37 research outputs found

    The predictive capacity of uterine artery Doppler for preterm birth - a cohort study

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    Introduction: Mid‐trimester uterine artery resistance measured with Doppler sonography is predictive for iatrogenic preterm birth. In view of the emerging association between hypertensive disease in pregnancy and spontaneous preterm birth, we hypothesized that uterine artery resistance could also predict spontaneous preterm birth. Material and methods: We performed a cohort study of women with singleton pregnancies. Uterine artery resistance was routinely measured at the 18‐22 weeks anomaly scan. Pregnancies complicated by congenital anomalies or intrauterine fetal death were excluded. We analyzed if the waveform of the uterine artery (no notch, unilateral notch or bilateral notch) was predictive for spontaneous and iatrogenic preterm birth, defined as delivery before 37 weeks of gestation. Furthermore, we assessed whether the uterine artery pulsatility index was associated with the risk of preterm birth. Results: Between January 2009 and December 2016 we collected uterine Doppler indices and relevant outcome data in 4521 women. Mean gestational age at measurement was 19+6 weeks. There were 137 (3.0%) women with a bilateral and 213 (4.7%) with a unilateral notch. Mean gestational age at birth was 38+6 weeks. Spontaneous and iatrogenic preterm birth rates were 5.7% and 4.9%, respectively. Mean uterine artery resistance was 1.12 in the spontaneous preterm birth group compared with 1.04 in the term group (P = 0.004). The risk of preterm birth was increased with high uterine artery resistance (OR 2.9 per unit; 95% CI 2.4‐3.9). Prevalence of spontaneous preterm birth increased from 5.5% in women without a notch in the uterine arteries to 8.0% in women with a unilateral notch and 8.0% in women with a bilateral notch. For iatrogenic preterm birth, these rates were 3.9%, 13.6% and 23.4%, respectively. Likelihood ratios for the prediction of spontaneous preterm birth were 1.6 (95% CI 1.0‐2.6) and 1.9 (95% CI 1.0‐3.5) for unilateral and bilateral notches, respectively, and for iatrogenic preterm birth they were 3.6 (95% CI 2.5‐5.2) and 6.8 (95% CI 4.7‐9.9) for unilateral and bilateral notches, respectively. Of all women with bilateral notching, 31.4% delivered preterm. Conclusions: Mid‐trimester uterine artery resistance measured at 18‐22 weeks of gestation is a weak predictor of spontaneous preterm birth.Maud D. van Zijl, Bouchra Koullali, Ben W.J. Mol, Rosalinde J. Snijders, Brenda M. Kazemier, Eva Pajkr

    Care after pancreatic resection according to an algorithm for early detection and minimally invasive management of pancreatic fistula versus current practice (PORSCH-trial): design and rationale of a nationwide stepped-wedge cluster-randomized trial

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    BACKGROUND: Pancreatic resection is a major abdominal operation with 50% risk of postoperative complications. A common complication is pancreatic fistula, which may have severe clinical consequences such as postoperative bleeding, organ failure and death. The objective of this study is to investigate whether implementation of an algorithm for early detection and minimally invasive management of pancreatic fistula may improve outcomes after pancreatic resection. METHODS: This is a nationwide stepped-wedge, cluster-randomized, superiority trial, designed in adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. During a period of 22 months, all Dutch centers performing pancreatic surgery will cross over in a randomized order from current practice to best practice according to the algorithm. This evidence-based and consensus-based algorithm will provide da

    Colorectal liver metastases: Surgery versus thermal ablation (COLLISION) - a phase III single-blind prospective randomized controlled trial

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    Background: Radiofrequency ablation (RFA) and microwave ablation (MWA) are widely accepted techniques to eliminate small unresectable colorectal liver metastases (CRLM). Although previous studies labelled thermal ablation inferior to surgical resection, the apparent selection bias when comparing patients with unresectable disease to surgical candidates, the superior safety profile, and the competitive overall survival results for the more recent reports mandate the setup of a randomized controlled trial. The objective of the COLLISION trial is to prove non-inferiority of thermal ablation compared to hepatic resection in patients with at least one resectable and ablatable CRLM and no extrahepatic disease. Methods: In this two-arm, single-blind multi-center phase-III clinical trial, six hundred and eighteen patients with at least one CRLM (≤3cm) will be included to undergo either surgical resection or thermal ablation of appointed target lesion(s) (≤3cm). Primary endpoint is OS (overall survival, intention-to-treat analysis). Main secondary endpoints are overall disease-free survival (DFS), time to progression (TTP), time to local progression (TTLP), primary and assisted technique efficacy (PTE, ATE), procedural morbidity and mortality, length of hospital stay, assessment of pain and quality of life (QoL), cost-effectiveness ratio (ICER) and quality-adjusted life years (QALY). Discussion: If thermal ablation proves to be non-inferior in treating lesions ≤3cm, a switch in treatment-method may lead to a reduction of the post-procedural morbidity and mortality, length of hospital stay and incremental costs without compromising oncological outcome for patients with CRLM. Trial registration:NCT03088150 , January 11th 2017

    Improving perinatal outcome: towards individualized care

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    Unfortunately not all pregnancies and deliveries take place without complications. Complications during pregnancy or delivery can lead to maternal morbidity and poor perinatal outcomes such as perinatal mortality or (severe) neonatal morbidity. First assessment in antenatal care is to distinguish women who require standard care from those requiring special attention. At the moment, we can make some global risk assessments, but are not able to give a women a risk assessment that is adapted for her. For instance, foetal characteristics and pregnancy specific/environmental factors are often not incorporated in the risk assessment these days, even though they play a role. If we can predict more precisely who is at risk (for preterm birth or any other pregnancy complication) preventive strategies can be used to decrease complications and improving poor perinatal outcomes. Obviously many different factors are related to poor perinatal outcomes. The objective of this thesis was to identify women at risk in order to improve perinatal outcomes. We focused on three subjects with separate aims: - study screening options for spontaneous preterm birth at different time points during pregnancy in order to identify risk factors and gain insight in pathophysiologic mechanisms; - investigate the association between asymptomatic bacteriuria and poor perinatal and maternal outcome to investigate the necessity of a screen and treat program in the Netherlands; - explore differences in perinatal mortality near term in certain subgroups in order to individualize management of these pregnancies

    Trends in preterm birth in singleton and multiple gestations in the Netherlands 2008-2015: a population-based study

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    Objective: Preterm birth is the most important cause of perinatal morbidity and mortality. Over the past years several preventive measures have been studied and implemented. Preterm birth percentage in 2015 in the Netherlands was 6.9 %, according to data from the European Peristat project, reporting on perinatal health in Europe. Various preventive measures might have influenced the incidence and outcome of preterm birth. Our aim was to give an overview of the trends in preterm births for both singleton and multiple gestations in the Netherlands in order to guide future research. Study Design: We studied a nationwide cohort including both singleton and multiple gestations without congenital anomalies between 2008 and 2015. Outcomes were total preterm birth (defined as birth before 37 weeks of gestation), spontaneous and iatrogenic preterm birth < 37 weeks, spontaneous and iatrogenic preterm birth percentages between 34-36 weeks, 32-34 weeks, 28-31 weeks and ≤ 27 weeks using a moving average technique. Trend analysis was performed using the Cochran Armitage test. Singleton and multiple gestations were analyzed separately. Results: Our final study population comprised 1,303.786 women with a singleton and 44,951 women with a multiple pregnancy. Preterm birth < 37 weeks in singletons decreased from 5.6 % in 2008 to 5.3 % in 2015 (P < 0.0001), in both spontaneous and iatrogenic preterm birth. Preterm birth ≤ 27 weeks increased from 0.40 % to 0.45 % (P for trend <0.0001). The number of multiple gestations decreased over the years, as well as the percentage of multiples conceived through IVF/ICSI. There was an increase in total and iatrogenic preterm birth < 37 weeks from 36.7-38.2% (P < 0.0001) in multiples. The number of multiples <32 decreased, in both the spontaneous and iatrogenic group. Conclusion: In the Netherlands preterm birth risk in singletons decreased between 2008 and 2015 but an increase was noted in preterm birth ≤ 27 weeks. In multiples the total preterm birth risk increased, due to an increase in indicated preterm birth.Maud D. van Zijl, Bouchra Koullali, Martijn A. Oudijk, Anita C.J. Ravelli, Ben W.J. Mol, Eva Pajkrt, Brenda M. Kazemie

    Recurrence rate and outcome of postterm pregnancy, a national cohort study

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    Contains fulltext : 153825.pdf (publisher's version ) (Closed access)OBJECTIVE: To assess the recurrence rate of postterm delivery (gestational age at or beyond 42+0 weeks or 294 days) and to describe maternal and perinatal outcomes after previous postterm delivery. STUDY DESIGN: From the longitudinal linked Netherlands Perinatal Registry database, we selected all singleton primiparous women who delivered between 37+0 and 42+6 weeks with a subsequent singleton pregnancy from 1999 to 2007. We excluded congenital abnormalities. We compared the recurrence rate of postterm delivery and risk of antenatal fetal death in women with and without a postterm delivery in their first pregnancy. We compared perinatal outcome (composite of perinatal mortality, Apgar score 1000ml and blood transfusions) between women with a recurrent and a de novo postterm second pregnancy. RESULTS: Our study population consisted of 233,327 women of whom 17,874 (7.7%) delivered postterm in the first pregnancy. In the second pregnancy, 2678 (15%) women had a recurrent postterm delivery compared to 8698 (4%) women with a de novo postterm delivery (odds ratio (OR) 4.2 95% confidence interval (CI) 4.0-4.4). Subgroup analysis in recurrent and de novo postterm delivery showed no differences in composite perinatal and composite maternal outcome (OR 1.0; CI 0.7-1.5, p=0.90 and OR 1.1, CI 0.9-1.4, p=0.16), adjusted for fetal position and mode of delivery). CONCLUSIONS: Women with a postterm delivery in the first pregnancy have a higher risk of recurrent postterm delivery. Our data suggest that there is no difference in the composite adverse perinatal outcome between recurrent and de novo postterm delivery
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