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Contains fulltext : 205398.pdf (Publisher’s version ) (Open Access) INTRODUCTION: When women with a previous cesarean section and an unfavorable cervix have an indication for delivery, the choice is to induce labor or to perform a cesarean section. This study aims to assess the effectiveness and safety of a balloon catheter as a method of induction of labor in women with one previous cesarean section and an unfavorable cervix compared with an elective repeat cesarean section. MATERIAL AND METHODS: We performed a prospective cohort study in 51 hospitals in the Netherlands on term women with one previous cesarean section, a live singleton fetus in cephalic position, an unfavorable cervix and an indication for delivery. We recorded obstetric, maternal and neonatal characteristics. We compared the outcome of women who were induced with a balloon catheter with the outcome of women who delivered by elective repeat cesarean section. Main outcomes were maternal and neonatal morbidity. Mode of delivery was a secondary outcome for women who were induced. Adjusted odds ratios (aOR) were calculated using logistic regression, adjusted for potential confounders. RESULTS: Analysis was performed on 993 women who were induced and 321 women who had a repeat cesarean section (August 2011 until September 2012). Among the women who were induced, 560 (56.4%) delivered vaginally and 11 (1.1%) sustained a uterine rupture. Composite adverse maternal outcome (uterine rupture, severe postpartum hemorrhage or postpartum infection) occurred in 73 (7.4%) in the balloon and 14 (4.5%) women in the repeat cesarean section group (aOR 1.58, 95% confidence interval [CI] 0.85-2.96). Composite adverse neonatal outcome (Apgar score

Item does not contain fulltext 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.

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;119:11231130. 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.

Objective Pregnancies complicated by intrauterine growth retardation (IUGR) beyond 36 weeks of gestation are at increased risk of neonatal morbidity and mortality. Optimal treatment in IUGR at term is highly debated. Results from the multicenter DIGITAT (Disproportionate Intrauterine Growth Intervention Trial At Term) trial show that induction of labor and expectant monitoring result in equal neonatal and maternal outcomes for comparable cesarean section rates. We report the maternal health-related quality of life (HR-QoL) that was measured alongside the trial at several points in time. Methods Both randomized and non-randomized women were asked to participate in the HR-QoL study. Women were asked to fill out written validated questionnaires, covering background characteristics, condition-specific issues and the Short Form (SF-36), European Quality of Life (EuroQoL 6D3L), Hospital Anxiety and Depression scale (HADS), and Symptom Check List (SCL-90) at baseline, 6 weeks postpartum and 6 months postpartum. We compared the difference scores of all summary measures between the two management strategies by ANOVA. A repeated measures multivariate mixed model was defined to assess the effect of the management strategies on the physical (PCS) and mental (MCS) components of the SF-36. Analysis was by intention to treat. Results We analyzed data of 361 randomized and 198 non-randomized patients. There were no clinically relevant differences between the treatments at 6 weeks or 6 months postpartum on any summary measures; e.g., on the SF-36 (PCS: P = .09; MCS: P = .48). The PCS and the MCS were below norm values at inclusion. The PCS improved over time but stayed below norm values at 6 months, while the MCS did not improve. Conclusion In pregnancies complicated by IUGR beyond 36 weeks, induction of labor does not affect the long-term maternal quality of life.

Objective: In a recent randomized controlled trial we found that induction of labor in women with gestational hypertension (GH) or mild (preeclampsia) PE at term prevented high risk situations without increasing the cesarean section (CS) rate. We aimed to assess the predictability of the risk of CS.Study design: We used multivariable logistic regression analysis to identify predictive factors. Two models were created, one including antepartum and one including antepartum and intrapartum variables. The predictive capacity was assessed with ROC analysis and calibration.Results: 126(17%) of the 756 women delivered by CS. In multivariable analysis parity (OR 5.4), ethnicity (OR 2.4), previous miscarriage (OR 1.7), creatinine (OR 1.02), proteinuria (OR 2.4), cervical length (OR 1.02), engagement (OR 0.5) and dilatation (OR 0.7) were independent antepartum predictors. Intrapartum variables were parity (OR 3.6), ethnicity (OR 1.9), previous miscarriage (OR 1.5), gestational age at delivery (OR 1.2), antibiotic use (OR 8.0), disease progression (OR 2.4), uric acid (OR 1.4), proteinuria (OR 3.50) and dilatation (OR 0.76). Both models showed good discrimination (AUC 0.74 and 0.80) but calibration was moderate (Hosmer-Lemeshow P-value 0.42 and 0.70).Conclusion: In women with GH or mild PE at term, the risk of CS can be predicted. (C) 2015 Elsevier Ireland Ltd. All rights reserved.

Background Primary postpartum haemorrhage is an obstetrical emergency often causing acute anaemia that may require immediate red blood cell (RBC) transfusion. This anaemia results in symptoms such as fatigue, which may have major impact on the health-related quality of life. RBC transfusion is generally thought to alleviate these undesirable effects although it may cause transfusion reactions. Moreover, the postpartum haemoglobin level seems to influence fatigue only for a short period of time. At present, there are no strict transfusion criteria for this specific indication, resulting in a wide variation in postpartum policy of RBC transfusion in the Netherlands. Methods/Design The WOMB trial is a multicentre randomised non-inferiority trial. Women with acute anaemia due to postpartum haemorrhage, 12-24 hours after delivery and not initially treated with RBC transfusion, are eligible for randomisation. Patients with severe physical complaints are excluded. Patients are randomised for either RBC transfusion or expectant management. Health related quality of life (HRQoL) will be assessed at inclusion, at three days and one, three and six weeks postpartum with three validated measures (Multi-dimensional Fatigue Inventory, ShortForm-36, EuroQol-5D). Primary outcome of the study is physical fatigue three days postpartum. Secondary outcome measures are general and mental fatigue scores and generic health related quality of life scores, the number of RBC transfusions, length of hospital stay, complications and health-care costs. The primary analysis will be by intention-to-treat. The various longitudinal scores will be evaluated using Repeated Measurements ANOVA. A costs benefit analysis will also be performed. The power calculation is based on the exclusion of a difference in means of 1.3 points or greater in favour of RBC transfusion arm regarding physical fatigue subscale. With missing data not exceeding 20%, 250 patients per arm have to be randomised (one-sided alpha = 0.025, power = 80%). Discussion This study will provide evidence for a guideline regarding RBC transfusion in the postpartum patient suffering from acute anaemia. Equivalence in fatigue score, remaining HRQoL scores and physical complications between both groups is assumed, in which case an expectant management would be preferred to minimise transfusion reactions and costs. Trial registration ClinicalTrials.gov NCT00335023, Nederlands Trial Register NTR335

Contains fulltext : 65628.pdf ( ) (Open Access) BACKGROUND: Around 80% of intrauterine growth restricted (IUGR) infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term. METHODS/DESIGN: The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ). Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term). The study aims to include 325 patients per arm. DISCUSSION: This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term. TRIAL REGISTRATION: Dutch Trial Register and ISRCTN-Register: ISRCTN10363217.

Background Hypertensive disorders, i.e. pregnancy induced hypertension and preeclampsia, complicate 10 to15% of all pregnancies at term and are a major cause of maternal and perinatal morbidity and mortality. The only causal treatment is delivery. In case of preterm pregnancies conservative management is advocated if the risks for mother and child remain acceptable. In contrast, there is no consensus on how to manage mild hypertensive disease in pregnancies at term. Induction of labour might prevent maternal and neonatal complications at the expense of increased instrumental vaginal delivery rates and caesarean section rates. Methods/Design Women with a pregnancy complicated by pregnancy induced hypertension or mild preeclampsia at a gestational age between 36+0 and 41+0 weeks will be asked to participate in a multi-centre randomised controlled trial. Women will be randomised to either induction of labour or expectant management for spontaneous delivery. The primary outcome of this study is severe maternal morbidity, which can be complicated by maternal mortality in rare cases. Secondary outcome measures are neonatal mortality and morbidity, caesarean and vaginal instrumental delivery rates, maternal quality of life and costs. Analysis will be by intention to treat. In total, 720 pregnant women have to be randomised to show a reduction in severe maternal complications of hypertensive disease from 12 to 6%. Discussion This trial will provide evidence as to whether or not induction of labour in women with pregnancy induced hypertension or mild preeclampsia (nearly) at term is an effective treatment to prevent severe maternal complications. Trial Registration The protocol is registered in the clinical trial register number ISRCTN08132825.

for labor induction in women with gestational hypertension or mild preeclampsia at term: an exploratory analysis of the HYPITAT trial Parvin Tajik, Karin van der Tuuk, Corine Koopmans, Henk Groen, Marielle van Pampus, Paul van der Berg, Joris van der Post, Aren van Loon, Christianne de Groot, Anneke Kwee, Anjoke Huisjes, Erik van Beek, Dimitri N. M. Papatsonis, Kitty W.M. Bloemenkamp, Gijs van Unnik, Martina Porath, Robbert Rijnders, Rob Stigter, Karin de Boer, Liesbeth Scheepers, Patrick Bossuyt, Ben Mol Academic Medical Center, Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam, Netherlands, University Medical Center Groningen, Obstetrics and Gynaecology, Groningen, Netherlands, University Medical Center Groningen, Epidemiology, Groningen, Netherlands, University Medical Center Groningen, Obstetrics and Gynecology, Groningen, Netherlands, Academic Medical Center, Department of Obstetrics and Gynaecology, Amsterdam, Netherlands, Martini Hospital, Obstetrics and Gynaecology, Groningen, Netherlands, VU Medical Centre, Obstetrics and Gynaecology, Amsterdam, Netherlands, Dutch consortium AMPHIA trial, Netherlands, Gelre Hospital, Department of Obstetrics and Gynaecology, Apeldoorn, Netherlands, St Antonius Hospital, Obstetrics and Gynaecology, Nieuwegein, Netherlands, Amphia Hospital, Obstetrics and Gynaecology, Breda, Netherlands, Leiden University Medical Center, Department of Obstetrics and Gynecology, Leiden, Netherlands, Diaconessen Hospital, Obstetrics and Gynaecology, Leiden, Netherlands, Maxima Medical Center, Department of Obstetrics and Gynecology, Veldhoven, Netherlands, Jeroen Bosch Hospital, Department of Obstetrics and Gynaecology, Den Bosch, Netherlands, Deventer Hospital, Obstetrics and Gynaecology, Deventer, Netherlands, Rijnstate Hospital, Obstetrics and Gynaecology, Arnhem, Netherlands, University Medical Centre Nijmegen, Obstetrics and Gynaecology, Nijmegen, Netherlands OBJECTIVE: Examining whether cervical ripeness should defer obstetricians decision regarding labor induction for women with gestational hypertension or mild preeclampsia at term. STUDY DESIGN: We used the data from the HYPITAT trial (ISRCTN08132825), a multicenter, parallel, and open-label randomized controlled trial in women with a singleton pregnancy at term who had gestational hypertension or mild preeclampsia; in this trial 756 women had been randomized to either labor induction or expectant monitoring. We examined if the presence of an unfavorable cervix (measured by cervical length and Bishop score) would affect the superiority of labor induction compared to expectant monitoring. The primary outcome was the occurrence of a high risk maternal (HR) situation. Secondary outcomes were neonatal outcome and cesarean delivery. All analyses were by intention to treat and were done by using logistic regression. RESULTS: HR situations had occurred in 117 women (31%) in the labor induction group and in 166 women (44%) in the expectant monitoring group. The superiority of labor induction over expectant monitoring in preventing HR situations varied significantly according to cervical length (test for interaction p 0.03). In women with a long cervix ( 40 mm) or a low Bishop score (5). Similarly, the effect of induction on reducing the cesarean section rate was also stronger in women with a long cervix or a low bishop score. CONCLUSION: Against the widely held opinion that labor induction should be introduced when the cervix is ripe, women with gestational hypertension or mild preeclampsia, and with an unfavorable cervix benefit more from labor induction, as compared to expectant monitoring, than women with a ripe cervix. 793 Placental oxidative stress is an important mediator of IL-17 induced hypertension during pregnancy Pushpinder Dhillon, Jeremy Scott, Kedra Wallace, Judith Heath, Janae Moseley, James Martin, Babbette LaMarca University of Mississippi Medical Center, Obstetrics and Gynecology, Jackson, MS OBJECTIVE: New onset hypertension with proteinuria during pregnancy, preeclampsia is vastly becoming is associated with chronic immune activation. Recent studies show that preeclampsia is associated with activation of autoimmune cells, TH17, secreting interleukin-17, an inflammatory cytokine strongly associated with autoimmune diseases. Reactive oxygen species (ROS) is thought to be one important pathophysiological mediator of preeclampsia as well as many chronic immune disorders. The objective of our study was to determine if chronic exposure to IL-17 during pregnancy increases blood pressure by stimulating oxidative stress. STUDY DESIGN: To answer this question four groups of rats were examined: NP (n 20), NP IL-17 (n 7), NP tempol (n 7) (a superoxide dismutase mimetic that scavenges ROS) and NP IL17 Tempol (n 12). On day 14 of gestation miniosmotic pumps infusing IL-17 (150 pg/day) were implanted into NP rats while tempol was administered via the drinking water ad libitum. On day 18 of gestation carotid catheters were inserted and mean arterial pressure (MAP) was recorded, plasma, urine, and tissue were collected for isolation of ROS and detection by chemiluminescent technique. Urinary isoprostane was measured by ELISA. RESULTS: MAP increased from 98 / 3 in NP to 123 / 3 mmHg in IL17 infused NP rats. Urinary isoprostane increased with chronic IL-17 from 1029 / 1 pg/mg/day in NP rats to 3526 / 2 pg/mg/ day in IL-17 infused, p 0.05. Placental ROS was 436 / 4 RLU/ml/ min (n 4) in NP to 702 / 5 (n 5) RLU/ml/min in IL-17 treated rats. Administration of Tempol attenuated the blood pressure increase to IL-17. MAP was 102 / 5 mmHg in Tempol controls and was unchanged in NP IL-17 tempol, 101 / 3 mmHg. Tempol attenuated placental ROS production to 459 / 5 (n 5) RLU/ml/ min in IL17 Tempol, which was no different from Tempol controls, 474 / 5 (n 3) RLU/ml/min CONCLUSION: These data indicate that chronic IL-17 causes placental oxidative stress, which plays an important role in mediating IL-17 induced hypertension during pregnancy.