Conclusion: Adequate application of the results of effectiveness studies in obstetrics should result in considerable health gains and cost reduction when compared with provision of non-scientifically supported care.

Randomised clinical trials are the preferred tool to assess the effectiveness of new treatment strategies and to compare the effectiveness of existing techniques. Since it is virtually impossible to complete studies with the required sample sizes in a single centre or even a few centres, from 2003 onwards 70 Dutch hospitals have since joined forces in the initiation and execution of large clinical studies. The consortia address pragmatic questions in the fields of obstetrics, gynaecology and reproductive medicine. The construction of a common infrastructure for ethical approval, recruitment of patients, data management and analysis is central to this collaboration. Research nurses and midwives play a key role in the recruitment of participants and the collection of data. In this article we consider if in view of the results obtained, funding from government and insurance companies and the participation of health care providers can continue to be as liberal as it has been up to now.

Objective: To evaluate whether the speed at which multicenter studies can be launched in the Netherlands has been improved by the new External Review Directive., Design: Cohort study., Method: We studied the time between requesting and granting a declaration of local feasibility of 7 multicenter studies under the new External Review Directive, which came into effect on 1 March 2012. We distinguished between centres that complied with the new directive and those that did not. We also compared the time to approval of local feasibility of these 7 studies with those of 13 studies that were launched under the old directive., Results: Under the new procedure, the median time between issue of the approval letter by the primary evaluative centre and approval by the Board of Directors of the participating centre was 93 days: 50 days for centres that performed the procedure in accordance with the directive (31 applications) and 118 days for centres that did not perform the review in accordance with the new directive (79 applications). This difference was significant (log rank test; p = 0.003). Under the old procedure, the median time to approval was 103 days (336 applications)., Conclusion: The new External Review Directive for multicenter studies provides a significant improvement in time to approval of local feasibility for multicenter trials in centres that commit to the new directive. However, the majority of hospitals have not yet complied with this directive, which still delays studies unnecessarily.

More than 10 years after its first introduction, robot-assisted surgery is now performed in 17 Dutch hospitals. Robotic-assisted radical prostatectomy (RARP) is the most frequently performed, though its clinical superiority compared to open (RRP) and laparoscopic prostatectomy (LRP) has not been demonstrated. One randomized controlled trial showed better outcome in erectile function after RARP compared to LRP. The quality of the other studies into RARP is too limited to draw reliable conclusions on clinically relevant outcome measures such as survival, disease-free survival and quality of life. Given the high costs and small scientific evidence, the introduction of robotic surgery has been irresponsibly quick. Better scientific research of robotic surgery is needed before this technology can be broadly applied in clinical practice.

Hypothyroidism and hyperthyroidism are associated with maternal and neonatal pregnancy complications. Hypothyroidism should be treated with levothyroxine. Hyperthyroidism requires treatment with propylthiouracil or thiamazole. Subclinical hypothyroidism and thyroid auto-immunity are also associated with maternal and neonatal pregnancy complications. For both subclinical hypothyroidism and thyroid auto-immunity, treatment with levothyroxine has not yet been proven to be effective in preventing complications during pregnancy. For the Dutch population the following reference values for TSH levels during pregnancy may be used: 0.01-4.00 mU/l in the first and second trimesters. Reference values for the third trimester have not reported for this population, but are probably comparable with those of the second trimester.

The Royal Dutch Organization of Midwives (KNOV) recently presented their practice guideline 'Anaemia in midwifery practice'. The guideline identified available evidence on diagnosis, prognosis and treatment of anaemia in pregnancy. Anaemia based on iron deficiency and subsequent treatment with iron supplementation are probably the most frequent aspects of care for pregnant women. However, there is surprisingly enough no evidence of the efficacy of iron supplementation treatment on relevant clinical outcomes in pregnant women with anaemia. We plead to make the next guideline a multidisciplinary one. Such a guideline may lead to a large pragmatic trial evaluating the efficacy of iron supplementation treatment for patients with anaemia.

Recent studies show that higher blood glucose values after a 75 g oral glucose tolerance test in pregnancy are associated with higher rates of perinatal and maternal complications. Treatment of gestational diabetes mellitus (hyperglycaemia in pregnancy) reduces the risk of complications. Gestational diabetes mellitus is an asymptomatic condition. Screening is the only strategy for diagnosing this disorder of pregnancy in time, in order to provide treatment. Until recently, there was no uniformity concerning diagnostic strategy and treatment of gestational diabetes mellitus in the Netherlands, possibly due to lack of evidence on the risk of complications and the effectiveness of treatment. Results of several recent studies show that early detection and treatment of gestational diabetes mellitus are effective. By means of a more active screening and treatment policy it should be possible to reduce the perinatal and maternal complications as a result of gestational diabetes mellitus.

Objective: To investigate differences in perinatal mortality between Dutch provinces and to determine the significance of risk factors including travel time from home to the hospital during labour., Design: Cohort study., Method: The study was based on 1,242,725 singleton births in 2000-2006 as recorded in the Netherlands Perinatal Registry. The influence of province on perinatal mortality was estimated, with logistic regression analysis adjusting for risk factors (age, parity, ethnicity, socioeconomic status) and care factors such as start of antenatal care and travel time., Results: The perinatal mortality rate in the Netherlands was 9.9 per 1000 births. The provinces with the highest mortality rates were Friesland (11.3‰), Groningen (11.1‰), Zeeland (10.6‰) and Flevoland (10.4‰). Noord-Brabant (9.2‰) and Limburg (9.2‰) had the lowest mortality rates. These differences were significantly higher for Friesland (odds ratio: 1.16; 95%-CI: 1.05-1.28) and Groningen (odds ratio: 1.13; 95%-CI: 1.02-1.26). Starting late with perinatal care, at 18 weeks of gestation or later was an important risk factor (adjusted odds ratio 1.8; 95%-CI: 1.7-1.8). Low socio-economic status could partly be associated with the higher mortality risk in Groningen. Longer travel time (≥ 20 minutes) was an independent risk factor associated with perinatal mortality. On average 19% of the women travelled ≥ 20 minutes to the hospital. In the provinces Groningen, Friesland, Flevoland and Zeeland these percentages ranged between 32 and 36%. The adjusted odds ratio of travel time was 1.7 (95%-CI 1.6-1.7)., Conclusion: The perinatal mortality differs per province. This can be explained by longer travel time to the hospital during labour. Late start of perinatal care and low socio-economic status also affect the mortality rate. These risk factors need to be taken into account during registration, investigation, audit and obstetric policy.

At the request of the State Secretary of the Dutch Ministry of Health, Welfare and Sport a national multidisciplinary workgroup developed an evidence-based practice guideline for the management of pregnant women with an imminent preterm delivery after a pregnancy of less than 26 weeks duration and for extremely preterm neonates. Active care measures are advised for neonates from a gestational age of 24 0/7 weeks onwards, unless there are serious arguments that justify a conservative management. In cases of imminent preterm delivery, intrauterine transport to a perinatological care centre is advised from a gestational age of 23 4/7 weeks onwards. In cases of imminent preterm delivery, glucocorticoids to enhance fetal lung maturity should be administered from a gestational age of 23 5/7 weeks onwards. From a gestational age of 24 0/7 weeks onwards a caesarean section may be considered if the fetal condition during spontaneous labour justifies this.

Since the discovery of progesterone researchers have studied whether administration of exogenous progesterone can prevent preterm birth. Two trials were published in 2003 that showed a positive effect of progesterone with regard to the prevention of recurrent preterm birth. However, more recent data do not support these findings. In multiple pregnancies the use of progesterone does not seem to reduce the number of preterm births. The results in pregnant women with asymptomatic shortening of the cervix are promising, although more research is needed in this group.

Objective: To determine the prognostic value of foetal fibronectin and cervical length for predicting imminent preterm labour among Dutch women, who in the Netherlands normally undergo a digital examination of the cervix prior to referral to a hospital or university medical centre., Design: Prospective observational cohort study., Methods: Pregnant women with symptoms of preterm labour and a gestational age between 24 and 34 weeks were included. A fibronectin smear was taken from them and the cervical length was measured. Primary outcome was delivery within 7 days after inclusion. Sensitivity, specificity and a receiver-operating characteristics (ROC) curve were calculated., Results: 13 (12%) of the 108 included patients delivered spontaneously within 7 days after inclusion. The fibronectin test had a sensitivity of 92% and specificity of 60%. The positive and negative predictive values were 27% and 98% respectively. For women who had undergone a digital examination prior to testing, the predictive value was slightly less but the difference was not significant. Although measurement of the cervical length scarcely had a predictive value, none of the patients with a cervical length above 35 mm delivered within 7 days., Conclusion: In women with an imminent preterm labour, a negative fibronectin test virtually ruled out delivery within 7 days. The fibronectin test can therefore also be used in the Dutch situation. In women with a cervix length greater than 35 mm, the chance of a preterm labour within 7 days is very small and a fibronectin test does not need to be performed in their case.

Since the 1970s, intrapartum monitoring of the distressed foetus has been managed by continuous registration of the foetal heart rate, together with uterine activity (cardiotocogram; CTG). Use of CTG without additional foetal information leads to unnecessary interventions because of the high number of false-positive signals. Foetal blood sampling (FBS) is a solution to this problem, but is not always consistently carried out. Automated ST analysis of the foetal electrocardiogram (STAN method), combined with the CTG, may lead to reduction of metabolic acidosis, fewer interventions and fewer foetal blood samples. A disadvantage of application of the STAN method is that it is based on visual interpretation of the CTG, with large inter- and intraobserver variability. In spite of this shortcoming the method may be promising.