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Objective: To assess the effect on mode of delivery of the routine use of labour epidural analgesia (EA) compared with analgesia on request., Design: Randomised non-inferiority trial., Setting: One university and one non-university teaching hospital in The Netherlands., Population: Women with a singleton pregnancy in cephalic presentation beyond 36 + 0 weeks' gestation., Methods: Participants were randomly allocated to receive either routine EA or analgesia on request. Intention-to-treat (ITT) and per-protocol (PP) analyses were performed, with confidence intervals (CI) calculated for the differences in percentages or means., Main Outcome Measures: Rate of operative delivery (instrumental vaginal or caesarean), labour characteristics, and adverse labour and neonatal outcomes., Results: A total of 488 women were randomly allocated to the routine EA (n = 233) or analgesia on request group (n = 255). In the routine EA group, 89.3% (208/233) received EA. According to ITT analysis, 34.8% (81/233) women in the routine EA group had an operative delivery, compared with 26.7% (68/255) in the analgesia on request group (difference 8.1%, 95% CI -0.1 to 16.3). The difference in rate of operative deliveries according to the PP analysis was statistically significant (difference 8.9%, 95% CI 0.4 to 17.4). Inferiority of EA could not be rejected, as in both analyses the upper bound of the confidence interval exceeded the pre-specified inferiority criterion of +10%. Women in the routine EA group had more adverse effects, including hypotension (difference 9.5%, 95% CI 4.2 to 14.9), and motor blockade (difference 6.8%, 95% CI 1.1 to 12.5)., Conclusion: Non-inferiority of routine EA could not be demonstrated in this trial. Routine EA use is likely to lead to more operative deliveries and more maternal adverse effects. The results of our study do not justify routine use of EA., (© 2014 Royal College of Obstetricians and Gynaecologists.)

Objective: To assess the effect of red blood cell (RBC) transfusion on quality of life in acutely anaemic women after postpartum haemorrhage., Design: Randomised non-inferiority trial., Setting: Thirty-seven Dutch university and general hospitals., Population: Women with acute anaemia (haemoglobin 4.8-7.9 g/dl [3.0-4.9 mmol/l] 12-24 hours postpartum) without severe anaemic symptoms or severe comorbidities., Methods: Women were allocated to RBC transfusion or non-intervention., Main Outcome Measures: Primary outcome was physical fatigue 3 days postpartum (Multidimensional Fatigue Inventory, scale 4-20; 20 represents maximal fatigue). Non-inferiority was demonstrated if the physical fatigue difference between study arms was maximal 1.3. Secondary outcomes were health-related quality of life and physical complications. Health-related quality of life questionnaires were completed at five time-points until 6 weeks postpartum., Results: In all, 521 women were randomised to non-intervention (n = 262) or RBC transfusion (n = 259). Mean physical fatigue score at day 3 postpartum, adjusted for baseline and mode of delivery, was 0.8 lower in the RBC transfusion arm (95% confidence interval: 0.1-1.5, P = 0.02) and at 1 week postpartum was 1.06 lower (95% confidence interval: 0.3-1.8, P = 0.01). A median of two RBC units was transfused in the RBC transfusion arm. In the non-intervention arm, 33 women received RBC transfusion, mainly because of anaemic symptoms. Physical complications were comparable., Conclusions: Statistically, non-inferiority could not be demonstrated as the confidence interval crossed the non-inferiority boundary. Nevertheless, with only a small difference in physical fatigue and no differences in secondary outcomes, implementation of restrictive management seems clinically justified., (© 2014 Royal College of Obstetricians and Gynaecologists.)

Objective: To develop a patient decision aid (PtDA) for mode of delivery after caesarean section that integrates personalised prediction of vaginal birth after caesarean (VBAC) with the elicitation of patient preferences and evidence-based information., Design: A PtDA was developed and pilot tested using the International Patients Decision Aid Standards (IPDAS) criteria., Setting: Obstetric health care in the Netherlands., Population: A multidisciplinary steering group, an expert panel, and 25 future users of the PtDA, i.e. women with a previous caesarean section., Methods: The development consisted of a construction phase (definition of scope and purpose, and selection of content, framework, and format) and a pilot testing phase by interview. The process was supervised by a multidisciplinary steering group., Main Outcome Measures: Usability, clarity, and relevance., Results: The construction phase resulted in a booklet including unbiased balanced information on mode of birth after caesarean section, a preference elicitation exercise, and tailored risk information, including a prediction model for successful VBAC. During pilot testing, visualisation of risks and clarity formed the main basis for revisions. Pilot testing showed the availability of tailored structured information to be the main factor involving women in decision-making. The PtDA meets 39 out of 50 IPDAS criteria (78%): 23 out of 23 criteria for content (100%) and 16 out of 20 criteria for the development process (80%). Criteria for effectiveness (n = 7) were not evaluated., Conclusions: An evidence-based PtDA was developed, with the probability of successful VBAC and the availability of structured information as key items. It is likely that the PtDA enhances the quality of decision-making on mode of birth after caesarean section., (© 2013 Royal College of Obstetricians and Gynaecologists.)

Objective: To develop and internally validate a model that predicts the outcome of an intended vaginal birth after caesarean (VBAC) for a Western European population that can be used to personalise counselling for deliveries at term., Design: Registration-based retrospective cohort study., Setting: Five university teaching hospitals, seven non-university teaching hospitals, and five non-university non-teaching hospitals in the Netherlands., Population: A cohort of 515 women with a history of one caesarean section and a viable singleton pregnancy, without a contraindication for intended VBAC, who delivered at term., Methods: Potential predictors for a vaginal delivery after caesarean section were chosen based on literature and expert opinions. We internally validated the prediction model using bootstrapping techniques., Main Outcome Measures: Predictors for VBAC. For model validation, the area under the receiver operating characteristic curve (AUC) for discriminative capacity and calibration-per-risk-quantile for accuracy were calculated., Results: A total of 371 out of 515 women had a VBAC (72%). Variables included in the model were: estimated fetal weight greater than the 90(th) percentile in the third trimester; previous non-progressive labour; previous vaginal delivery; induction of labour; pre-pregnancy body mass index; and ethnicity. The AUC was 71% (95% confidence interval, 95% CI = 69-73%), indicating a good discriminative ability. The calibration plot shows that the predicted probabilities are well calibrated, especially from 65% up, which accounts for 77% of the total study population., Conclusion: We developed an appropriate Western European population-based prediction model that is aimed to personalise counselling for term deliveries., (© 2013 Royal College of Obstetricians and Gynaecologists.)

Objective: Review of the literature regarding the relation between the timing of epidural analgesia and the rate of caesarean or instrumental vaginal deliveries., Search Strategy: Pubmed, Embase and the Cochrane Library were searched for articles published until 31 July 2010., Selection Criteria: Studies were selected in which the effects of early latent phase (defined as a cervical dilatation of 3 cm or less) epidural analgesia (including combined-spinal epidural) and late active phase epidural analgesia on the mode of delivery in nulliparous women at 36 weeks of gestation or more were evaluated., Data Collection and Analysis: Data extraction was completed by using a data-extraction form. Risk ratio and its 95% confidence intervals were calculated for caesarean delivery and instrumental vaginal delivery. Pooled data were calculated., Main Results: The search retrieved 20 relevant articles, of which six fulfilled the selection criteria of inclusion. These six studies reported on 15,399 nulliparous women in spontaneous or induced labour with a request for analgesia. Risk of caesarean delivery (pooled risk ratio 1.02, 95% CI 0.96-1.08) or instrumental vaginal delivery (pooled risk ratio 0.96, 95% CI 0.89-1.05) was not significantly different between groups., Authors' Conclusions: This systematic review showed no increased risk of caesarean delivery or instrumental vaginal delivery for women receiving early epidural analgesia at cervical dilatation of 3 m or less in comparison with late epidural analgesia., (© 2011 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2011 RCOG.)

Objective: To assess the economic consequences of labour induction compared with expectant monitoring in women with gestational hypertension or pre-eclampsia at term., Design: An economic analysis alongside the Hypertension and Pre-eclampsia Intervention Trial At Term (HYPITAT)., Setting: Obstetric departments of six university and 32 teaching and district hospitals in the Netherlands., Population: Women diagnosed with gestational hypertension or pre-eclampsia between 36(+0) and 41(+0) weeks of gestation, randomly allocated to either induction of labour or expectant monitoring., Methods: A trial-based cost-effectiveness analysis was performed from a societal perspective during a 1-year time horizon., Main Outcome Measures: One-year costs were estimated and health outcomes were expressed as the prevalence of poor maternal outcome defined as either maternal complications or progression to severe disease., Results: The average costs of induction of labour (n = 377) were €7077 versus €7908 for expectant monitoring (n = 379), with an average difference of -€831 (95% CI -€1561 to -€144). This 11% difference predominantly originated from the antepartum period: per woman costs were €1259 for induction versus €2700 for expectant monitoring. During delivery, more costs were generated following induction (€2190) compared with expectant monitoring (€1210). No substantial differences were found in the postpartum, follow-up and for non-medical costs., Conclusion: In women with gestational hypertension or mild pre-eclampsia at term, induction of labour is less costly than expectant monitoring because of differences in resource use in the antepartum period. As the trial already demonstrated that induction of labour results in less progression to severe disease without resulting in a higher caesarean section rate, both clinical and economic consequences are in favour of induction of labour in these women., Trial Registration: The trial has been registered in the clinical trial register as ISRCTN08132825., (© 2010 The Authors Journal compilation © RCOG 2010 BJOG An International Journal of Obstetrics and Gynaecology.)

The effect of publication of the results of the Term Breech Trial in October 2000 on the mode of delivery of babies in breech presentation in the Netherlands was subject of this study. The results showed an immediate amplifying impact on top of the already existing trend of rising caesarean section rates for term singleton breech presentations. The willingness of obstetricians in the Netherlands to adopt the conclusions of the Term Breech Trial so quickly originate from scientific, legal, psychological and emotional sources. The same amplifying impact applied for all non-term breeches and breeches from multiple gestations, but not for babies in other than breech presentation.