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Objective To propose a staging system for congenital lower urinary tract obstruction (LUTO) capable of predicting the severity of the condition and its prognosis.Methods This was a national retrospective study carried out at the eight Academic Hospitals in The Netherlands. We collected prenatal and postnatal data of fetuses at high risk of isolated LUTO that were managed conservatively. Postnatal renal function was assessed by the estimated glomerular filtration rate (eGFR), calculated using the Schwartz formula, considering the length of the infant and the creatinine nadir in the first year after birth. Receiver-operating characteristics (ROC) curve analysis, univariate analysis and multivariate logistic regression analysis with stepwise backward elimination were performed in order to identify the best antenatal predictors of perinatal mortality and postnatal renal function.Results In total, 261 fetuses suspected of having LUTO and managed conservatively were included in the study. The pregnancy was terminated in 110 cases and perinatal death occurred in 35 cases. Gestational age at appearance of oligohydramnios showed excellent accuracy in predicting the risk of perinatal mortality with an area under the ROC curve of 0.95 (P Conclusions Gestational age at appearance of oligo-or anhydramnios and BV at diagnosis can accurately predict mortality and morbidity in fetuses with LUTO. Our proposed staging system can triage reliably fetuses with LUTO and predict the severity of the condition and its prognosis. Copyright (c) 2018 ISUOG. Published by John Wiley & Sons Ltd.

The aim of this study was to test whether women who conceived after a period of subfertility are less likely to undergo invasive prenatal testing (IPT) and determine factors of influence in that decision. We conducted a retrospective study at the Maastricht University Medical Centre (MUMC+) to compare the rates of IPT following abnormal results of combined first trimester screening (cFTS) or second trimester screening (STS), or because of advanced maternal age among women tested for the effect of type and duration of subfertility and history of fertility investigations and/or treatment. We included 977 women who underwent IPT between January 2010 and December 2013. The women who conceived after fertility investigations and/or treatment had lower rates of IPT following abnormal STS (12.6% vs. 20.0%, OR = 0.58, 95% CI; 0.34-0.97). The difference was not statistically significant after correction for maternal age and severity of the foetal anomaly. Maternal age was, in contrast to fertility treatment or duration of subfertility, related to the choice of IPT among formerly subfertile women. Therefore, the lower uptake of IPT in women conceiving after a period of subfertility is dependent on the indication for IPT and maternal age and less on the type and duration of subfertility.

OBJECTIVE: To compare the effects of immediate delivery an expectant management among women whose pregnancies were complicated by preterm prelabor rupture of membranes (PROM) in the late preterm period (from 34 0/7 weeks until 36 6/7 weeks of gestation). DATA SOURCES: PubMed, Scopus, ClinicalTrials.gov, EMBASE, and the Cochrane Central Register of Controlled Trials were searched from inception until December 2016. METHODS OF STUDY SELECTION: We included all randomized controlled trials with individual participant data reporting on late preterm PROM with randomization to immediate delivery or expectant management. The primary outcome was a composite of adverse neonatal outcomes: probable or definitive neonatal sepsis, necrotizing enterocolitis, respiratory distress syndrome, stillbirth, or neonatal death. TABULATION, INTEGRATION AND RESULTS: Of eight eligible trials (total n=3,203 mothers), three (2,563 mothers, 2,572 neonates) had individual participant data available. The composite adverse neonatal outcome occurred in 9.6% of neonates in the immediate delivery group and 8.3% in the expectant management group (relative risk [RR] 1.20, 95% CI 0.94-1.55). Neonatal sepsis rates were 2.6% and 3.5%, respectively (RR 0.74, 95% CI 0.47-1.15). Neonates in the immediate delivery group were more likely to be diagnosed with respiratory distress syndrome (RR 1.47, 95% CI 1.10-1.97), and to be admitted to the neonatal intensive care unit or special care nursery (RR 1.17, 95% CI 1.11-1.23) and had longer admissions. Mothers randomized to immediate delivery were less likely to have an antepartum hemorrhage (RR 0.57, 95% CI 0.34-0.95) or chorioamnionitis (RR 0.21, 95% CI 0.13-0.35), but more likely to undergo cesarean delivery (RR 1.26, 95% CI 1.08-1.47). CONCLUSION: In women with late preterm PROM, immediate delivery and expectant management resulted in comparable rates of the composite of adverse neonatal outcomes. Effects on individual secondary maternal and neonatal outcomes were mixed. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, 42016032972.

Objectives: To investigate the natural history of fetal megacystis from diagnosis in utero to postnatal outcome, and to identify prognostic indicators of spontaneous resolution and postnatal outcome after resolution. Methods: This was a national retrospective cohort study. Fetal megacystis was defined in the first trimester as a longitudinal bladder diameter (LBD) ≥ 7 mm, and in the second and third trimesters as an enlarged bladder failing to empty during the entire extended ultrasound examination. LBD and gestational age (GA) at resolution were investigated with respect to likelihood of resolution and postnatal outcome, respectively. Sensitivity, specificity and area under the receiver–operating characteristics curve (AUC) were calculated. Results: In total, 284 cases of fetal megacystis (93 early megacystis, identified before the 18th week, and 191 late megacystis, identified at or after the 18th week) were available for analysis. Spontaneous resolution occurred before birth in 58 (20%) cases. In cases with early megacystis, LBD was predictive of the likelihood of spontaneous resolution (sensitivity, 80%; specificity, 79%; AUC, 0.84), and, in the whole population, GA at regression was predictive of postnatal outcome, with an optimal cut-off at 23 weeks (sensitivity, 100%; specificity, 82%; AUC, 0.91). In the group with early megacystis, the outcome was invariably good when resolution occurred before the 23rd week of gestation, whereas urological sequelae requiring postnatal surgery were diagnosed in 3/8 (38%) cases with resolution after 23 weeks. In the group with late megacystis, spontaneous resolution was associated with urological complications after birth, ranging from mild postnatal hydronephrosis in infants with resolution before 23 weeks, to more severe urological anomalies requiring postnatal surgery in those with resolution later in pregnancy. This supports the hypothesis that an early resolution of megacystis is often related to a paraphysiological bladder enlargement that resolves early in pregnancy without consequences, while antenatal resolution occurring later in pregnancy (after the 23rd week of gestation) should suggest a pathological condition with urological sequelae. Conclusions: In fetal megacystis, LBD and GA at regression can be used as predictors of resolution and outcome, respectively. These parameters could help in fine-tuning the prognosis and optimizing the frequency of follow-up scans.

Objective: To establish a threshold value for fetal renal pelvis dilatation measured by automatic volume calculation (SonoAVC) in the third trimester of pregnancy to predict neonatal uropathies, and to compare these results with conventional antero-posterior (AP) measurement, fetal kidney 3D volume and renal parenchymal thickness.Methods: In a prospective cohort study, 125 fetuses with renal pelvis AP diameter of 5mm both at 20 weeks of gestation and in the third trimester, underwent an additional 3D volume measurement of the fetal kidney in the third trimester. Receiver operating characteristic (ROC) curves for establishing threshold values for fetal renal pelvis volume, AP measurement, fetal kidney volume and renal parenchymal thickness to predict neonatal uropathies were analyzed. Also, sensitivity, specificity, area under the curve (AUC) and likelihood ratios were calculated.Results: A cut-off point of 1.58cm(3) was identified in the third trimester of pregnancy (AUC 0.865 (95% CI 0.789-0.940), sensitivity 76.3%, specificity 87.4%, LR+6.06, LR-0.27) for measurements with SonoAVC. A cut-off value of 11.5mm was established in the third trimester of pregnancy (AUC 0.828 (95% CI 0.737-0.918), sensitivity 71.1%, specificity 85.1%, LR+4.77, LR-0.34) for the conventional AP measurement. A cut-off point for fetal kidney volume was calculated at 13.29cm(3) (AUC 0.769 (95% CI 0.657-0.881), sensitivity 71%, specificity 66%, LR+2.09, LR-0.44). For renal parenchymal thickness, a cut-off point of 8.4mm was established (AUC 0.216 (95% CI 0.117-0.315), sensitivity 31.6%, specificity 32.6%, LR+0.47, LR-2.10).Conclusion: This study demonstrates that 3D fetal renal pelvis volume measurements and AP measurements both have a good and comparable diagnostic performance, fetal renal volume a fair accuracy and renal parenchymal thickness a poor accuracy in predicting postnatal renal outcome.

Objective: To investigate the best criteria for discriminating fetuses with isolated posterior urethral valves from those theoretically not eligible for fetal treatment because of complex megacystis, high chance of spontaneous resolution, and urethral atresia. Methods: A retrospective national study was conducted in fetuses with megacystis detected before 17 weeks’ gestation (early megacystis). Results: In total, 142 cases with fetal megacystis were included in the study: 52 with lower urinary tract obstruction, 29 with normal micturition at birth, and 61 with miscellaneous syndromal associations, chromosomal and multiple structural abnormalities (complex megacystis). Only a nuchal translucency > 95th centile, and not a longitudinal bladder diameter ≤15 mm (p = 0.24), significantly increased the risk of complex megacystis (p < 0.01). Cases with a high chance of spontaneous resolution were identified by using the cut-off of 12 mm, as demonstrated in a previous study, and the finding of an associated umbilical cord cyst carried a high-risk of urethral atresia (odds ratio: 15; p = 0.026), an unfavorable condition for antenatal treatment. An algorithm encompassing these three criteria demonstrated good accuracy in selecting fetuses theoretically eligible for fetal treatment (specificity 73%; sensitivity 92%). Conclusions: Cases theoretically eligible for early fetal therapy are those with normal nuchal translucency, a longitudinal bladder diameter > 12 mm, and without ultrasound evidence of umbilical cord cysts.

Objective: To propose a clinical score for the optimal antenatal diagnosis of fetal lower urinary tract obstruction (LUTO) in the second and third trimesters of pregnancy, as an alternative to the commonly used ultrasound triad of megacystis, keyhole sign and hydronephrosis. Methods: This was a national retrospective study carried out at the eight tertiary fetal medicine units (FMUs) in The Netherlands. Only cases referred for megacystis from the second trimester onwards and with a clear postnatal diagnosis were included in the study. At referral, data were collected on amniotic fluid volume, renal cortical appearance, bladder volume, hydronephrosis, fetal ascites, ureteral size, keyhole sign, fetal sex and gestational age. Multivariate analysis was performed, starting by including all antenatal variables, and then excluding the weakest predictors using the backward stepwise strategy. Results: Over a 7-year period, 312 fetuses with a diagnosis of megacystis were referred to the eight Dutch tertiary FMUs. A final diagnosis was achieved in 143 cases, including 124 of LUTO and 19 reclassified after birth as non-obstructive megacystis. The optimal bladder volume cut-off for prediction of LUTO was 35 cm3 (area under the curve (AUC) = 0.7, P = 0.03). The clinical score formulated on the basis of the multivariate analysis included fetal sex, degree of bladder distension, ureteral size, oligo- or anhydramnios and gestational age at referral. The combination of these five variables demonstrated good accuracy in discriminating LUTO from non-obstructive megacystis (AUC = 0.84, P < 0.001), compared with the poor performance of the ultrasound triad (AUC = 0.63, P = 0.07). Conclusions: We propose a clinical score that combines five antenatal variables for the prospective diagnosis of congenital LUTO. This score showed good discriminative capacity in predicting LUTO, and better diagnostic accuracy compared with that of the classic ultrasound triad. Future studies to validate these results should be carried out in order to refine antenatal management of LUTO and prevent inappropriate fetal interventions. © 2017 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of the International Society of Ultrasound in Obstetrics and Gynecology.

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.

Contains fulltext : 168757.pdf (Publisher’s version ) (Closed access) OBJECTIVE: To determine outcome of children born with isolated gastroschisis (no extra-gastrointestinal congenital abnormalities). STUDY DESIGN: International cohort study and meta-analysis. PRIMARY OUTCOME: time to full enteral feeding (TFEF); secondary outcomes: Duration of mechanical ventilation, length of stay (LOS), mortality and differences in outcome between simple and complex gastroschisis (complex; born with bowel atresia, volvulus, perforation or necrosis). To compare the cohort study results with literature three databases were searched. Studies were eligible for inclusion if cases were born in developed countries with isolated gastroschisis after 1990, number of cases >20 and TFEF was reported. RESULTS: The cohort study included 204 liveborn cases of isolated gastroschisis. The TFEF, median duration of ventilation and LOS was, 26days (range 6-515), 2days (range 0-90) and 33days (range 11-515), respectively. Overall mortality was 10.8%. TFEF and LOS were significantly longer (P

Please cite this paper as: Becker J, van Rijswijk J, Versteijnen B, Evers A, van den Akker E, van Beek E, Bolte A, Rijnders R, Mol B, Moons K, Porath M, Drogtrop A, Schuitemaker N, Willekes C, Westerhuis M, Visser G, Kwee A. Is intrapartum fever associated with ST-waveform changes of the fetal electrocardiogram? A retrospective cohort study. BJOG 2012;119:1410–1416. 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.

Objective. To evaluate whether correct adherence to clinical guidelines might have led to prevention of cases with adverse neonatal outcome. Design. Secondary analysis of cases with adverse outcome in a multicenter randomized clinical trial. Setting. Nine Dutch hospitals. Population. Pregnant women with a term singleton fetus in cephalic position. Methods. Data were obtained from a randomized trial that compared monitoring by STAN (R) (index group) with cardiotocography (control group). In both trial arms, three observers independently assessed the fetal surveillance results in all cases with adverse neonatal outcome, to determine whether an indication for intervention was present, based on current clinical guidelines. Main outcome measures. Adverse neonatal outcome cases fulfilled one or more of the following criteria: (i) metabolic acidosis in umbilical cord artery (pH 12 mmol/L); (ii) umbilical cord artery pH

In women who have suffered mid-trimester prelabor rupture of membranes (PPROM), prediction of pulmonary hypoplasia is important for optimal management. We performed a systematic review to assess the capacity of imaging parameters to predict pulmonary hypoplasia. We searched for published articles that reported on biometric parameters and allowed the construction of a 2 X 2 table, comparing at least one of these parameters with the occurrence of pulmonary hypoplasia. The selected studies were scored on methodological quality and we calculated sensitivity and specificity of the tests in the prediction of pulmonary hypoplasia and lethal pulmonary hypoplasia. Overall performance was assessed by summary receiveroperating characteristics (sROC) analyses that were performed with bivariate meta-analysis. We detected 13 studies that reported on the prediction of lethal pulmonary hypoplasia. The quality of the included studies was poor to mediocre. The estimated sROC curves for the chest circumference/abdominal circumference ratio and other parameters showed limited accuracy in the prediction of pulmonary hypoplasia. In women with mid-trimester PPROM, the available evidence indicates limited accuracy of biometric parameters in the prediction of pulmonary hypoplasia. Copyright (c) 2012 ISUOG. Published by John Wiley & Sons, Ltd

Objective. To evaluate the added value of the baseline T/QRS ratio to other known risk factors in predicting adverse outcome and interventions for suspected fetal distress. Design. Prospective cohort study. Setting. Three academic and six non-academic teaching hospitals in the Netherlands. Population. Laboring women with a high-risk cephalic singleton pregnancy beyond 36 weeks of gestation. Methods. We obtained STAN® recordings (ST-analysis, Neoventa, Sweden) from two previous studies. Three patient groups were defined: cases with adverse outcome, cases with emergency delivery because of suspected fetal distress without adverse outcome, and a reference group of uncomplicated cases. Baseline T/QRS ratios among the adverse outcome and intervention for suspected fetal distress cases were compared to those of the uncomplicated cases. The ability of baseline T/QRS to predict adverse outcome and suspected fetal distress was determined using a multivariable logistic model. Main outcome measures. The added value of the baseline T/QRS to other known risk factors in the prediction of adverse outcome and interventions for suspected fetal distress. Results. From 3462 recordings, 2459 were available for analysis. Median baseline T/QRS for uncomplicated cases, adverse outcome and interventions for suspected fetal distress were 0.12 (range 0.00–0.52), 0.12 (0.00–0.42) and 0.13 (0.00–0.39), respectively. There was no statistical difference between these groups. Multivariable analysis showed no added value of baseline T/QRS in the prediction of either adverse outcome or interventions for suspected fetal distress. Conclusion. Baseline T/QRS has no added value in the prediction of adverse neonatal outcome or interventions for suspected fetal distress.

Item does not contain fulltext OBJECTIVE: The aim of this study is to assess the correlation of the average antero-posterior, transverse and longitudinal diameters of the fetal renal pelvis to neonatal outcome. METHODS: This retrospective study evaluates the neonatal outcome of all fetuses with suspected pyelectasis on ultrasonographic examination between May 1997 and March 2006. During this time, 764 fetuses with pyelectasis and 1285 renal units were scanned. We defined fetal pyelectasis as mild if the ARP was >/= 5-/= 10-/= 15 mm. A total of 612 fetuses met the inclusion criteria. The Corteville criteria in the third trimester (antero-posterior diameter >/= 7 mm) and an antero-posterior diameter (AP) of >/= 10 mm were compared with the ARP and likelihood ratio's calculated. Ultrasonographic evaluation took place in the third trimester if fetal pyelectasis was diagnosed as an isolated finding in the second trimester. This last ultrasonographic examination was used for final analysis and as a guideline for postnatal follow-up. Neonatal outcome was assessed by reviewing medical records, ultrasonographic, renographic and voiding cysto-urethrographic results. RESULTS: Of all the fetuses diagnosed with renal pelvis dilatation in the third trimester of pregnancy, 73 (11.9%) infants needed postnatal surgery. The majority of the postnatal surgery was performed in the group of fetuses with severe hydronephrosis (8.2%). This resulted in a LR of 5.81 and a post-test probability of 61.3%. In total, 78.8% of the fetuses with hydronephrosis had spontaneous resolution across all grades of severity on the first postnatal ultrasonogaphic investigation or during their follow-up. In 9.3% of the cases, uropathies were diagnosed, but no surgical intervention had taken place during the follow-up period. Using the Corteville criteria as gold standard for the third trimester (AP >/= 7 mm), 11 (1.8%) patients would not have been diagnosed with uropathies. And in the case of AP >/= 10 mm, 5.1% of the cases would have been missed. CONCLUSION: An ARP of >/= 5 mm in the second and/or third trimester of pregnancy enables a better detection of patients with uropathies and indication for surgery as compared with AP >/= 10 mm, but renders almost similar results compared with the Cortville criteria (AP >/= 7 mm) in the third trimester. 01 juli 2012

Congenital hydrocephalus is a common and often disabling disorder. The etiology is very heterogeneous. Little is known about the genetic causes of congenital hydrocephalus.A retrospective survey was performed including patients with primary congenital hydrocephalus referred to the Department of Clinical Genetics between 1985 and 2010 by perinatologists, (child) neurologists or pediatricians. Patients with hydrocephalus secondary to other pathology were excluded from this survey. We classified patients with primary congenital hydrocephalus into two main groups: non-syndromic hydrocephalus (NSH) and syndromic hydrocephalus (SH). Seventy-five individuals met the inclusion criteria, comprising 36% (27/75) NSH and 64% (48/75) SH. In 11% (8/75) hydrocephalus was familial. The cause of hydrocephalus was unknown in 81% (61/75), including all patients with NSH. The male-female ratio in this subgroup was 2.6:1, indicating an X-linked factor other than the L1CAM gene. In the group of SH patients, 29% (14/48) had a known cause of hydrocephalus including chromosomal abnormalities, L1 syndrome, Marden-Walker syndrome, Walker-Warburg syndrome and hemifacial microsomia.We performed this survey in order to evaluate current knowledge on the genetic etiology of primary congenital hydrocephalus and to identify new candidate genes or regulatory pathways for congenital hydrocephalus. Recommendations were made concerning the evaluation and genetic workup of patients with primary congenital hydrocephalus. We conclude that further molecular and functional analysis is needed to identify new genetic forms of congenital hydrocephalus. (C) 2011 Elsevier Masson SAS. All rights reserved.

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.

OBJECTIVE: To study perinatal mortality rates in a cohort of 465 monochorionic (MC) twins without twin-twin transfusion syndrome (TTS) born at 32 weeks of gestation or later since reported interauterine fetal death (IUFD) rates >32 weeks of gestations in the literature vary, leading to varying recommendations on the optimal timing of delivery, and to investigate the relation between perinatal mortality and mode of delivery. DESIGN: Multicentre retrospective cohort study. SETTING: Ten perinatal referral centres in the Netherlands. POPULATION: All MC twin pregnancies without TTTS delivered at >/= 32 weeks of gestation between January 2000 and December 2005. METHODS: The medical records of all MC twin pregnancies without TTTS delivered at the ten perinatal referral centres in the Netherlands between January 2000 and December 2005 were reviewed. MAIN OUTCOME MEASURES: Perinatal mortality in relation to gestational age and mode of delivery at >/= 32 weeks of gestation. RESULTS: After 32 weeks of gestation, five out of 930 fetuses died in utero and there were six neonatal deaths (6 per 1000 infants). In women who delivered >/= 37 weeks, perinatal mortality was 7 per 1000 infants. Trial of labour was attempted in 376 women and was successful in 77%. There were three deaths in deliveries with a trial of labour (8 per 1000 deliveries), of which two were related to mode of delivery. Infants born by caesarean section without labour had an increased risk of neonatal morbidity and respiratory distress syndrome. CONCLUSIONS: In MC twin pregnancies the incidence of intrauterine fetal death is low >/= 32 weeks of gestation. Therefore, planned preterm delivery before 36 weeks does not seem to be justified. The risk of intrapartum death is also low, at least in tertiary centres.

Prediction of pulmonary hypoplasia after midtrimester preterm prelabour rupture of membranes (PPROM) is important for optimal management. We performed a systematic review to assess the capacity of clinical parameters to predict pulmonary hypoplasia. A systematic literature search in EMBASE and MEDLINE was performed to identify articles published on pulmonary hypoplasia in relation to midtrimester PPROM. Articles were selected when they reported on one of the following clinical parameters - gestational age at PPROM, latency period and degree of oligohydramnios - and when they allowed the construction of a two-by-two table comparing at least one of three clinical parameters to the occurrence of pulmonary hypoplasia. The selected studies were scored on methodological quality, and sensitivity and specificity of the tests in the prediction of pulmonary hypoplasia and lethal pulmonary hypoplasia were calculated. Overall performance was assessed by summary receiver operating characteristic (sROC) curves that were constructed with bivariate meta-analysis. We detected 28 studies that reported on the prediction of pulmonary hypoplasia. Prediction of lethal pulmonary hypoplasia could be analysed separately in 21 of these studies. The quality of the included studies was poor. The estimated sROC-curves showed that gestational age at PPROM performed significantly better than the two other parameters in the prediction of pulmonary hypoplasia. The accuracy in the prediction of lethal pulmonary hypoplasia was similar. In women with midtrimester PPROM, pulmonary hypoplasia can be predicted from the gestational age at PPROM. This information should be used in the management of women with early PROM. (C) 2009 Elsevier Ireland Ltd. All rights reserved

Background Robust evidence to direct management of pregnant women with mild hypertensive disease at term is scarce. We investigated whether induction of labour in women with a singleton pregnancy complicated by gestational hypertension or mild pre-eclampsia reduces severe maternal morbidity. Methods We undertook a multicentre, parallel, open-label randomised controlled trial in six academic and 32 non-academic hospitals in the Netherlands between October, 2005, and March, 2008. We enrolled patients with a singleton pregnancy at 36-41 weeks gestation, and who had gestational hypertension or mild pre-eclampsia. Participants were randomly allocated in a 1:1 ratio by block randomisation. with a web-based application system to receive either induction of labour or expectant monitoring. Masking of intervention allocation was not possible. The primary outcome was a composite measure of poor maternal outcome-maternal mortality, maternal morbidity (eclampsia, HELLP syndrome, pulmonary oedema, thromboembolic disease, and placental abruption), progression to severe hypertension or proteinuria, and major post-partum haemorrhage (>1000 ml, blood loss). Analysis was by intention to treat and treatment effect is presented as relative risk. This study is registered, number ISRCTN08132825. Findings 756 patients were allocated to receive induction of labour (n=377 patients) or expectant monitoring (n=379). 397 patients refused randomisation but authorised use of their medical records. Of women who were randomised, 117 (31%) allocated to induction of labour developed poor maternal outcome compared with 166 (44%) allocated to expectant monitoring (relative risk 0.71, 95% CI 0.59-0.86, p

Contains fulltext : 81916.pdf (Publisher’s version ) (Closed access) OBJECTIVE: To study perinatal mortality and neonatal morbidity in a large cohort of monoamniotic twin pregnancies with special emphasis to the gestational age-specific mortality. METHODS: The study included monoamniotic twin pregnancies delivered in 10 perinatal centers in the Netherlands between January 2000 and December 2007. RESULTS: A total of 98 monoamniotic pregnancies were included. The perinatal mortality rate (20 weeks of gestation through 28 days of life) was 19%; after exclusion of fetuses with lethal anomalies, the rate was 17%. After 32 weeks of gestation, only two pregnancies were complicated by perinatal mortality (4%). The incidence of twin-twin transfusion syndrome was 6%. The incidence of congenital heart anomalies and cerebral injury was 4% and 5%, respectively. CONCLUSION: The current incidence of perinatal mortality in monoamniotic twins is considerably lower than in previous decades, but it is still high and occurs throughout pregnancy. LEVEL OF EVIDENCE: III.

Preterm premature rupture of the fetal membranes (PPROM) is associated with intra-uterine infection. Early detection of intra-uterine infection may help prevent neonatal sepsis. C-reactive protein (CRP) is an acute phase protein often elevated when inflammation is present. The aim of this review was to assess whether CRP accurately predicts chorioamnionitis and/or neonatal sepsis in women with PPROM. We searched Medline and Embase databases for articles reporting on CRP and chorioamnionitis and/or neonatal sepsis. Two reviewers extracted clinical and methodological study characteristics and test accuracy data. Accurate data were used to form 2 x 2 data tables comparing CRP and the occurrence of infection. For the selected studies, sensitivity and specificity of CRP in the prediction of histological chorioamnionitis, clinical chorioamnionitis and neonatal sepsis were calculated separately. A bivariate meta-regression model was used to calculate pooled estimates of sensitivity and specificity. The search revealed 200 articles, of which only five met the inclusion criteria. These five articles reported on 381 patients, of which four articles (227 patients) reported on CRP as a predictor for histological chorioamnionitis and four studies (330 patients) reported on CRP as a predictor for clinical chorioamnionitis. None of the selected articles fulfilled our criteria for the use of CRP as a predictor of neonatal sepsis. CRP was moderately predictive of histological chorioamnionitis. Unfortunately, the studies of clinical chorioamnionitis were too heterogeneous to pool data. Current literature does not support the use of CRP in women with PPROM. (C) 2009 Elsevier Ireland Ltd. All rights reserved

Item does not contain fulltext INTRODUCTION: We investigated the predictive capacity of mid-trimester cervical length (CL) measurement for spontaneous and iatrogenic preterm birth. MATERIAL AND METHODS: We performed a prospective observational cohort study in nulliparous women and low-risk multiparous women with a singleton pregnancy between 16(+0) and 21(+6) weeks of gestation. We assessed the prognostic capacity of transvaginally measured mid-trimester CL for spontaneous and iatrogenic preterm birth (

Objective To test the hypothesis that in pregnancies with a clinically suspected growth restricted foetus at term, induction of labour is as safe as expectant management, and does not lead to increased obstetrical interventions or perinatal morbidity. Study design In one obstetric centre, 33 women with a clinically suspected growth restricted foetus at term were randomly allocated after stratification for parity to either induction or to expectant management. Obstetric and neonatal outcome variables were compared. Results There was a lower gestational age at labour (median 380 weeks versus 401 weeks) with a corresponding tendency to lower birth weight (mean 2428 g versus 2651 g), and a reduced need for ante partum medical surveillance, in the induction group. No significant differences in obstetrical interventions (25% versus 24%) and neonatal morbidity rates (50% versus 35%) were found. Conclusion A larger multicenter study with a sufficient power and long-term follow-up to decide the best policy for the term growth restricted foetus is feasible.

The majority of neonatal Herpes Simplex Virus (HSV) infections are acquired at birth as a consequence of direct fetal contact with the infected birth canal or through an ascending infection after premature rupture of the amniotic membranes. Intrauterine transmission of HSV infection from mother to the fetus is rare; in only 5% of the cases it occurs from haematogenous transplacental dissemination. We present a case of transplacental intrauterine HSV infection after a primary maternal HSV infection in the first trimester of pregnancy. The diagnosis was assessed by viral culture and serologic tests. Ultrasound imaging revealed fetal brain damage in the third trimester. Finally, the MRI showed the devastating extensiveness of the HSV infection, which was beyond the expectation based on the ultrasound images.

The aim of the study was to investigate the prevalence of vulvar vestibulitis syndrome (VVS) in a sample of women suffering from lifelong vaginismus (N=91). Lifelong vaginismus is defined as "having a history of never having been able to experience penile entry of the vagina". The results with respect to VVS are compared with the results of women who are suffering from pain during intercourse (superficial dyspareunia) (N = 84). Both patients groups were recruited from two treatment outcome studies. Using a standard physical examination, erythema was found in 77%, pain "on touch" in 69% and erythema and pain on the same location was seen in 56% of the patients with lifelong vaginismus. Furthermore, it was found that erythema (94%), pain (98%) and erythema and pain on the same location (92%) were more frequently found in patients with dyspareunia compared to women with lifelong vaginismus. It is concluded that pain is an integral part of the experiences in the majority of women with lifelong vaginismus.

Contains fulltext : 48774.pdf (Publisher’s version ) (Closed access) OBJECTIVE: Evidence is accumulating that fetal growth is influenced by preexisting maternal disorder(s) hampering endothelial function. We tested the hypothesis that in nonpregnant normotensive, formerly preeclamptic women, vascular function predicts the development of fetal growth restriction. METHODS: In 60 formerly preeclamptic women, we measured central hemodynamic and vascular and clotting function mid follicular phase during the menstrual cycle. Inclusion for final analysis required besides normotension, a subsequent singleton pregnancy, established within 1 year after the prepregnant evaluation and ongoing beyond 16 weeks' gestation. In the ongoing pregnancy we determined birth weight and birth weight percentile. RESULTS: Among 60 formerly preeclamptic women, 45 (75%) were normotensive. Thirty-one (69%) participants succeeded in establishing an ongoing pregnancy within 1 year and were included for final analysis. Of the 31 subsequent pregnancies, 8 (26%) were complicated by fetal growth restriction. Prepregnant left and right uterine artery pulsatility index (PI) correlated inversely with carotid artery compliance ( r = 0.57, P = .005, r = 0.62, P = .002) and venous compliance ( r = 0.49, P = .02 and r = 0.45, P = .04, respectively). The latter, in turn, correlates with plasma volume ( r = 0.63, P = .001) and total peripheral vascular resistance index ( r = -0.45, P = .02). Finally, prepregnant left and right uterine artery PI correlated inversely with subsequent achieved fetal growth ( r = -0.68, P < .0001 and r = -0.58, P = .001, respectively). CONCLUSION: In nonpregnant normotensive, formerly preeclamptic women, an elevated uterine artery PI predisposes to subsequent restriction in fetal growth.

Arch Dis Child Fetal Neonatal Ed 2012;97(Supp 1):A1–A125 A7 4.5 NEONATAL MORBIDITY AFTER INDUCTION VERSUS EXPECTANT MONITORING IN INTRAUTERINE GROWTH RESTRICTION AT TERM KE Boers1, JG Thornton2, SA Scherjon3 1Bronovo Hospital, The Hague, Netherlands; 2University of Nottingham, Nottingham, United Kingdom; 3Leiden University Medical Centre, Leiden, Netherlands 10.1136/fetalneonatal-2012-301809.20 Objective In our recent DIGITAT trial, (Disproportionate Intrauterine Growth Intervention Trial at Term) there was no difference in the primary neonatal composite outcome, but after allocation to induction neonates were admitted more frequently to an intermediate type of fetal care. We wished to test whether this was a protocol driven effect, or based on a true difference in neonatal morbidity, by comparing neonatal morbidity directly using the morbidity assessment index for newborns (MAIN) score. Study design We used data from the DIGITAT-trial, a randomised study comparing induction and expectant management in term IUGR. In each of the neonates, we calculated the MAIN score, a validated outcome scale. Results There were no signifi cant differences in mean MAIN scores (46 induction vs. 52 expectant; mean difference -6; 95% CI [-24;12]), nor in MAIN morbidity categories. Neonatal admissions were lower after 38 weeks gestational age compared to 36 and 37 weeks in both groups. Conclusions The lack of difference in neonatal morbidity in women with IUGR at term is reassuring for the induction of labour policy, and suggests that the apparent increase in intermediate level admission was protocol driven rather than a marker of real morbidity. The observation that neonatal admissions are lowest after 38 weeks supports delaying an induction policy to pre-empt possible stillbirth until this gestation. Trial Register number: ISRCTN10363217 02_fetalneonatal-2012-301809.indd Sec1:7 3/25/2012 6:04:50 PM group.bmj.com on June 26, 2017 Published by http://fn.bmj.com/ Downloaded from

The Wolf-Hirschhorn syndrome (WHS) is a contiguous gene deletion syndrome associated with a hemizygous deletion of chromosome 4p16.3. It is characterized by pre- and postnatal growth restriction, microcephaly, profound learning disability and seizure disorder, a ‘Greek helmet’ facies, and closure defects (cleft lip or palate, coloboma of the eye and cardiac septal defects). Prenatal diagnosis of the WHS (deletion 4p syndrome) has been established after karyotyping mainly for intrauterine growth restriction often with hypospadias, facial clefting and diaphragmatic hernia. Here we report the prenatal diagnosis of WHS at 19 weeks with increased nuchal translucency at 12 weeks, but a favourable integrated screening test due to low levels of B-human chorionic gonadotrophin (hCG). Low levels of hCG have been previously reported in Wolf-Hirschhorn syndrome.

Aarskog syndrome (faciogenital dysplasia, facio-digito-genital syndrome, Aarskog–Scott syndrome, OMIM 305400) is a rare, clinically and genetically heterogeneous X-linked recessive condition characterized by facial dysmorphic features, short stature, brachydactyly and genital anomalies. The prenatal diagnosis of Aarskog syndrome has only been made in the third trimester in high-risk families. This case describes a pregnancy with facial dysmorphism from 12 weeks gestation and associated growth restriction from the second trimester, postnatally diagnosed as the Aarskog syndrome. It shows the value of three-dimensional ultrasound in the evaluation of facial dysmorphism.

Contains fulltext : 137445.pdf (Publisher’s version ) (Open Access) BACKGROUND: Babies born after midtrimester preterm prelabour rupture of membranes (PPROM) are at risk to develop neonatal pulmonary hypoplasia. Perinatal mortality and morbidity after this complication is high. Oligohydramnios in the midtrimester following PPROM is considered to cause a delay in lung development. Repeated transabdominal amnioinfusion with the objective to alleviate oligohydramnios might prevent this complication and might improve neonatal outcome. METHODS/DESIGN: Women with PPROM and persisting oligohydramnios between 16 and 24 weeks gestational age will be asked to participate in a multi-centre randomised controlled trial. Intervention: random allocation to (repeated) abdominal amnioinfusion (intervention) or expectant management (control). The primary outcome is perinatal mortality. Secondary outcomes are lethal pulmonary hypoplasia, non-lethal pulmonary hypoplasia, survival till discharge from NICU, neonatal mortality, chronic lung disease (CLD), number of days ventilatory support, necrotizing enterocolitis (NEC), periventricular leucomalacia (PVL) more than grade I, severe intraventricular hemorrhage (IVH) more than grade II, proven neonatal sepsis, gestational age at delivery, time to delivery, indication for delivery, successful amnioinfusion, placental abruption, cord prolapse, chorioamnionitis, fetal trauma due to puncture. The study will be evaluated according to intention to treat. To show a decrease in perinatal mortality from 70% to 35%, we need to randomise two groups of 28 women (two sided test, beta-error 0.2 and alpha-error 0.05). DISCUSSION: This study will answer the question if (repeated) abdominal amnioinfusion after midtrimester PPROM with associated oligohydramnios improves perinatal survival and prevents pulmonary hypoplasia and other neonatal morbidities. Moreover, it will assess the risks associated with this procedure. TRIAL REGISTRATION: NTR3492 Dutch Trial Register (http://www.trialregister.nl).

Objective To investigate whether vaginal Group B Streptococcus (GBS) colonisation or other baseline characteristics of women with preterm premature rupture of membranes (PPROM) can help in identifying subgroups of women who would benefit from immediate delivery.Design Secondary analysis of the PPROMEXIL trials.Setting Sixty hospitals in the Netherlands.Population Women with PPROM between 34 and 37 weeks of gestation.Methods Random assignment of 723 women to immediate delivery or expectant management.Main outcome measures Early onset neonatal sepsis.Results Vaginal GBS colonisation status was the only marker which was significantly associated with the benefit of immediate delivery (P for interaction: 0.04). GBS colonisation was observed in 14% of women. The risk of early onset neonatal sepsis in GBS-positive women was high (15.2%) when they were managed expectantly but this risk was reduced to 1.8% with immediate delivery. The early onset neonatal sepsis risk was much lower in neonates of GBS-negative women: 2.6% after expectant management and 2.9% with immediate delivery. We estimated that by inducing labour only in GBS-positive women, there would be a 10.4% increase in term delivery rate, while keeping neonatal sepsis and caesarean delivery rates comparable to a strategy of labour induction for all.Conclusions Our post hoc findings suggest that women with PROM between 34 and 37 weeks might benefit from immediate delivery if they have GBS vaginal colonisation, while in GBS-negative women labour induction could be delayed until 37 weeks.

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.

Objective: Women with late preterm premature rupture of membranes (PROM) have an increased risk that their child will develop neonatal sepsis. We evaluated whether neonatal sepsis can be predicted from antepartum parameters in these women.Study design: We used multivariable logistic regression to develop a prediction model. Data were obtained from two recent randomized controlled trials on induction of labor versus expectant management in late preterm PROM (PPROMEXIL trials, (ISRCTN29313500 and ISRCTN05689407). Data from randomized as well as non-randomized women, who consented to the use of their medical data, were used. We evaluated 13 potential antepartum predictors for neonatal sepsis. Missing data were imputed. Discriminative ability of the model was expressed as the area under the receiver operating characteristic (ROC) curve and a calibration with both a calibration plot and the Hosmer and Lemeshow goodness-of-fit test. Overall performance of the prediction model was quantified as the scaled Brier score.Results: We studied 970 women. Thirty-three (3.4%) neonates suffered neonatal sepsis. Maternal age (OR 1.09 per year), maternal CRP level (OR 1.01 per mmol/l), maternal temperature (OR 1.80 per degrees C) and positive GBS culture (OR 2.20) were associated with an increased risk of neonatal sepsis. The model had an area under the ROC-curve of 0.71. The model had both a good calibration and accuracy.Conclusions: Antepartum parameters aid in the more precise prediction of the risk of neonatal sepsis in women with late preterm PPROM. (C) 2014 Elsevier Ireland Ltd. All rights reserved.

Contains fulltext : 118346.pdf (Publisher’s version ) (Open Access) IMPORTANCE: In threatened preterm labor, maintenance tocolysis with nifedipine, after an initial course of tocolysis and corticosteroids for 48 hours, may improve perinatal outcome. OBJECTIVE: To determine whether maintenance tocolysis with nifedipine will reduce adverse perinatal outcomes due to premature birth. DESIGN, SETTING, AND PARTICIPANTS: APOSTEL-II (Assessment of Perinatal Outcome with Sustained Tocolysis in Early Labor) is a double-blind, placebo-controlled trial performed in 11 perinatal units including all tertiary centers in The Netherlands. From June 2008 to February 2010, women with threatened preterm labor between 26 weeks (plus 0 days) and 32 weeks (plus 2 days) gestation, who had not delivered after 48 hours of tocolysis and a completed course of corticosteroids, were enrolled. Surviving infants were followed up until 6 months after birth (ended August 2010). INTERVENTION: Randomization assigned 406 women to maintenance tocolysis with nifedipine orally (80 mg/d; n = 201) or placebo (n = 205) for 12 days. Assigned treatment was masked from investigators, participants, clinicians, and research nurses. MAIN OUTCOME MEASURES: Primary outcome was a composite of adverse perinatal outcomes (perinatal death, chronic lung disease, neonatal sepsis, intraventricular hemorrhage >grade 2, periventricular leukomalacia >grade 1, or necrotizing enterocolitis). Analyses were completed on an intention-to-treat basis. RESULTS: Mean (SD) gestational age at randomization was 29.2 (1.7) weeks for both groups. Adverse perinatal outcome was not significantly different between groups: 11.9% (24/201; 95% CI, 7.5%-16.4%) for nifedipine vs 13.7% (28/205; 95% CI, 9.0%-18.4%) for placebo (relative risk, 0.87; 95% CI, 0.53-1.45). CONCLUSIONS AND RELEVANCE: In patients with threatened preterm labor, nifedipine-maintained tocolysis did not result in a statistically significant reduction in adverse perinatal outcomes when compared with placebo. Although the lower than anticipated rate of adverse perinatal outcomes in the control group indicates that a benefit of nifedipine cannot completely be excluded, its use for maintenance tocolysis does not appear beneficial at this time. TRIAL REGISTRATION: trialregister.nl Identifier: NTR1336.

Objective Midtrimester preterm prelabor rupture of membranes (PPROM) has a high rate of neonatal mortality and morbidity. The aim of this study was to study outcomes of subsequent pregnancies after a pregnancy with PPROM before 27 weeks' gestation. Study Design Retrospective study of subsequent pregnancies of women who suffered PPROM before 27 weeks' gestation from 1994 to 2009. The main outcome measure was the risk of recurrence of PPROM before 27 weeks' gestation. The authors also studied preterm birth and pregnancy outcome in the subsequent pregnancy. Finally, they assessed associative factors for subsequent premature delivery. Results They identified 307 patients, of whom 118 women had a subsequent pregnancy. Of 99 women with complete outcome data, 9 women (9%) had PPROM before 27 weeks' gestation in a subsequent pregnancy and 35 women (35%) had a preterm delivery. In 58 (59%) of pregnancies no major complications occurred. They found three associative factors for premature delivery in a subsequent pregnancy: negative vaginal culture for Group B streptococcus, increasing maternal age and early gestational age at PPROM in the index pregnancy. Conclusions Women with PPROM before 27 weeks have a 9% recurrence risk of early PPROM and a risk of 35% of having a preterm delivery in a subsequent pregnancy.

Background Preterm prelabour rupture of membranes (PPROM) before 26 weeks can delay lung development and can cause pulmonary hypoplasia, as a result of oligohydramnios. Restoring the amniotic fluid volume by transabdominal amnioinfusion might prevent abnormal lung development and might have a protective effect for neurological complications, fetal deformities and neonatal sepsis. Objectives To assess the effectiveness of transabdominal amnioinfusion in improving perinatal outcome in women with oligohydramnios secondary to rupture of fetal membranes before 26 weeks. Search methods We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 April 2013). Selection criteria All randomised controlled trials comparing transabdominal amnioinfusion with no transabdominal amnioinfusion. Cluster- or quasi-randomised trials were not eligible for inclusion. In cases where only an abstract was available, we attempted to find the full articles. Data collection and analysis Two review authors assessed trials for inclusion. No eligible trials were identified. Main results There are no included studies. Authors' conclusions There is currently no evidence to evaluate the use of transabdominal amnioinfusion in women with oligohydramnios secondary to rupture of fetal membranes before 26 weeks for improving perinatal outcome. Further research examining the effects of this intervention is needed. Two randomised controlled trials are ongoing but final data have not yet been published.

Contains fulltext : 172293.PDF (Publisher’s version ) (Open Access) BACKGROUND: There is an ongoing discussion on the rising CS rate worldwide. Suboptimal guideline adherence may be an important contributor to this rise. Before improvement of care can be established, optimal CS care in different settings has to be defined. This study aimed to develop and measure quality indicators to determine guideline adherence and identify target groups for improvement of care with direct effect on caesarean section (CS) rates. METHOD: Eighteen obstetricians and midwives participated in an expert panel for systematic CS quality indicator development according to the RAND-modified Delphi method. A multi-center study was performed and medical charts of 1024 women with a CS and a stratified and weighted randomly selected group of 1036 women with a vaginal delivery were analysed. Quality indicator frequency and adherence were scored in 2060 women with a CS or vaginal delivery. RESULTS: The expert panel developed 16 indicators on planned CS and 11 indicators on unplanned CS. Indicator adherence was calculated, defined as the number of women in a specific obstetrical situation in which care was performed as recommended in both planned and unplanned CS settings. The most frequently occurring obstetrical situations with low indicator adherence were: 1) suspected fetal distress (frequency 17%, adherence 46%), 2) non-progressive labour (frequency 12%, CS performed too early in over 75%), 3) continuous support during labour (frequency 88%, adherence 37%) and 4) previous CS (frequency 12%), with adequate counselling in 15%. CONCLUSIONS: We identified four concrete target groups for improvement of obstetrical care, which can be used as a starting point to reduce CS rates worldwide.

OBJECTIVE: The evidence for the management of near term prelabor rupture of membranes is poor. From January 2007 until September 2009, we performed the PPROM Expectant Management versus Induction of Labor (PPROMEXIL) trial. In this trial, we showed that in women with preterm prelabor rupture of membranes (PPROM), the incidence of neonatal sepsis was low, and the induction of labor (IoL) did not reduce this risk. Because the PPROMEXIL trial was underpowered and because of a lower-than-expected incidence of neonatal sepsis, we performed a second trial (PPROMEXIL-2), aiming to randomize 200 patients to improve the evidence in near-term PPROM.STUDY DESIGN: In a nationwide multicenter study, nonlaboring women with PPROM between 34 and 37 weeks' gestational age were eligible for inclusion. Patients were randomized to IoL or expectant management (EM). The primary outcome measure was neonatal sepsis.RESULTS: From December 2009 until January 2011, we randomized 100 women to IoL and 95 to EM. Neonatal sepsis was seen in 3 neonates (3.0%) in the IoL-group versus 4 neonates (4.1%) in the EM group (relative risk, 0.74; 95% confidence interval, 0.17-3.2). One of the sepsis cases in the IoL group resulted in neonatal death because of asphyxia. There were no significant differences in secondary outcomes.CONCLUSION: The risk of neonatal sepsis after PPROM near term is low. Induction of labor does not reduce this risk.

We sought to predict neonatal metabolic acidosis at birth using antepartum obstetric characteristics (model 1) and additional characteristics available during labor (model 2). In 5667 laboring women from a multicenter randomized trial that had a high-risk singleton pregnancy in cephalic presentation beyond 36 weeks of gestation, we predicted neonatal metabolic acidosis. Based on literature and clinical reasoning, we selected both antepartum characteristics and characteristics that became available during labor. After univariable analyses, the predictors of the multivariable models were identified by backward stepwise selection in a logistic regression analysis. Model performance was assessed by discrimination and calibration. To correct for potential overfitting, we (internally) validated the models with bootstrapping techniques. Of 5667 neonates born alive, 107 (1.9%) had metabolic acidosis. Antepartum predictors of metabolic acidosis were gestational age, nulliparity, previous cesarean delivery, and maternal diabetes. Additional intrapartum predictors were spontaneous onset of labor and meconium-stained amniotic fluid. Calibration and discrimination were acceptable for both models (c-statistic 0.64 and 0.66, respectively). In women with a high-risk singleton term pregnancy in cephalic presentation, we identified antepartum and intrapartum factors that predict neonatal metabolic acidosis at birth.

Purpose. To evaluate reproducibility of fetal renal pelvis volume as assessed by the Virtual Organ Computer Aided AnaLysis (VOCAL) imaging program and by Automatic Volume Calculation (SonoAVC). In addition, the intra- and interobserver reliability of fetal renal pelvis volume measurements with SonoAVC were established. Methods. In this study, the fetal renal pelvis volume was measured using 3D ultrasonography in 76 kid- neys of 66 fetuses with renal pelvis dilatation in the second or third trimester of pregnancy. After volume acquisition by one observer, the reproducibility of volume calculation was assessed using VOCAL imag- ing program and SonoAVC by two observers. Intra- and interobserver reproducibility was evaluated by calculating intraclass correlation coefficients (ICC), coefficient of variation (CV) and repeatability coeffi- cient (r). Bland-Altman plots were generated to explore agreement. Results. A high degree of reproducibility was observed between VOCAL and SonoAVC, ICC of 0.989; 95% CI 0.983-0.993, respectively. Intraobserver reproducibility of volume measure- ments performed by SonoAVC demonstrated a high degree of reliability with ICC of 0.995 (95% CI 0.993- 0.997), CV 6.05% and r of 0.75. The interobserver reproducibility with ICC of 0.995 (95% CI 0.992-0.997), CV 10.14% and r 1.21 was also indicative of good reliability. Conclusion. Volume measurements of fetal renal pelvis performed by SonoAVC renders reproducible measurements in comparison with the VOCAL imag- ing program. There is no significant difference between VOCAL imaging program and SonoAVC. The intra- and interobserver reliability of the fetal renal pel- vis measurements made by SonoAVC were consid- ered to be very good. SonoAVC, however, needs post processing in the majority of cases but is less time consuming than VOCAL. V C 2013 Wiley Periodicals, Inc. J Clin Ultrasound 00:000-000, 2013; Published online in Wiley Online Library (wileyonlinelibrary. com). DOI: 10.1002/jcu.22039

Contains fulltext : 108337.pdf (Publisher’s version ) (Open Access) BACKGROUND: At present, there is insufficient evidence to guide appropriate management of women with preterm prelabor rupture of membranes (PPROM) near term. METHODS AND FINDINGS: We conducted an open-label randomized controlled trial in 60 hospitals in The Netherlands, which included non-laboring women with >24 h of PPROM between 34(+0) and 37(+0) wk of gestation. Participants were randomly allocated in a 1:1 ratio to induction of labor (IoL) or expectant management (EM) using block randomization. The main outcome was neonatal sepsis. Secondary outcomes included mode of delivery, respiratory distress syndrome (RDS), and chorioamnionitis. Patients and caregivers were not blinded to randomization status. We updated a prior meta-analysis on the effect of both interventions on neonatal sepsis, RDS, and cesarean section rate. From 1 January 2007 to 9 September 2009, 776 patients in 60 hospitals were eligible for the study, of which 536 patients were randomized. Four patients were excluded after randomization. We allocated 266 women (268 neonates) to IoL and 266 women (270 neonates) to EM. Neonatal sepsis occurred in seven (2.6%) newborns of women in the IoL group and in 11 (4.1%) neonates in the EM group (relative risk [RR] 0.64; 95% confidence interval [CI] 0.25 to 1.6). RDS was seen in 21 (7.8%, IoL) versus 17 neonates (6.3%, EM) (RR 1.3; 95% CI 0.67 to 2.3), and a cesarean section was performed in 36 (13%, IoL) versus 37 (14%, EM) women (RR 0.98; 95% CI 0.64 to 1.50). The risk for chorioamnionitis was reduced in the IoL group. No serious adverse events were reported. Updating an existing meta-analysis with our trial results (the only eligible trial for the update) indicated RRs of 1.06 (95% CI 0.64 to 1.76) for neonatal sepsis (eight trials, 1,230 neonates) and 1.27 (95% CI 0.98 to 1.65) for cesarean section (eight trials, 1,222 women) for IoL compared with EM. CONCLUSIONS: In women whose pregnancy is complicated by late PPROM, neither our trial nor the updated meta-analysis indicates that IoL substantially improves pregnancy outcomes compared with EM. TRIAL REGISTRATION: Current Controlled Trials ISRCTN29313500

Item does not contain fulltext OBJECTIVE: Gestational hypertension (GH) and preeclampsia (PE) are major contributors to maternal and neonatal morbidity and mortality. In GH or PE, labor may be either induced or monitored expectantly. We studied maternal health-related quality of life (HR-QoL) after induction of labor versus expectant monitoring in GH or PE at term. We performed the HR-QoL study alongside a multicenter randomized controlled trial comparing induction of labor to expectant monitoring in women with GH or PE after 36 weeks. METHODS: We used written questionnaires, covering background characteristics, condition-specific issues, and validated measures: the Short-Form (SF-36), European Quality of Life (EuroQoL 6D3L), Hospital Anxiety and Depression Scale (HADS), and Symptom Checklist (SCL-90). Measurements were at the following time points: baseline, 6 weeks postpartum, and 6 months postpartum. A multivariate mixed model with repeated measures was defined to assess the effect of the treatments on the physical component score (PCS) and mental component score (MCS) of the SF-36. Analysis was by intention to treat. RESULTS: We analyzed the data of 491 randomized and 220 nonrandomized women. We did not find treatment effect on long-term HR-QoL (PCS: p = 0.09; MCS: p = 0.82). The PCS improved over time (p < 0.001) and was better in nonrandomized patients (p = 0.02). CONCLUSION: Despite a clinical benefit of induction of labor, long-term HR-QoL is equal after the induction of labor and expectant management in women with GH or PE beyond 36 weeks of gestation.

Contains fulltext : 96560.pdf (Publisher’s version ) (Closed access) OBJECTIVE: To estimate whether administration of 17alpha-hydroxyprogesterone caproate can prevent neonatal morbidity in multiple pregnancies by reducing the preterm birth rate. METHODS: We conducted a multicenter, double-blind, placebo-controlled randomized trial in 55 obstetric clinics in the Netherlands. Women with a multiple pregnancy were randomized to weekly injections of either 250 mg 17alpha-hydroxyprogesterone caproate or placebo, starting between 16 and 20 weeks of gestation and continuing until 36 weeks of gestation. The main outcome measure was adverse neonatal outcome. Secondary outcome measures were gestational age at delivery and delivery before 28, 32, and 37 weeks of gestation. RESULTS: We randomized 671 women. A composite measure of adverse neonatal outcome was present in 110 children (16%) born to mothers in the 17alpha-hydroxyprogesterone caproate group, and in 80 children (12%) of mothers in the placebo group (relative risk [RR] 1.34; 95% confidence interval [CI] 0.95-1.89). The mean gestational age at delivery was 35.4 weeks for the 17alpha-hydroxyprogesterone caproate group and 35.7 weeks for the placebo group (P=.32). Treatment with 17alpha-hydroxyprogesterone caproate did not reduce the delivery rate before 28 weeks (6% in the 17alpha-hydroxyprogesterone caproate group compared with 5% in the placebo group, RR 1.04; 95% CI 0.56-1.94), 32 weeks (14% compared with 10%, RR 1.37; 95% CI 0.91-2.05), or 37 weeks of gestation (55% compared with 50%, RR 1.11; 95% CI 0.97-1.28). CONCLUSION: 17alpha-hydroxyprogesterone caproate does not prevent neonatal morbidity or preterm birth in multiple pregnancies. CLINICAL TRIAL REGISTRATION: ISRCTN Register, www.isrctn.org, ISRCTN40512715.

Background Hypoxic-ischaemic encephalopathy is associated with development of cerebral palsy and cognitive disability later in life and is therefore one of the fundamental problems in perinatal medicine. The xanthine-oxidase inhibitor allopurinol reduces the formation of free radicals, thereby limiting the amount of hypoxia-reperfusion damage. In case of suspected intra-uterine hypoxia, both animal and human studies suggest that maternal administration of allopurinol immediately prior to delivery reduces hypoxic-ischaemic encephalopathy. Methods/Design The proposed trial is a randomized double blind placebo controlled multicenter study in pregnant women at term in whom the foetus is suspected of intra-uterine hypoxia. Allopurinol 500 mg IV or placebo will be administered antenatally to the pregnant woman when foetal hypoxia is suspected. Foetal distress is being diagnosed by the clinician as an abnormal or non-reassuring foetal heart rate trace, preferably accompanied by either significant ST-wave abnormalities (as detected by the STAN-monitor) or an abnormal foetal blood scalp sampling (pH < 7.20). Primary outcome measures are the amount of S100B (a marker for brain tissue damage) and the severity of oxidative stress (measured by isoprostane, neuroprostane, non protein bound iron and hypoxanthine), both measured in umbilical cord blood. Secondary outcome measures are neonatal mortality, serious composite neonatal morbidity and long-term neurological outcome. Furthermore pharmacokinetics and pharmacodynamics will be investigated. We expect an inclusion of 220 patients (110 per group) to be feasible in an inclusion period of two years. Given a suspected mean value of S100B of 1.05 ug/L (SD 0.37 ug/L) in the placebo group this trial has a power of 90% (alpha 0.05) to detect a mean value of S100B of 0.89 ug/L (SD 0.37 ug/L) in the 'allopurinol-treated' group (z-test2-sided). Analysis will be by intention to treat and it allows for one interim analysis. Discussion In this trial we aim to answer the question whether antenatal allopurinol administration reduces hypoxic-ischaemic encephalopathy in neonates exposed to foetal hypoxia. Trial registration number Clinical Trials, protocol registration system: NCT00189007

Contains fulltext : 79491.pdf (Publisher’s version ) (Open Access) BACKGROUND: Multiple pregnancies are at high risk for preterm birth, and therefore an important cause of infant mortality and morbidity. A pessary is a simple and potentially effective measure for the prevention of preterm birth. Small studies have indicated its effectiveness, but large studies with sufficient power on the subject are lacking. Despite this lack of evidence, the treatment is at present applied by some gynaecologists in The Netherlands. METHODS/DESIGN: We aim to investigate the hypothesis that prophylactic use of a cervical pessary will be effective in the prevention of preterm delivery and the neonatal mortality and morbidity resulting from preterm delivery in multiple pregnancy. We will evaluate the costs and effects of this intervention. At study entry, cervical length will be measured. Eligible women will be randomly allocated to receive either a cervical pessary or no intervention. The cervical pessary will be placed in situ at 16 to 20 weeks, and will stay in situ up to 36 weeks gestation or until delivery, whatever comes first.The primary outcome is composite bad neonatal condition (perinatal death or severe morbidity). Secondary outcome measures are time to delivery, preterm birth rate before 32 and 37 weeks, days of admission in neonatal intensive care unit, maternal morbidity, maternal admission days for preterm labour and costs. We need to include 660 women to indicate a reduction in bad neonatal outcome from 7.2% without to 3.9% with a cervical pessary, using a two-sided test with an alpha of 0.05 and a power of 0.80. DISCUSSION: This trial will provide evidence on whether a cervical pessary will decrease the incidence of early preterm birth and its concomitant bad neonatal outcome in multiple pregnancies. TRIAL REGISTRATION: Current Controlled Trials: NTR 1858.

Contains fulltext : 79641.pdf (Publisher’s version ) (Open Access) BACKGROUND: At present, women with threatened preterm labor before 32 weeks of gestation are, after transfer to a perinatal center, treated with tocolytics and corticosteroids. Many of these women are treated unnecessarily. Fibronectin is an accurate predictor for the occurrence of preterm birth among women with threatened preterm labor. We will assess whether triage of these women with fibronectin testing, cervical length or their combination is cost-effective. METHODS/DESIGN: We will investigate a prospective cohort of women referred to a perinatal centre for spontaneous threatened preterm labor between 24 and 34 weeks with intact membranes. All women will be tested for fibronectin and cervical length. Women with a cervical length 30 mm will be managed according to local protocol. Corticosteroids may be given to all women at the discretion of the attending physician. Primary outcome measure will be delivery within 7 days. Secondary outcome measures will be neonatal morbidity and mortality, complications of tocolytics, costs and health related quality of life. The analysis will be according to the intention to treat principle. We anticipate the probability on preterm birth within 7 days in the group of women with a negative fibronectine test to be 5%. Two groups of 110 women will be needed to assure that in case of non-inferiority the difference in the proportion of preterm deliveries < 7 days will be within a prespecified boundary of 7.5% (one sided test, beta 0.2, alpha 0.05). Data obtained from women with a positive and negative fibronectin tests in both the cohort study and the trial will be integrated in a cost-effectiveness analysis that will assess economic consequences of the use of fibronectin. DISCUSSION: This study will provide evidence for the use of fibronectin testing as safe and cost-effective method in a triage for threatened preterm labor. TRIAL REGISTRATION: Nederlands Trial Register (NTR) number 1857, http://www.trialregister.nl.

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.

Objective To assess the reproducibility of fetal renal pelvis volume measurement in hydronephrotic kidneys using transabdominal three-dimensional (3D) ultrasound. Methods The fetal renal pelvis volume was measured using 3D ultrasound in one kidney in each of 15 fetuses with hydronephrosis in the second or third trimester of pregnancy. Hydronephrosis was diagnosed when the fetus had an anteroposterior renal pelvis diameter ≥ 5 mm. After volume acquisition by one of the observers, the repeatability of volume calculation with manual delineation of the fetal renal pelvis was assessed by six different observers using the Virtual Organ Computer-aided AnaLysis (VOCAL™) imaging program. The intraclass correlation coefficients (ICC), coefficient of variation (CV) and within- and between-observer repeatability coefficient (r) were calculated and Bland–Altman plots were constructed. Results Both intra- and interobserver reliability of the fetal renal pelvis volume measurements were considered to be very good. For intraobserver reliability, the ICC was 0.996 and the CV was 10.8%. For the overall interobserver reliability, the ICC was 0.998 and the CV was 15.7%; the interobserver reliability between pairs of observers had ICCs between 0.994 and 0.999, and CVs between 19.5% and 7.6% for inexperienced and experienced observers, respectively. Conclusion With 3D ultrasound using the VOCAL imaging program, it is technically feasible to reproduce fetal renal pelvis volume measurements. Further research to establish the clinical applications of this technology is warranted. Copyright © 2008 ISUOG. Published by John Wiley & Sons, Ltd.