Summary 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<0·0001). No cases of maternal or neonatal death or eclampsia were recorded. Interpretation Induction of labour is associated with improved maternal outcome and should be advised for women with mild hypertensive disease beyond 37 weeks' gestation. Funding ZonMw.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Objective The purpose of this study was to determine cardiovascular risk factors in women with a history of hypertensive pregnancy disorders at term (HTP) 2.5 years after pregnancy. Study Design In a ...multicenter cohort study in The Netherlands from June 2008 through November 2010, cardiovascular risk factors were compared between women with a history of HTP (HTP cohort, n = 306) and women with a history of normotensive pregnancies at term (NTP cohort, n = 99). HTP women had participated in a randomized, longitudinal trial assessing the effectiveness of induction of labor in women with hypertensive pregnancy disorders at term. All women were assessed 2.5 years after pregnancy for blood pressure, anthropometrics, glucose, glycosylated hemoglobin, insulin, homeostatic model assessment score, total cholesterol, high-density lipoprotein cholesterol, triglycerides, high-sensitivity C-reactive protein, and microalbumin and metabolic syndrome. Results After a mean follow-up period of 2.5 years, hypertension (HTP, 34%; NTP, 1%; P < .001) and metabolic syndrome (HTP, 25%; NTP, 5%; P < .001) were more prevalent in HTP women compared with NTP women. HTP women had significantly higher systolic and diastolic blood pressure, higher body mass index, and higher waist circumference. Glucose, glycosylated hemoglobin, insulin, homeostatic model assessment score, total cholesterol, triglycerides, and high-sensitivity C-reactive protein levels were significantly higher and high-density lipoprotein cholesterol was significantly lower in HTP women. Conclusion In women with a history of HTP, hypertension and metabolic syndrome are more common, and they have higher levels of biochemical cardiovascular risk factors 2.5 years after pregnancy.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Objective The aim of this study was to investigate which nonclassic cardiovascular biomarkers are associated with persistent endothelial dysfunction after pregnancy in women with a history of ...hypertensive pregnancy disorders compared with women with uncomplicated pregnancies. Study Design This was a systematic review and metaanalysis of observational studies. A search was performed in PubMed, Embase, Cochrane, and Cinahl including articles from inception to Feb. 27, 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 nonclassic cardiovascular biomarkers are described in this review; 12 studies on 5 biomarkers were included in the metaanalysis. Results Women with a history of hypertensive pregnancy disorders had a higher homocysteine level compared with women with a history of uncomplicated pregnancies (5 studies; pooled mean difference, 0.77 ng/mL; 95% confidence interval, 0.27–1.26; P < .01). For the other nonclassic cardiovascular biomarkers including markers in areas of inflammation, thrombosis, and angiogenesis, we found no significant differences. Conclusion This review and metaanalysis showed that women with a history of hypertensive pregnancy disorders have higher homocysteine levels compared with women with a history of uncomplicated pregnancies. These data suggest persistent endothelial alteration after pregnancies complicated by hypertensive disorders.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Abstract Use of quality indicators by obstetric caregivers in the Netherlands: a descriptive study. Objective To evaluate the use of quality indicators by obstetric caregivers in hospitals in the ...Netherlands. Study design: An anonymous, self-administered survey was conducted in a convenience sample of obstetricians and clinical midwives in Dutch hospitals. Descriptive statistics were used to analyse the data, both for all caregivers and stratified by hospital setting and profession (obstetricians and midwives). Differences between strata were tested at a 5% significance level. Results The response rate to the online questionnaire was 61% (n = 171/279). Of all respondents 83% were aware of the quality indicators and 63% contributed to their registration. Caregivers received information about the indicators by mail or in meetings according to 64% (internal indicators) and 48% (external indicators) of the respondents. Of the respondents 56% (internal indicators) and 41% (external indicators) stated to use the results of indicators when designing plans to improve the quality of care. Conclusion We conclude that obstetric quality indicators are not widely used by obstetricians and midwives in Dutch hospitals to improve quality of care. To improve quality of care and the effective use of quality indicators we suggest to focus first on registering outcome indicators. These indicators should be implemented in quality structures that ensure that action is taken.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
Background Twin pregnancies are at increased risk for perinatal morbidity and death because of many factors that include a high incidence of preterm delivery. Compared with singleton pregnancies, ...overall perinatal risk of death is higher in twin pregnancies; however, for the preterm period, the perinatal mortality rate has been reported to be lower in twins. Objective The purpose of this study was to compare perinatal mortality rates in relation to gestational age at birth between singleton and twin pregnancies, taking into account socioeconomic status, fetal sex, and parity. Study Design We studied perinatal mortality rates according to gestational age at birth in 1,502,120 singletons pregnancies and 51,658 twin pregnancies without congenital malformations who were delivered between 2002 and 2010 after 28 weeks of gestation. Data were collected from the nationwide Netherlands Perinatal Registry. Results Overall the perinatal mortality rate in twin pregnancies (6.6/1000 infants) was higher than in singleton pregnancies (4.1/1000 infants). However, in the preterm period, the perinatal mortality rate in twin pregnancies was substantially lower than in singleton pregnancies (10.4 per 1000 infants as compared with 34.5 per 1000 infants, respectively) for infants who were born at <37 weeks of gestation; this held especially for antepartum deaths. After 39 weeks of gestation, the perinatal mortality rate was higher in twin pregnancies. Differences in parity, fetal sex, and socioeconomic status did not explain the observed differences in outcome. Conclusion Overall the perinatal mortality rate was higher in twin pregnancies than in singleton pregnancies, which is most likely caused by the high preterm birth rate in twins and not by a higher mortality rate for gestation, apart from term pregnancies. During the preterm period, the antepartum mortality rate was much lower in twin pregnancies than in singleton pregnancies. We suggest that this might be partially due to a closer monitoring of twin pregnancies, which indirectly suggests a need for closer surveillance of singleton pregnancies.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Abstract Objective Preterm birth is the most common cause of neonatal morbidity and mortality. Around one third of preterm deliveries starts with preterm prelabor rupture of membranes (PPROM). The ...aim of this trial was to study the effect of prolonged tocolysis with nifedipine versus placebo in women with PPROM on perinatal outcome and prolongation of pregnancy. Study design The Apostel IV was a nationwide multicenter randomized placebo controlled trial. We included women with PPROM without contractions between 24 + 0 and 33 + 6 weeks of gestation. Participants were randomly allocated to daily 80 mg nifedipine or placebo, until the start of labor, with a maximum of 18 days. The primary outcome measure was a composite of poor neonatal outcome, including perinatal death, bronchopulmonary dysplasia, periventricular leukomalacia > grade 1, intraventricular hemorrhage > grade 2, necrotizing enterocolitis > stage 1 and culture proven sepsis. Secondary outcomes were gestational age at delivery and prolongation of pregnancy. Analysis was by intention to treat. To detect a reduction of poor neonatal outcome from 30% to 10%, 120 women needed to be randomized. Trial registry: NTR 3363. Results Between October 2012 and December 2014 we randomized 25 women to nifedipine and 25 women to placebo. Due to slow recruitment the study was stopped prematurely. The median gestational age at randomization was 29.9 weeks (IQR 27.7-31.3) in the nifedipine group and 27.0 weeks (IQR 24.7-29.9) in the placebo group. Other baseline characteristics were comparable. The adverse perinatal outcome occurred in 9 neonates (33.3%) in the nifedipine group and 9 neonates (32.1%) in the placebo group (RR 1.04, 95% CI 0.49-2.2). Two perinatal deaths occurred, both in the nifedipine group. Bronchopulmonary dysplasia was seen less frequently in the nifedipine group (0% vs. 17.9%; p = 0.03). Prolongation of pregnancy did not differ between the nifedipine and placebo group (median 11 vs. 8 days, HR 1.02; 95% CI 0.58-1.79). Conclusion This randomized trial did not show a beneficial effect of prolonged tocolysis on neonatal outcomes or prolongation of pregnancy in women with PPROM without contractions. However, since results are based on a small sample size, a difference in effectiveness cannot be excluded.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
BACKGROUND: Severe maternal morbidity has been shown to have specific, long-term effects on health and wellbeing, such as daily functioning and mental health. OBJECTIVE: This study aimed to ...multidimensionally assess the long-term impact of maternal near-miss complications in Zanzibar. STUDY DESIGN: A prospective cohort study was conducted in Zanzibar's referral hospital. Women with maternal near-miss complications were matched with controls. At 3, 6, and 12 months after hospital discharge, history was taken, blood pressure and haemoglobin levels were measured, and multiple validated questionnaires (WHOQOL-BREF, WHODAS2.0, Patient Health Questionnaire-9, Harvard Trauma Questionnaire-16) were administered assessing experienced quality of life and disability, and screening for depression and posttraumatic stress disorder. RESULTS: We included 223 women after maternal near-miss complications and 213 women controls. There was a high prevalence of hypertension at 6 and 12 months in both groups and significantly higher after a near-miss. The proportion of women with low quality of life, disability, depression, or posttraumatic stress disorder was not significantly different between the 2 groups. A poor outcome for at least 1 of these 3 health domains was more prevalent after a near-miss complication. CONCLUSION: In Zanzibar, women after maternal near-miss complications report similar but slower recovery to control participants in the assessed dimensions. Adaptation of perceptions on and coping mechanisms with daily reality might partly explain this. Hypertension has a high prevalence after childbirth and should be treated adequately to prevent recurrent obstetrical and cardiovascular complications. Blood pressure follow-up for all women who delivered at Mnazi Mmoja Hospital seemed justified.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Summary Background In women with threatened preterm birth, delay of delivery by 48 h allows antenatal corticosteroids to improve neonatal outcomes. For this reason, tocolytics are often administered ...for 48 h; however, there is no consensus about which drug results in the best maternal and neonatal outcomes. In the APOSTEL III trial we aimed to compare the effectiveness and safety of the calcium-channel blocker nifedipine and the oxytocin inhibitor atosiban in women with threatened preterm birth. Methods We did this multicentre, randomised controlled trial in ten tertiary and nine teaching hospitals in the Netherlands and Belgium. Women with threatened preterm birth (gestational age 25–34 weeks) were randomly assigned (1:1) to either oral nifedipine or intravenous atosiban for 48 h. An independent data manager used a web-based computerised programme to randomly assign women in permuted block sizes of four, with groups stratified by centre. Clinicians, outcome assessors, and women were not masked to treatment group. The primary outcome was a composite of adverse perinatal outcomes, which included perinatal mortality, bronchopulmonary dysplasia, sepsis, intraventricular haemorrhage, periventricular leukomalacia, and necrotising enterocolitis. Analysis was done in all women and babies with follow-up data. The study is registered at the Dutch Clinical Trial Registry, number NTR2947. Findings Between July 6, 2011, and July 7, 2014, we randomly assigned 254 women to nifedipine and 256 to atosiban. Primary outcome data were available for 248 women and 297 babies in the nifedipine group and 255 women and 294 babies in the atosiban group. The primary outcome occurred in 42 babies (14%) in the nifedipine group and in 45 (15%) in the atosiban group (relative risk RR 0·91, 95% CI 0·61–1·37). 16 (5%) babies died in the nifedipine group and seven (2%) died in the atosiban group (RR 2·20, 95% CI 0·91–5·33); all deaths were deemed unlikely to be related to the study drug. Maternal adverse events did not differ between groups. Interpretation In women with threatened preterm birth, 48 h of tocolysis with nifedipine or atosiban results in similar perinatal outcomes. Future clinical research should focus on large placebo-controlled trials, powered for perinatal outcomes. Funding ZonMw (the Netherlands Organisation for Health Research and Development).
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP