Kitty W M Bloemenkamp

Leiden University Medical Centre, Leyden, South Holland, Netherlands

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Publications (197)1143.03 Total impact

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    ABSTRACT: Background Progesterone is essential for the maintenance of pregnancy. However, whether progesterone supplementation in the first trimester of pregnancy would increase the rate of live births among women with a history of unexplained recurrent miscarriages is uncertain. Methods We conducted a multicenter, double-blind, placebo-controlled, randomized trial to investigate whether treatment with progesterone would increase the rates of live births and newborn survival among women with unexplained recurrent miscarriage. We randomly assigned women with recurrent miscarriages to receive twice-daily vaginal suppositories containing either 400 mg of micronized progesterone or matched placebo from a time soon after a positive urinary pregnancy test (and no later than 6 weeks of gestation) through 12 weeks of gestation. The primary outcome was live birth after 24 weeks of gestation. Results A total of 1568 women were assessed for eligibility, and 836 of these women who conceived naturally within 1 year and remained willing to participate in the trial were randomly assigned to receive either progesterone (404 women) or placebo (432 women). The follow-up rate for the primary outcome was 98.8% (826 of 836 women). In an intention-to-treat analysis, the rate of live births was 65.8% (262 of 398 women) in the progesterone group and 63.3% (271 of 428 women) in the placebo group (relative rate, 1.04; 95% confidence interval [CI], 0.94 to 1.15; rate difference, 2.5 percentage points; 95% CI, -4.0 to 9.0). There were no significant between-group differences in the rate of adverse events. Conclusions Progesterone therapy in the first trimester of pregnancy did not result in a significantly higher rate of live births among women with a history of unexplained recurrent miscarriages. (Funded by the United Kingdom National Institute of Health Research; PROMISE Current Controlled Trials number, ISRCTN92644181 .).
    New England Journal of Medicine 11/2015; 373(22):2141-2148. DOI:10.1056/NEJMoa1504927 · 55.87 Impact Factor
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    ABSTRACT: Background: Adverse neonatal outcomes in multiple pregnancies have been documented extensively, in particular those associated with the increased risk of preterm birth. Paradoxically, much less is known about adverse maternal events. The combined risk of severe acute maternal morbidity in multiple pregnancies has not been documented previously in any nationwide prospective study. Objective: To assess the risk of severe acute maternal morbidity in multiple pregnancies in a high-income European country and identify possible risk indicators. Study design: In a population-based cohort study including all 98 hospitals with a maternity unit in the Netherlands, pregnant women with severe acute maternal morbidity were included in the period 1(st) August 2004 until 1(st) August 2006. We calculated the incidence of severe acute maternal morbidity in multiple pregnancies in the Netherlands using the Netherlands Perinatal Registry. Relative risks (RR) of severe acute maternal morbidity in multiple pregnancies compared to singletons were calculated. To identify possible risk indicators we also compared age, parity, method of conception, onset of labour and mode of delivery for multiple pregnancies using the Netherlands Perinatal Registry as reference. Results: 2552 cases of severe acute maternal morbidity were reported during the two-year study period. Among 202 multiple pregnancies (8.0%), there were 197 twins (7.8%) and five triplets (0.2%). The overall incidence of severe acute maternal morbidity was 7.0 per 1000 deliveries, 6.5 and 28.0 per 1000 for singletons and multiple pregnancies respectively. The relative risk of severe acute maternal morbidity compared to singleton pregnancies was 4.3 (95% confidence interval [95% CI] 3.7-5.0) and increased to 6.2 (95% CI 2.5-15.3) in triplet pregnancies. Risk indicators for developing severe acute maternal morbidity in women with multiple pregnancies were age of ≥40 (RR 2.5 95% CI 1.4-4.3), nulliparity (RR 1.8, 95% CI 1.4-2.4), use of assisted reproductive techniques (RR 1.9, 95% CI 1.4-2.5), and non-spontaneous onset of delivery (RR 1.6, 95% CI 1.2-2.1). No significant difference was found between mono- and dichorionic twins (RR 0.8, 95% CI 0.6-1.2). Conclusions: Women with multiple pregnancies in the Netherlands have a more than four times elevated risk of sustaining severe acute maternal morbidity as compared to singletons.
    American journal of obstetrics and gynecology 11/2015; DOI:10.1016/j.ajog.2015.11.003 · 4.70 Impact Factor
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    ABSTRACT: Introduction: This study was performed to assess the applicability of the WHO Maternal Near Miss tool (MNM-tool) and the organ dysfunction criteria in a high-income country. Material and methods: The MNM-tool was applied to 2552 women who died of pregnancy-related causes or sustained severe acute maternal morbidity between August 2004 and August 2006 in one of all 98 hospitals with a maternity unit in the Netherlands. Fourteen (0.6%) cases had insufficient data for application. Each case was assessed according to the three main 'MNM categories' specified in the MNM-tool and their subcategory criteria: five disease-, four intervention- and seven organ dysfunction-based criteria. Potentially life threatening conditions (disease-based inclusions) and life threatening cases (organ dysfunction-based inclusions) were differentiated according to WHO-methodology. Outcomes were incidence of all (sub)categories and case fatality rates. Results: Out of the 2538 cases, 2308 (90.9%) women fulfilled disease-based, 2116 (83.4%) intervention-based and 1024 (40.3%) the organ dysfunction-based criteria. Maternal death occurred in 48 women, of whom 23 (47.9%) fulfilled disease-based, 33 (68.8%) intervention-based and 31 (64.6%) organ dysfunction-based criteria. Case fatality rates was 33/2116 (1.6%) for cases fulfilling the disease-based criteria, 33/2116 (1.6%) for intervention-based criteria and 31/1024 (3.0%) for women fulfilling the organ dysfunction-based criteria. Conclusions: In the Netherlands, where advanced laboratory and clinical monitoring are available, organ dysfunction-based criteria of the MNM-tool failed to identify nearly two-thirds of sustained severe acute maternal morbidity cases and more than one-third of maternal deaths. Disease-based criteria remain important, and using only organ dysfunction-based criteria would lead to underestimating severe acute maternal morbidity. This article is protected by copyright. All rights reserved.
    Acta Obstetricia Et Gynecologica Scandinavica 10/2015; DOI:10.1111/aogs.12793 · 2.43 Impact Factor
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    ABSTRACT: Objective The aim of this study was to calculate preference weights for the Labor and Delivery Index (LADY-X) to make it suitable as a utility measure for perinatal care studies. Methods In an online discrete choice experiment, 18 pairs of hypothetical scenarios were presented to respondents, from which they had to choose a preferred option. The scenarios describe the birth experience in terms of the seven LADY-X attributes. A D-efficient discrete choice experiment design with priors based on a small sample (N = 110) was applied. Two samples were gathered, women who had recently given birth and subjects from the general population. Both samples were analyzed separately using a panel mixed logit (MMNL) model. Using the panel mixed multinomial logit (MMNL) model results and accounting for preference heterogeneity, we calculated the average preference weights for LADY-X attribute levels. These were transformed to represent a utility score between 0 and 1, with 0 representing the worst and 1 representing the best birth experience. Results In total, 1097 women who had recently given birth and 367 subjects from the general population participated. Greater value was placed on differences between bottom and middle attribute levels than on differences between middle and top levels. The attributes that resulted in larger utility increases than the other attributes were "feeling of safety" in the sample of women who had recently given birth and "feeling of safety" and "availability of professionals" in the general population sample. Conclusions By using the derived preference weights, LADY-X has the potential to be used as a utility measure for perinatal (cost-) effectiveness studies. © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR).
    Value in Health 09/2015; 18(6):856-864. DOI:10.1016/j.jval.2015.07.005 · 3.28 Impact Factor
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    Obstetric Anesthesia Digest 09/2015; 35(3):147. DOI:10.1097/01.aoa.0000469482.88094.d9
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    ABSTRACT: Background: Thyroid peroxidase antibodies (TPO-Ab) in euthyroid women are associated with recurrent miscarriage (RM) and other pregnancy complications such as preterm birth. It is unclear if treatment with levothyroxine improves pregnancy outcome. Aim To determine the effect of levothyroxine administration on live birth rate in euthyroid TPO-Ab positive women with recurrent miscarriage. Methods: /Design We will perform a multicenter, placebo controlled randomized trial in euthyroid women with recurrent miscarriage and TPO-Ab. Recurrent miscarriage is defined as two or more miscarriages before the 20th week of gestation. The primary outcome is live birth, defined as the birth of a living fetus beyond 24weeks of gestation. Secondary outcomes are ongoing pregnancy at 12weeks, miscarriage, preterm birth, (serious) adverse events, time to pregnancy and survival at 28days of neonatal life. The analysis will be performed according to the intention to treat principle. We need to randomize 240 women (120 per group) to demonstrate an improvement in live birth rate from 55% in the placebo group to 75% in the levothyroxine treatment group. This trial is a registered trial (NTR 3364, March 2012). Here we discuss the rationale and design of the T4-LIFE study, an international multi-center randomized, double blind placebo controlled, clinical trial aimed to assess the effectiveness of levothyroxine in women with recurrent miscarriage and TPO-Ab.
    Contemporary clinical trials 08/2015; 44. DOI:10.1016/j.cct.2015.08.005 · 1.94 Impact Factor
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    ABSTRACT: We recently reported that induction of labour does not improve short term neonatal outcome in women with late preterm premature rupture of membranes (PPROM) as compared to expectant management (PPROMEXIL trial). In this study the neurodevelopmental and behavioural outcome of the children from this trial at 2 years of age was studied. We studied outcome of offspring of women randomised in the PPROMEXIL study. These women had >24h of ruptured membranes and were between 34 and 37 weeks of pregnancy when they were randomised to induction of labour (IoL) or expectant management (EM). Two years after delivery, the parents received the ages and stages questionnaire (ASQ), the child behaviour checklist (CBCL) and a general questionnaire. Follow-up data were obtained from 234 children (121 after IoL, 113 after EM, response rate 59% (44% of the original 532 randomised women)). In the IoL group 16 children (14%) had an abnormal score in ≥1 domains of the ASQ, versus 27 (26%) in the EM group (difference in percentage -11.4 (95% CI -21.9 to -0.98; p=0.033)). For the CBCL, an abnormal score was found in 13% (n=15) in the IoL group and in 15% (n=16) in the EM group (difference in percentage -2.13 (95% CI -11.2 to 6.94; p=0.645)). Although a policy of induction of labour in women with late PPROM does not improve short term neonatal outcome, it might be associated with a decrease in neurodevelopmental difficulties at the age of two years as compared to expectant management. Expectant management did not lead to a difference in behavioural problems. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
    European journal of obstetrics, gynecology, and reproductive biology 08/2015; 194:17-23. DOI:10.1016/j.ejogrb.2015.07.014 · 1.70 Impact Factor
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    ABSTRACT: Objectives: To validate the Labor and Delivery Index (LADY-X), a new delivery-specific utility measure. Study design and setting: In a test-retest design, women were surveyed online, 6 to 8 weeks postpartum and again 1 to 2 weeks later. For reliability testing, we assessed the standard error of measurement (S.E.M.) and the intraclass correlation coefficient (ICC). For construct validity, we tested hypotheses on the association with comparison instruments (Mackey Childbirth Satisfaction Rating Scale and Wijma Delivery Experience Questionnaire), both on domain and total score levels. We assessed known-group differences using eight obstetrical indicators: method and place of birth, induction, transfer, control over pain medication, complications concerning mother and child, and experienced control. Results: The questionnaire was completed by 308 women, 257 (83%) completed the retest. The distribution of LADY-X scores was skewed. The reliability was good, as the ICC exceeded 0.80 and the S.E.M. was 0.76. Requirements for good construct validity were fulfilled: all hypotheses for convergent and divergent validity were confirmed, and six of eight hypotheses for known-group differences were confirmed as all differences were statistically significant (P-values: <0.001-0.023), but for two tests, difference scores did not exceed the S.E.M. Conclusion: The LADY-X demonstrates good reliability and construct validity. Despite its skewed distribution, the LADY-X can discriminate between groups. With the preference weights available, the LADY-X might fulfill the need for a utility measure for cost-effectiveness studies for perinatal care interventions.
    Journal of clinical epidemiology 07/2015; 68(10). DOI:10.1016/j.jclinepi.2015.05.020 · 3.42 Impact Factor
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    ABSTRACT: Preeclampsia is a pregnancy-specific syndrome characterized by renal dysfunction and high blood pressure. When evaluated with light microscopy, the renal lesion of preeclampsia is marked by endothelial cell swelling and the appearance of bloodless glomeruli. However, regarding the pathobiology of renal damage in preeclampsia, attention recently has shifted from the glomerular endothelial cells to the podocytes. The angiogenic imbalance in preeclampsia plays a key role in the development of both podocyte and endothelial damage in the glomerular filtration barrier. Here, we review the latest studies on the role of podocytes in the development of renal damage in preeclampsia and on podocytes as potential targets for diagnosis, treatment, and prevention of long-term complications of preeclampsia.
    Current Hypertension Reports 07/2015; 17(7):566. DOI:10.1007/s11906-015-0566-9 · 3.44 Impact Factor

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    ABSTRACT: To assess the effect of maintenance tocolysis in women who are at high or low risk for preterm delivery according to fetal fibronectin (fFN) status and cervical length (CL). We compared the risk of preterm delivery in fFN pos and fFN neg women and in women with a CL <15 mm and ≥15 mm, by using the Cox regression. Differences between the effectiveness of maintenance tocolysis in high- and low-risk women were assessed by using an interaction term. 122 fFN tests were taken, of which 50 were fFN pos. CL was measured in 236 women, of whom 52 women had a CL <15 mm. The median gestational age at delivery was lower in fFN pos women; fFN pos women had a higher hazard for preterm delivery at any point of time (HR 4.7; 95% CI 2.9 to 7.6). Comparable results were seen for CL. Neither fFN status nor CL did alter the effect of maintenance tocolysis, which was ineffective in the total randomized group, on the risk of preterm delivery (p for interaction = 0.87 for fFN and 0.18 for CL). Maintenance tocolytic therapy with nifedipine is ineffective and not dependent on fFN or CL status.
    The journal of maternal-fetal & neonatal medicine: the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians 06/2015; DOI:10.3109/14767058.2015.1053863 · 1.37 Impact Factor
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    ABSTRACT: To assess the impact of cervical length (CL) measurement and fetal fibronectin testing (fFN) on the clinicians' decision to prescribe antenatal corticosteroids (ACS) to women with symptoms of preterm labor. This is a secondary analysis of a prospective cohort study including women with symptoms of preterm labor and intact membranes between 24 and 34 weeks' gestation. We compared the proportion prescribed and completed ACS courses, preterm delivery within seven days and median intervals from ACS to delivery in four groups: group 1 CL<10mm, group 2 CL 10-30mm and positive fFN, group 3 CL 10-30mm and negative fFN, group 4 CL>30mm. ACS were prescribed to 63/65 (97%) women in group 1, 176/192 (91%) in group 2, 111/172 women (65%) in group 3 and 55/242 (23%) in group 4. In group 1, 42 (65%) women delivered within seven days, compared to 34 (18%) in group 2, 6 (3%) in group 3 and 3 (1%) in group 4. Median intervals between ACS and delivery were 6 days (IQR 3-61 days), 44 days (IQR 17-69 days), 53 days (IQR 37-77 days) and 66 days (IQR 43-78 days) in group 1, 2, 3 and 4 respectively. ACS were prescribed frequently to women with a CL of 10-30mm and a negative fFN test or a CL>30mm. There is room for improvement in the prescription of ACS in these low risk women. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
    European journal of obstetrics, gynecology, and reproductive biology 06/2015; 192. DOI:10.1016/j.ejogrb.2015.06.008 · 1.70 Impact Factor
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    ABSTRACT: To assess whether patient characteristics add to the fetal fibronectin test and cervical length measurement in the prediction of preterm delivery in symptomatic women. A nationwide prospective cohort study was conducted in all ten perinatal centres in the Netherlands. Women with symptoms of preterm labour between 24 and 34 weeks gestation with intact membranes were invited. In all women qualitative fibronectin testing (0.050μg/mL cut-off) and cervical length measurement were performed. Only singleton pregnancies were included in this analysis. Logistic regression was used to construct two multivariable models to predict spontaneously delivery within 7 days: a model including cervical length and fetal fibronectin as predictors, and an extended model including all potential predictors. The models were internally validated using bootstrapping techniques. Predictive performances were assessed as the area under the receiver operator characteristic curve (AUC) and calibration plots. We compared the models' capability to identify women with a low risk to deliver within 7 days. A risk less than 5%, corresponding to the risk for women with a cervical length of at least 25mm, was considered as low risk. Seventy-three of 600 included women (12%) had delivered spontaneously within 7 days. The extended model included maternal age, parity, previous preterm delivery, vaginal bleeding, C-reactive protein, cervical length, dilatation and fibronectin status. Both models had high discriminative performances (AUC of 0.92 (95% CI 0.88-0.95) and 0.95 (95% CI 0.92-0.97) respectively). Compared to the model with fibronectin and cervical length, our extended model reclassified 38 women (6%) from low risk to high risk and 21 women (4%) from high risk to low risk. Preterm delivery within 7 days occurred once in both the reclassification groups. In women with symptoms of preterm labour before 34 weeks gestation, a model that integrates maternal characteristics, clinical signs and laboratory tests, did not predict delivery within 7 days better than a model with only fibronectin and cervical length. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
    European journal of obstetrics, gynecology, and reproductive biology 06/2015; 192. DOI:10.1016/j.ejogrb.2015.05.004 · 1.70 Impact Factor
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    ABSTRACT: 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.
    AJP Reports 06/2015; 5(2). DOI:10.1055/s-0035-1552930
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    ABSTRACT: Results from a number of long-term follow-up studies have suggested that hypertensive disorders in pregnancy are associated with increased risk of cardiovascular disease later in life. More recently, this putative relationship has been substantiated with findings of elevated cardiovascular risk factors, such as lipid profiles and glucose, in women with a history of hypertensive pregnancy disorders. Homocysteine is a sensitive indicator of increased risk but data on homocysteine levels in women with a history of hypertensive pregnancy disorders are inconsistent. This cohort study included 279 women with a history of hypertensive pregnancy disorders at term and 85 women with a history of uncomplicated pregnancies who participated in the Hypitat Risk Assessment Study (HyRAS). Blood samples for total homocysteine determination were taken 2.5 years postpartum. Homocysteine levels were determined in plasma using an immunoassay. Women with a history of hypertensive pregnancy disorders had significant higher median homocysteine levels (10.66 μmol/L) 2.5 years postpartum compared with women with a history uncomplicated pregnancies (9.82 μmol/L; p=0.002). Women with a history of hypertensive pregnancy disorders had a higher risk of having a homocysteine level in the highest quartile (odds ratio 3.4, 95% confidence interval 1.5-7.6). At 2.5 years postpartum, women with a history hypertensive pregnancy disorders had higher homocysteine levels than women who had uncomplicated pregnancies. Although higher homocysteine levels might be a potential link between a history of hypertensive pregnancy disorders and increased cardiovascular disease risk later in life, the clinical implications remain an area for future research.
    Journal of Women's Health 06/2015; 24(6):524-529. DOI:10.1089/jwh.2015.5201 · 2.05 Impact Factor

  • Obstetric Anesthesia Digest 06/2015; 35(2):88-89. DOI:10.1097/01.aoa.0000463834.31552.e6
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    ABSTRACT: A growing body of evidence suggests that complement dysregulation plays a role in the pathogenesis of preeclampsia. The kidney is one of the major organs affected in preeclampsia. Because the kidney is highly susceptible to complement activation, we hypothesized that preeclampsia is associated with renal complement activation. We performed a nationwide search for renal autopsy material in the Netherlands using a computerized database (PALGA). Renal tissue was obtained from 11 women with preeclampsia, 25 pregnant controls, and 14 nonpregnant controls with hypertension. The samples were immunostained for C4d, C1q, mannose-binding lectin, properdin, C3d, C5b-9, IgA, IgG, and IgM. Preeclampsia was significantly associated with renal C4d-a stable marker of complement activation-and the classical pathway marker C1q. In addition, the prevalence of IgM was significantly higher in the kidneys of the preeclamptic women. No other complement markers studied differed between the groups. Our findings in human samples were validated using a soluble fms-like tyrosine kinase 1 mouse model of preeclampsia. The kidneys in the soluble fms-like tyrosine kinase 1-injected mice had significantly more C4 deposits than the control mice. The association between preeclampsia and renal C4d, C1q, and IgM levels suggests that the classical complement pathway is involved in the renal injury in preeclampsia. Moreover, our finding that soluble fms-like tyrosine kinase 1-injected mice develop excess C4 deposits indicates that angiogenic dysregulation may play a role in complement activation within the kidney. We suggest that inhibiting complement activation may be beneficial for preventing the renal manifestations of preeclampsia. © 2015 American Heart Association, Inc.
    Hypertension 05/2015; 66(1). DOI:10.1161/HYPERTENSIONAHA.115.05484 · 6.48 Impact Factor
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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; 32(12). DOI:10.1055/s-0035-1549396 · 1.91 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; 385(9986). DOI:10.1016/S0140-6736(14)61998-X · 45.22 Impact Factor

Publication Stats

3k Citations
1,143.03 Total Impact Points


  • 1995-2015
    • Leiden University Medical Centre
      • • Department of Obstetrics
      • • Department of Clinical Epidemiology
      Leyden, South Holland, Netherlands
  • 2014
    • University of Groningen
      Groningen, Groningen, Netherlands
  • 1995-2014
    • Leiden University
      • Molecular Cell Biology Group
      Leyden, South Holland, Netherlands
  • 2011
    • University Medical Center Utrecht
      • Julius Center for Health Sciences and Primary Care
      Utrecht, Utrecht, Netherlands
    • Radboud University Nijmegen
      • Department of Obstetrics and Gynecology
      Nymegen, Gelderland, Netherlands
    • Linköping University
      • Department of Clinical and Experimental Medicine (IKE)
      Linköping, Östergötland, Sweden
    • University of Adelaide
      • Robinson Institute
      Tarndarnya, South Australia, Australia
    • Albert Schweitzer Ziekenhuis
      Dordt, South Holland, Netherlands
  • 1999
    • University of Amsterdam
      Amsterdamo, North Holland, Netherlands