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Please cite this paper as: Tajik P, van der Tuuk K, Koopmans C, Groen H, van Pampus M, van der Berg P, van der Post J, van Loon A, de Groot C, Kwee A, Huisjes A, van Beek E, Papatsonis D, Bloemenkamp K, van Unnik G, Porath M, Rijnders R, Stigter R, de Boer K, Scheepers H, Zwinderman A, Bossuyt P, Mol B. Should cervical favourability play a role in the decision for labour induction in gestational hypertension or mild pre-eclampsia at term? An exploratory analysis of the HYPITAT trial. BJOG 2012;119:1123-1130. Objective To examine whether cervical favourability (measured by cervical length and the Bishop score) should inform obstetricians' decision regarding labour induction for women with gestational hypertension or mild pre-eclampsia at term. Design A post hoc analysis of 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 A total of 756 women diagnosed with gestational hypertension or pre-eclampsia between 36 + 0 and 41 + 0 weeks of gestation randomly allocated to induction of labour or expectant management. Methods Data were analysed using logistic regression modelling. Main outcome measures The occurrence of a high-risk maternal situation defined as either maternal complications or progression to severe disease. Secondary outcomes were caesarean delivery and adverse neonatal outcomes. Results The superiority of labour induction in preventing high-risk situations in women with gestational hypertension or mild pre-eclampsia at term varied significantly according to cervical favourability. In women who were managed expectantly, the longer the cervix the higher the risk of developing maternal high-risk situations, whereas in women in whom labour was induced, cervical length was not associated with a higher probability of maternal high-risk situations (test of interaction P = 0.03). Similarly, the beneficial effect of labour induction on reducing the caesarean section rate was stronger in women with an unfavourable cervix. Conclusion Against widely held opinion, our exploratory analysis showed that women with gestational hypertension or mild pre-eclampsia at term who have an unfavourable cervix benefited more from labour induction than other women. Trial registration The trial has been registered in the clinical trial register as ISRCTN08132825. [ABSTRACT FROM AUTHOR]

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 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., (© 2013 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2013 RCOG.)

Objective: To investigate the association between maternal intrapartum fever and ST-waveform changes of the fetal electrocardiogram., Design: Retrospective cohort study., Setting: Three academic and six non-academic teaching hospitals in the Netherlands., Population: Labouring women with a high-risk singleton pregnancy in cephalic position beyond 36 weeks of gestation., Methods: We studied 142 women with fever (≥38.0°C) during labour and 141 women with normal temperature who had been included in two previous studies. In both groups, we counted the number and type of ST-events and classified them as significant (intervention needed) or not significant, based on STAN(®) clinical guidelines., Main Outcome Measures: Number and type of ST-events., Results: Both univariable and multivariable regression analysis showed no association between the presence of maternal intrapartum fever and the number or type of ST-events., Conclusions: Maternal intrapartum fever is not associated with ST-segment changes of the fetal electrocardiogram. Interpretation of ST-changes in labouring women with fever should therefore not differ from other situations., (© 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.)

Objective: To examine whether cervical favourability (measured by cervical length and the Bishop score) should inform obstetricians' decision regarding labour induction for women with gestational hypertension or mild pre-eclampsia at term., Design: A post hoc analysis of 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: A total of 756 women diagnosed with gestational hypertension or pre-eclampsia between 36 + 0 and 41 + 0 weeks of gestation randomly allocated to induction of labour or expectant management., Methods: Data were analysed using logistic regression modelling., Main Outcome Measures: The occurrence of a high-risk maternal situation defined as either maternal complications or progression to severe disease. Secondary outcomes were caesarean delivery and adverse neonatal outcomes., Results: The superiority of labour induction in preventing high-risk situations in women with gestational hypertension or mild pre-eclampsia at term varied significantly according to cervical favourability. In women who were managed expectantly, the longer the cervix the higher the risk of developing maternal high-risk situations, whereas in women in whom labour was induced, cervical length was not associated with a higher probability of maternal high-risk situations (test of interaction P = 0.03). Similarly, the beneficial effect of labour induction on reducing the caesarean section rate was stronger in women with an unfavourable cervix., Conclusion: Against widely held opinion, our exploratory analysis showed that women with gestational hypertension or mild pre-eclampsia at term who have an unfavourable cervix benefited more from labour induction than other women., Trial Registration: The trial has been registered in the clinical trial register as ISRCTN08132825., (© 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.)

Objective: To evaluate whether progression to a high-risk situation is predictable in women with gestational hypertension (GH) or mild pre-eclampsia (PE) at term., Methods: Women with a singleton pregnancy, a fetus in cephalic position, between 36 and 41 weeks of gestation, complicated by GH or mild PE that were managed expectantly, were selected from the HYPITAT trial. We evaluated the predictability of progression to a high-risk situation. Logistic regression was used to determine the predictive value of clinical characteristics or laboratory findings and to generate a prediction model for progression to a high-risk situation. The predictive value of this model was assessed with receiver-operating characteristic (ROC) analysis, calibration and internal validation., Results: We included 703 women, of whom 244 (34.7%) had progression to a high-risk situation. After multivariable analysis, nulliparity (OR 1.87), maternal age (OR 1.05 per year), gestational age (OR 0.88 per week), previous abortion (OR 1.26), ethnicity (OR 2.05 for non-Caucasian ethnicity), diastolic (OR 1.04 per mmHg), systolic blood pressure (OR 1.02 per mmHg) and the laboratory parameters proteinuria, haemoglobin, platelets, uric acid and alanine aminotransferase were included in the final model. The area under the ROC curve of this model was 0.71 (95% CI, 0.67-0.74). Even though the goodness of fit was moderate (P=0.40), internal validation showed the model could hold in the overall population., Conclusion: In the prediction of progression to a high-risk situation, in women with GH or mild PE at term, a distinction can be made between women with a low risk and women with high risk., (© 2011 The Authors. Australian and New Zealand Journal of Obstetrics and Gynaecology © 2011 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.)

Background: In current literature, no data on safety in pregnancy for new drugs in the treatment of multiple sclerosis (MS) like natalizumab (Tysabri®), a humanized monoclonal antibody against α4 integrins, are yet available. In the management of MS, natalizumab is the first monoclonal antibody approved to the market., Methods: We describe the pregnancy and outcome in two women with MS using natalizumab. The first patient used it in the periconceptional period, and the second patient used it in both the periconceptional period and throughout gestation., Results: The antenatal course of the first patient was complicated by an exacerbation of MS. The second patient did not experience MS relapses during pregnancy, while still using natalizumab. The newborns did not show any abnormalities postnatal and at 6 weeks' follow-up., Conclusions: This is the first detailed report on pregnancy and delivery of two babies after maternal treatment of MS with natalizumab. From the small number of cases on the usage of natalizumab during pregnancy in literature, we cannot conclude whether the use of natalizumab is safe, and long-term effects are not known. Further research is needed to establish the exact effects on pregnancy and intrauterine development as well as the long-term effects. Prenatal counseling with thorough explanation of the risks and careful decision making is advisable., (© 2010 John Wiley & Sons A/S.)