Kitty W M Bloemenkamp

Leiden University Medical Centre, Leyden, South Holland, Netherlands

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Publications (168)936.49 Total impact

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    ABSTRACT: Objective Cervical length (CL) is associated with the risk of preterm birth (PTB) in multiple pregnancies. However, the position of CL within the pathophysiological pathway of PTB is unclear, and it is unknown which factors are predictive for CL. This study aims to investigate whether in twin pregnancies baseline maternal and obstetrical characteristics are potential indicators for CL, to improve insight in the pathophysiological pathway of PTB. Study Design Secondary analysis of data on twin pregnancies and CL measurement between 16 and 22 weeks. A set of 10 potential indicators, known to be associated with an increased risk of PTB and/or which have a plausible mechanism resulting in a change of CL were selected. We used multivariable linear regression with backward selection to identify independent indicators for CL. Results A total of 1,447 women with twin pregnancies were included. Mean CL was 43.7 (± 8.9) mm. In multivariable analysis, age (0.27 mm/y; 95% confidence interval [CI] 0.16 to 0.39), use of assisted reproductive technologies (ART) (-1.42 mm, 95% CI -2.6 to -0.25), and having delivered at term in a previous pregnancy (1.32 mm, 95% CI 0.25 to 2.39) were significantly associated with CL. Conclusion This study shows that in twin pregnancies, age, use of ART and having delivered term in a previous pregnancy has an association with CL. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.
    American Journal of Perinatology 04/2015; DOI:10.1055/s-0035-1549396 · 1.60 Impact Factor
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    ABSTRACT: There is little evidence to guide the management of women with hypertensive disorders in late preterm pregnancy. We investigated the effect of immediate delivery versus expectant monitoring on maternal and neonatal outcomes in such women. We did an open-label, randomised controlled trial, in seven academic hospitals and 44 non-academic hospitals in the Netherlands. Women with non-severe hypertensive disorders of pregnancy between 34 and 37 weeks of gestation were randomly allocated to either induction of labour or caesarean section within 24 h (immediate delivery) or a strategy aimed at prolonging pregnancy until 37 weeks of gestation (expectant monitoring). The primary outcomes were a composite of adverse maternal outcomes (thromboembolic disease, pulmonary oedema, eclampsia, HELLP syndrome, placental abruption, or maternal death), and neonatal respiratory distress syndrome, both analysed by intention-to-treat. This study is registered with the Netherlands Trial Register (NTR1792). Between March 1, 2009, and Feb 21, 2013, 897 women were invited to participate, of whom 703 were enrolled and randomly assigned to immediate delivery (n=352) or expectant monitoring (n=351). The composite adverse maternal outcome occurred in four (1·1%) of 352 women allocated to immediate delivery versus 11 (3·1%) of 351 women allocated to expectant monitoring (relative risk [RR] 0·36, 95% CI 0·12-1·11; p=0·069). Respiratory distress syndrome was diagnosed in 20 (5·7%) of 352 neonates in the immediate delivery group versus six (1·7%) of 351 neonates in the expectant monitoring group (RR 3·3, 95% CI 1·4-8·2; p=0·005). No maternal or perinatal deaths occurred. For women with non-severe hypertensive disorders at 34-37 weeks of gestation, immediate delivery might reduce the already small risk of adverse maternal outcomes. However, it significantly increases the risk of neonatal respiratory distress syndrome, therefore, routine immediate delivery does not seem justified and a strategy of expectant monitoring until the clinical situation deteriorates can be considered. ZonMw. Copyright © 2015 Elsevier Ltd. All rights reserved.
    The Lancet 03/2015; DOI:10.1016/S0140-6736(14)61998-X · 39.21 Impact Factor
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    ABSTRACT: To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. Multicentre randomised controlled equivalence trial. 15 hospitals in the Netherlands. Women with an intermediate to high obstetric risk with an intention to deliver vaginally. To exclude a clinically relevant difference in satisfaction with pain relief of more than 10%, we needed to include 1136 women. Because of missing values for satisfaction this number was increased to 1400 before any analysis. We used multiple imputation to correct for missing data. Before the onset of active labour consenting women were randomised to a pain relief strategy with patient controlled remifentanil or epidural analgesia if they requested pain relief during labour. Primary outcome was satisfaction with pain relief, measured hourly on a visual analogue scale and expressed as area under the curve (AUC), thus providing a time weighted measure of total satisfaction with pain relief. A higher AUC represents higher satisfaction with pain relief. Secondary outcomes were pain intensity scores, mode of delivery, and maternal and neonatal outcomes. Analysis was done by intention to treat. The study was defined as an equivalence study for the primary outcome. 1414 women were randomised, of whom 709 were allocated to patient controlled remifentanil and 705 to epidural analgesia. Baseline characteristics were comparable. Pain relief was ultimately used in 65% (447/687) in the remifentanil group and 52% (347/671) in the epidural analgesia group (relative risk 1.32, 95% confidence interval 1.18 to 1.48). Cross over occurred in 7% (45/687) and 8% (51/671) of women, respectively. Of women primarily treated with remifentanil, 13% (53/402) converted to epidural analgesia, while in women primarily treated with epidural analgesia 1% (3/296) converted to remifentanil. The area under the curve for total satisfaction with pain relief was 30.9 in the remifentanil group versus 33.7 in the epidural analgesia group (mean difference -2.8, 95% confidence interval -6.9 to 1.3). For who actually received pain relief the area under the curve for satisfaction with pain relief after the start of pain relief was 25.6 in the remifentanil group versus 36.1 in the epidural analgesia group (mean difference -10.4, -13.9 to -7.0). The rate of caesarean section was 15% in both groups. Oxygen saturation was significantly lower (SpO2 <92%) in women who used remifentanil (relative risk 1.5, 1.4 to 1.7). Maternal and neonatal outcomes were comparable between both groups. In women in labour, patient controlled analgesia with remifentanil is not equivalent to epidural analgesia with respect to scores on satisfaction with pain relief. Satisfaction with pain relief was significantly higher in women who were allocated to and received epidural analgesia. Netherlands Trial Register NTR2551. © Freeman et al 2015.
    BMJ British medical journal 02/2015; 350. DOI:10.1136/bmj.h846 · 16.30 Impact Factor
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    ABSTRACT: PROBLEM The aim of this meta-analysis was to evaluate whether specific maternal HLA alleles and HLA sharing of couples are associated with the occurrence of recurrent miscarriage (RM). METHOD OF STUDY A systematic literature search was performed for studies that evaluated the association between HLA alleles, HLA sharing and RM. RM was defined as three or more consecutive unexplained miscarriages and a control group was included of women with at least one live birth and no miscarriages in their history. Meta-analyses were performed and the pooled odds ratio (OR) was calculated. RESULTS We included 41 studies. Selection bias was present in 40 studies and information bias in all studies. Meta-analyses showed an increased risk of RM in mothers carrying a HLA-DRB1∗4 (OR1.41, 95%CI1.05-1.90), HLA-DRB1∗15 (OR1.57, 95%CI1.15-2.14), or a HLA-E∗01:01 allele (OR1.47, 95%CI .20-1.81), and a decreased risk with HLA-DRB1∗13 (OR0.63, 95%CI0.45-0.89) or HLA-DRB1∗14 (OR0.54, 95%CI0.31-0.94). Pooling results for HLA sharing showed that HLA-B sharing (OR1.39, 95%CI1.11-1.75) and HLA-DR sharing (OR1.57, 95%CI1.10-1.25) were both associated with the occurrence of RM. CONCLUSION Although the present systematic review and meta-analysis demonstrates that specific HLA alleles and HLA sharing are associated with RM, a high degree of bias was present and therefore observed results should be interpreted carefully. Copyright © 2015. Published by Elsevier Inc.
    Human Immunology 02/2015; DOI:10.1016/j.humimm.2015.02.004 · 2.28 Impact Factor
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    ABSTRACT: OBJECTIVE: To compare the effectiveness and safety of nifedipine and atosiban for tocolysis in women with preterm labour on perinatal outcome and prolongation of pregnancy. STUDY DESIGN: In this multicenter randomized clinical trial (Apostel III, NTR 2947), we included women between 25 +0 and 34 +0 weeks of gestation with symptoms of threatened preterm delivery, defined as at least 3 contractions per 30 minutes, and 1) a cervical length of 10 mm or 2) a cervical length of 11-30 mm and a positive fetal Fibronectin test or 3) ruptured membranes. Participants were randomly allocated to either nifedipine or atosiban for 48 hours. The primary outcome was adverse perinatal outcome, defined as a composite of perinatal death, bronchopulmonary dysplasia, culture proven sepsis, intraventricular hemorrhage IIB or worse, periven-tricular leukomalacia II or worse, and necrotising enterocolitis II or worse. Prolongation of pregnancy was a secondary outcome. We needed a total of 500 women to show a reduction in adverse perinatal outcome from 25% to 15%. Analysis was by intention to treat. RESULTS: We allocated 255 women to nifedipine and 256 to atosiban. At writing this abstract, outcome of 481 (94%) pregnancies is known. Gestational age at randomisation was comparable (30.3 (SD 2.4) weeks (Nifedipine) versus 30.2 (SD 2.4) (Atosiban), as were other baseline characteristics. The adverse perinatal outcome rate was 12% versus 12%, RR 1.1; 95%CI 0.64-1.8, Table 1. Median prolongation of pregnancy was 6 days (IQR 1-38 days) in the nifedipine group and 4 days, (IQR 1-30 days) in the atosiban group (HR 0.85; 95% CI 0.68-1.1). Perinatal mortality rate was 5% versus 2%, (RR 2.2; 95% CI 0.86-5.8). CONCLUSION: In women with threatened preterm delivery, nifedipine and atosiban result in similar adverse perinatal outcome rates. A non-significant, but possibly clinically relevant increase in mortality in the nifedipine group questions its safety, and requires further in-depth analysis. Perinatal outcome Abbreviations: BPD Chronic pulmonary dysplasia; IVH intra-ventricular haemorrhage; PVL periventricular leucomalacia; NEC necrotizing enterocolitis; IQR interquartile range. *3/13 deaths might be attributed to congenital defects. # 1/6 deaths might be attributed to congenital defects. $ Calculated using Generalised Estimating Equations to account for independence of children within mothers OBJECTIVE: To evaluate whether induced and/or augmented labor is associated with increased odds of autism spectrum disorder (ASD). STUDY DESIGN: We performed an epidemiological analysis using data from the Utah Registry of Autism and Developmental Disabilities (URADD) and the Utah Department of Health (UDOH) Vital Records and Statistics. URADD ascertains children with ASD within a four county surveillance area (approximately 70% of the Utah population) by querying records from UDOH, clinics, hospitals and
    fmf; 01/2015
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    ABSTRACT: To determine whether maternal allopurinol treatment during suspected fetal hypoxia would reduce the release of biomarkers associated with neonatal brain damage. A randomised double-blind placebo controlled multicentre trial. We studied women in labour at term with clinical indices of fetal hypoxia, prompting immediate delivery. Delivery rooms of 11 Dutch hospitals. When immediate delivery was foreseen based on suspected fetal hypoxia, women were allocated to receive allopurinol 500 mg intravenous (ALLO) or placebo intravenous (CONT). Primary endpoint was the difference in cord S100ß, a tissue-specific biomarker for brain damage. 222 women were randomised to receive allopurinol (ALLO, n=111) or placebo (CONT, n=111). Cord S100ß was not significantly different between the two groups: 44.5 pg/mL (IQR 20.2-71.4) in the ALLO group versus 54.9 pg/mL (IQR 26.8-94.7) in the CONT group (difference in median -7.69 (95% CI -24.9 to 9.52)). Post hoc subgroup analysis showed a potential treatment effect of allopurinol on the proportion of infants with a cord S100ß value above the 75th percentile in girls (ALLO n=5 (12%) vs CONT n=10 (31%); risk ratio (RR) 0.37 (95% CI 0.14 to 0.99)) but not in boys (ALLO n=18 (32%) vs CONT n=15 (25%); RR 1.4 (95% CI 0.84 to 2.3)). Also, cord neuroketal levels were significantly lower in girls treated with allopurinol as compared with placebo treated girls: 18.0 pg/mL (95% CI 12.1 to 26.9) in the ALLO group versus 32.2 pg/mL (95% CI 22.7 to 45.7) in the CONT group (geometric mean difference -16.4 (95% CI -24.6 to -1.64)). Maternal treatment with allopurinol during fetal hypoxia did not significantly lower neuronal damage markers in cord blood. Post hoc analysis revealed a potential beneficial treatment effect in girls. NCT00189007, Dutch Trial Register NTR1383. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
    Archives of Disease in Childhood - Fetal and Neonatal Edition 12/2014; DOI:10.1136/archdischild-2014-306769 · 3.86 Impact Factor
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    ABSTRACT: The APOSTEL-II trial was a multicenter randomized placebo-controlled trial, assessing the effectiveness of maintenance tocolysis with nifedipine. The trial showed maintenance tocolysis not to have an effect on perinatal outcome. Objective of the current study is to evaluate the effect of a negative trial on the length of hospital admission of women with threatened preterm labor. We evaluated length of hospital admission of all patients admitted with threatened preterm labor with a gestational age <32 weeks in 8 perinatal centers that participated in the APOSTEL-II trial. We studied only the first admission with threatened preterm labor, readmissions were excluded. We distinguished between the period before, the period during and the period after the trial. In a subgroup analysis, we differentiated for the group of women who delivered and for the group of women who did not deliver during the initial admission. The mean length of hospital admission was 9.3 days before the start of the trial, 8.4 days during the recruitment period and 8.1 days after the trial was completed. The difference in mean length of hospital admission before and during the recruitment period was significantly different (p<001). The length of hospital admission of women with threatened preterm labor is found to be reduced during the recruitment period of the APOSTEL-II trial. This shows that the conduct of a randomized controlled trial itself has the potential to change daily practice. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
    European Journal of Obstetrics & Gynecology and Reproductive Biology 12/2014; 186C. DOI:10.1016/j.ejogrb.2014.12.003 · 1.63 Impact Factor
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    ABSTRACT: Objective To evaluate whether tocolysis with nifedipine can be omitted in women with symptoms of preterm labor, a shortened cervix, and negative fetal fibronectin test. Study Design A randomized noninferiority trial was performed in all Dutch perinatal centers. Women with symptoms of preterm labor between 24 and 34 weeks, intact membranes, cervical length between 10 and 30 mm, and negative fibronectin test were randomly allocated to nifedipine (80 mg/day) or placebo. The primary outcome was delivery within 7 days. Secondary outcomes were severe neonatal morbidity and mortality. We also followed all eligible nonrandomized women. Results We allocated 37 women to nifedipine and 36 women to placebo. In the nifedipine group, three women (8.1%) delivered within 7 days, compared with one woman (2.8%) in the placebo group (difference -5.3%; one-sided 95% confidence limit 4.5%). Median gestational age at delivery were respectively 37 + 0 (interquartile range [IQR] 34 + 6 to 38 + 5) and 38 + 2 (IQR 37 + 0 to 39 + 6) weeks (p = 0.008). In the nifedipine group, three pregnancies (8.1%) had a poor outcome; there were no poor outcomes in the placebo group. We observed similar trends in eligible nonrandomized women. Conclusion In symptomatic women with preterm labor, a shortened cervix, and negative fibronectin test, placebo treatment is not inferior to tocolysis with nifedipine. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.
    American Journal of Perinatology 12/2014; DOI:10.1055/s-0034-1390346 · 1.60 Impact Factor
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    ABSTRACT: To determine whether in women with a twin pregnancy, mid-trimester cervical length is associated with the risk of emergency caesarean section.
    Ultrasound in Obstetrics and Gynecology 11/2014; DOI:10.1002/uog.14727 · 3.14 Impact Factor
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    ABSTRACT: Objective The aim of this study is to investigate which non-classic cardiovascular biomarkers are associated with persistent endothelial dysfunction after pregnancy in women with a history of hypertensive pregnancy disorders compared to women with uncomplicated pregnancies. Study design Systematic review and meta-analysis of observational studies. A search was performed in PubMed, Embase, Cochrane and Cinahl including articles from inception to 27 February 2013. Included were cohort studies and case-control studies. Cases were women with a history of hypertension in pregnancy, control subjects were women with a history of uncomplicated pregnancies. Of the 3136 found, 21 studies on 16 non-classic cardiovascular biomarkers are described in this review; 12 studies on 5 biomarkers were included in the meta-analysis. Results Women with a history of hypertensive pregnancy disorders had a higher homocysteine level compared to women with a history of uncomplicated pregnancies (5 studies; pooled mean difference 0.77ng/ml; 95% confidence interval 0.27 to 1.26; p <0.01). For the other non-classic cardiovascular biomarkers including markers in areas of inflammation, thrombosis and angiogenesis, we found no significant differences. Conclusion This review and meta-analysis showed that women with a history of hypertensive pregnancy disorders have higher homocysteine levels compared to women with a history of uncomplicated pregnancies. These data suggest persistent endothelial alteration after pregnancies complicated by hypertensive disorders.
    American journal of obstetrics and gynecology 10/2014; 211(4). DOI:10.1016/j.ajog.2014.03.032 · 3.97 Impact Factor
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    ABSTRACT: Preeclampsia is characterized by hypertension and proteinuria, and increased shedding of podocytes into the urine is a common finding. This finding raises the question of whether preeclamptic nephropathy involves podocyte damage. This study examined podocyte-related changes in a unique sample of renal tissues obtained from women who died of preeclampsia.DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: All patients with preeclampsia who died in The Netherlands since 1990 and had available autopsy tissue were identified using a nationwide database of the Dutch Pathology Registry (PALGA). This resulted in a cohort of 11 women who died from preeclampsia. Three control groups were also identified during the same time period, and consisted of normotensive women who died during pregnancy (n=25), and nonpregnant controls either with (n=14) or without (n=13) chronic hypertension. Glomerular lesions, including podocyte numbers, podocyte proliferation, and parietal cell activation, were measured.RESULTS: Patients with preeclampsia had prominent characteristic glomerular lesions. The results showed that the number of podocytes per glomerulus did not differ significantly between the patients with preeclampsia and the control groups. However, preeclampsia was associated with a significant increase in intraglomerular cell proliferation (7.3% [SD 9.4] of the glomeruli of patients with preeclampsia had Ki-67-positive cells versus 1.6% [SD 3.3] of the glomeruli of hypertensive controls and 1.1% [SD 1.3] of nonpregnant controls; P=0.004) and activated parietal epithelial cells on a podocyte location (34% [SD 13.1] of the glomeruli of patients with preeclampsia versus 18.0% [SD 15.3] of pregnant controls, 11.9% [SD 13.2] of hypertensive controls, and 10.8% [SD 13.4] of nonpregnant controls; P=0.01).CONCLUSIONS: These findings suggest that the recently described mechanisms of podocyte replacement play a role in preeclampsia. These results provide key new insights into the pathogenesis of preeclamptic nephropathy, and they open new possibilities for developing therapeutic modalities.
    Clinical Journal of the American Society of Nephrology 07/2014; 9(8). DOI:10.2215/CJN.12811213 · 5.25 Impact Factor
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    ABSTRACT: Objectives To assess the cost-effectiveness of post-partum screening on cardiovascular risk factors and subsequent treatment in women with a history of gestational hypertension or pre-eclampsia at term. Study design Two separate Markov models evaluated the cost-effectiveness analysis of hypertension (HT) screening and screening on metabolic syndrome (MetS), respectively, as compared to current practice in women with a history of term hypertensive pregnancy disorders. Analyses were performed from the Dutch health care perspective, using a lifetime horizon. One-way sensitivity analyses and Monte Carlo simulation evaluated the robustness of the results. Results Both screening on HT and MetS in women with a history of gestational hypertension or pre-eclampsia resulted in increase in life expectancy (HT screening 0.23 year (95% CI −0.06 to 0.54); MetS screening 0.14 years (95% CI −0.16 to 0.45)). The gain in QALYs was limited, with HT screening and MetS screening generating 0.04 QALYs (95% CI −0.12 to 0.20) and 0.03 QALYs (95% CI −0.14 to 0.19), resulting in costs to gain one QALY of €4228 and €28,148, respectively. Analyses for uncertainty showed a chance of 74% and 75%, respectively, that post-partum screening is cost-effective at a threshold of €60,000/QALY. Conclusions According to the available knowledge post-partum screening on cardiovascular risk factors and subsequent treatment in women with a history of gestational hypertension or pre-eclampsia at term is likely to be cost-effective.
    06/2014; DOI:10.1016/j.preghy.2014.06.002
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    ABSTRACT: To estimate the performance of combining cervical length measurement with fetal fibronectin testing in predicting delivery in women with symptoms of preterm labor. We conducted a prospective nationwide cohort study in all 10 perinatal centers in The Netherlands. Women with symptoms of preterm labor between 24 and 34 weeks of gestation with intact membranes were included. In all women, qualitative fibronectin testing (0.050-microgram/mL cutoff) and cervical length measurement were performed. Logistic regression was used to predict spontaneous preterm delivery within 7 days after testing. A risk less than 5%, corresponding to the risk for women with a cervical length of at least 25 mm, was considered as low risk. Between December 2009 and August 2012, 714 women were enrolled. Fibronectin results and cervical length were available for 665 women, of whom 80 (12%) delivered within 7 days. Women with a cervical length of at least 30 mm or with a cervical length between 15 and 30 mm with a negative fibronectin result were at low risk (less than 5%) of spontaneous delivery within 7 days. Fibronectin testing in case of a cervical length between 15 and 30 mm additionally classified 103 women (15% of the cohort) as low risk and 36 women (5% of the cohort) as high risk. Cervical length measurement, combined with fetal fibronectin testing in case of a cervical length between 15 and 30 mm, improves identification of women with a low risk to deliver spontaneously within 7 days. LEVEL OF EVIDENCE:: II.
    Obstetrics and Gynecology 05/2014; DOI:10.1097/AOG.0000000000000229 · 4.37 Impact Factor
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    ABSTRACT: 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 °Celsius) 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.
    European journal of obstetrics, gynecology, and reproductive biology 05/2014; 176. DOI:10.1016/j.ejogrb.2014.02.003 · 1.63 Impact Factor
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    ABSTRACT: Women with multiple gestations often deliver at less than 37 weeks, increasing the risks of perinatal morbidity and mortality. Treatment with a pessary might prevent preterm birth by changing the inclination of the cervical canal and preventing premature dilatation of the cervix, rupture of the membranes, and deterioration or loss of the cervical mucous plug. This multicenter, open-label, randomized controlled trial at 40 hospitals was performed to determine whether a cervical pessary could prevent poor perinatal outcomes in parturients with a multiple pregnancy. At 12 to 20 weeks’ gestation, patients were assigned to the pessary or control group; cervical length was measured at 16 to 22 weeks. Women in the study group received an Arabin pessary at 16 to 20 weeks, which was removed in week 36 or in case of preterm premature rupture of the membranes, active vaginal bleeding, other signs of preterm labor, or patient discomfort. Obstetric care was otherwise similar in the 2 groups. The primary outcome was a composite of poor perinatal outcomes, including stillbirth, preventricular leukomalacia, severe respiratory distress syndrome, bronchopulmonary dysplasia, intraventricular hemorrhage, necrotizing enterocolitis, sepsis, and neonatal death within 6 weeks after the anticipated term date. Secondary outcomes were time to delivery, preterm birth at less than 32 and less than 37 weeks, days in the neonatal intensive care unit, days of maternal admission for preterm labor, and maternal morbidity. A total of 401 of 403 women in the pessary group and 407 of 410 in the control group completed the study. Five women in the pessary group had a surgical cerclage; 1 patient died, and the others delivered at 21.6 to 36.7 weeks, with 3 having poor perinatal outcomes. No patients in the control group had a cerclage. Vaginal discharge occurred in 104 women (26%) in the pessary group and in none of the controls. The pessary was removed from 57 women (14%) at less than 28 weeks and from 22 women (5%) at 28 to 32 weeks; 7 and 13, respectively, delivered within 48 hours of removal. At 32 to 36 weeks, the pessary was removed from 107 women; 70 delivered within 48 hours. The most common reasons for pessary removal in these women were preterm premature rupture of the membranes, vaginal bleeding, contractions, and induction of labor. The composite poor perinatal outcome occurred in 53 women (13%) and 55 women (14%) in the pessary and control groups, respectively (relative risk (RR), 0.98; 95% confidence interval, 0.69–1.39). Ten stillbirths (2%) occurred in each group. The other conditions within the composite outcome did not differ between the 2 groups. In the pessary and control groups, 16 and 18 infants, respectively, died before discharge. The groups were similar in median gestational age at delivery; frequencies of delivery at less than 28, less than 32, and less than 37 weeks; and frequency and length of neonatal intensive care unit admission. In the women with a cervical length of less than 25th percentile (<38 mm), the pessary significantly reduced the frequency of poor perinatal outcomes and very preterm delivery. A cervical pessary does not necessarily prevent poor perinatal outcomes or preterm birth in all women with a multiple gestation. Although the pessary had a positive effect in women with a twin pregnancy and a short cervix, these results should be confirmed in additional prospective studies. The safety and low cost of the pessary should be considered when counseling a parturient with a multiple pregnancy and short cervix.
    Obstetrical and Gynecological Survey 02/2014; 69(2):73-75. DOI:10.1097/01.ogx.0000444676.81634.4a · 2.36 Impact Factor
  • American Journal of Obstetrics and Gynecology 01/2014; 210(1):S2–S3. DOI:10.1016/j.ajog.2013.10.035 · 3.97 Impact Factor
  • American Journal of Obstetrics and Gynecology 01/2014; 210(1):S364. DOI:10.1016/j.ajog.2013.10.774 · 3.97 Impact Factor
  • American Journal of Obstetrics and Gynecology 01/2014; 210(1):S362-S363. DOI:10.1016/j.ajog.2013.10.772 · 3.97 Impact Factor
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    ABSTRACT: Objective The Disproportionate Intrauterine Growth Intervention Trial at Term (DIGITAT trial) showed that in women with suspected intrauterine growth restriction (IUGR) at term, there were no substantial outcome differences between induction of labour and expectant monitoring. The objective of the present analysis is to evaluate whether maternal or fetal markers could identify IUGR fetuses who would benefit from early labour induction. Study design The DIGITAT trial was a multicenter, parallel and open-label randomised controlled trial in women who had a singleton pregnancy beyond 36 + 0 weeks’ gestation with suspected IUGR (n = 650). Women had been randomly allocated to either labour induction or expectant monitoring. The primary outcome was a composite measure of adverse neonatal outcome, defined as neonatal death before hospital discharge, Apgar score <7, umbilical artery pH <7.05, or admission to neonatal intensive care. Using logistic regression modelling, we investigated associations between outcome and 17 markers, maternal characteristics and fetal sonographic and Doppler velocimetry measurements, all collected at study entry. Results 17 (5.3%) infants in the induction group had an adverse neonatal outcome compared to 20 (6.1%) in the expectant monitoring group. The only potentially informative marker for inducing labour was maternal pre-pregnancy body mass index (BMI). Otherwise, we observed at best weak associations between a benefit from labour induction and maternal age, ethnicity, smoking, parity, pregnancy-induced hypertension or preeclampsia, Bishop score and gestational age, or fetal sonographic markers (gender, estimated fetal weight, body measurements, oligohydramnios, or umbilical artery pulsatility index and end diastolic flow). Conclusion In late preterm and term pregnancies complicated by suspected intrauterine growth restriction, most of the known prognostic markers seem unlikely to be helpful in identifying women who could benefit from labour induction, except for maternal pre-pregnancy BMI.
    European journal of obstetrics, gynecology, and reproductive biology 01/2014; 172:20–25. DOI:10.1016/j.ejogrb.2013.10.014 · 1.63 Impact Factor
  • American Journal of Obstetrics and Gynecology 01/2014; 210(1):S399. DOI:10.1016/j.ajog.2013.10.853 · 3.97 Impact Factor

Publication Stats

2k Citations
936.49 Total Impact Points

Institutions

  • 1995–2015
    • Leiden University Medical Centre
      • • Department of Obstetrics
      • • Department of Pathology
      • • Department of Clinical Epidemiology
      Leyden, South Holland, Netherlands
  • 1996–2014
    • Leiden University
      Leyden, South Holland, Netherlands
  • 2012
    • Maastricht Universitair Medisch Centrum
      Maestricht, Limburg, Netherlands
  • 2011
    • Linköping University
      • Department of Clinical and Experimental Medicine (IKE)
      Linköping, Östergötland, Sweden
  • 2004–2011
    • Erasmus MC
      • • Department of Internal Medicine
      • • Department of Obstetrics and Gynaecology
      Rotterdam, South Holland, Netherlands
  • 1999
    • University of Amsterdam
      Amsterdamo, North Holland, Netherlands