ORCID Profile
0000-0002-7243-2115
Current Organisations
Amsterdam UMC
,
Amsterdam Reproduction and Development Research Institute
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Publisher: Wiley
Date: 10-2018
DOI: 10.1002/UOG.19191
Publisher: Informa UK Limited
Date: 06-01-2014
DOI: 10.3109/10641955.2013.872253
Abstract: To validate a previously published prediction model for recurrent early-onset preecl sia (PE). We included 229 pregnant women with a history of early-onset PE and computed their risk using the prediction model, compared the predicted risk to their pregnancy outcomes and assessed performance of the model. Early-onset PE recurred in 6.6% of participants. The area under the receiver operating characteristic curve was 59% (95% CI: 45-73). The model created groups that were only moderately different in terms of their risk. The model's discriminate ability was poor and predictive performance insufficient to classify women into relevant risk groups.
Publisher: Elsevier BV
Date: 03-2017
DOI: 10.1016/J.AJOG.2017.01.014
Abstract: Preecl sia and small-for-gestational-age pregnancy are major causes of maternal and perinatal morbidity and mortality. Women with a previous pregnancy affected by these conditions are at an increased risk of recurrence in a future pregnancy. Past trials evaluating the effect of low-molecular-weight heparin for the prevention of recurrence of preecl sia and small-for-gestational-age pregnancy have shown conflicting results with high levels of heterogeneity displayed when trials were compared. We sought to assess the effectiveness of enoxaparin in addition to high-risk care for the prevention of preecl sia and small-for-gestational-age pregnancy in women with a history of these conditions. This was an open-label randomized controlled trial in 5 tertiary care centers in 3 countries. Women with a viable singleton pregnancy were invited to participate between >6 Between July 26, 2010, and Oct. 28, 2015, a total of 156 participants were enrolled and included in the analysis. In all, 149 participants were included in the outcome analysis (72 receiving standard high-risk care plus enoxaparin and 77 receiving standard high-risk care only). Seven women who miscarried <16 weeks' gestation were excluded. The majority of participants (151/156, 97%) received aspirin. The addition of enoxaparin had no effect on the rate of preecl sia and/or small-for-gestational-age <5th customized birthweight percentile: enoxaparin 18/72 (25%) vs no enoxaparin 17/77 (22.1%) (odds ratio, 1.19 95% confidence interval, 0.53-2.64). There was also no difference in any of the secondary outcome measures. Levels of soluble fms-like tyrosine kinase-1 and soluble endoglin increased among those who developed preecl sia, but there was no difference in levels of these antiangiogenic factors (nor any of the other serum analytes measured) among those treated with enoxaparin compared to those receiving standard high-risk care only. The use of enoxaparin in addition to standard high-risk care does not reduce the risk of recurrence of preecl sia and small-for-gestational-age infants in a subsequent pregnancy.
Publisher: Wiley
Date: 07-04-2016
DOI: 10.1111/AOGS.12877
Publisher: Elsevier BV
Date: 08-2019
DOI: 10.1016/J.AJOG.2019.03.024
Abstract: Management of preterm hypertensive disorders remains a clinical dilemma. The maternal benefits of delivery need to be weighed against the adverse neonatal consequences of preterm birth. Long-term consequences of obstetric management in offspring of women with hypertensive disorders in preterm pregnancy are largely unknown. We report child neurodevelopmental and behavioral outcomes at 2 years after the Hypertension and Preecl sia Intervention Trial at near Term (HYPITAT-II) trial, which compared immediate delivery versus expectant monitoring in mild late preterm hypertensive disorders of pregnancy. To compare effects of immediate delivery vs expectant monitoring on neurodevelopmental and behavioral outcomes at 2 years of age in offspring of women with mild late preterm hypertensive disorders. We studied children born in the HYPITAT-II trial, a study in which women (n = 704) with hypertensive disorders of pregnancy who were between 34 and 37 weeks' gestation were randomized to immediate delivery or expectant monitoring. Participating women were asked to complete the Ages and Stages Questionnaire for developmental outcome and the Child Behavior Checklist for behavioral problems when their toddlers were 2 years old. We approached 545 of 704 randomized women (77%) 330 of 545 (61%) returned the questionnaires. In the immediate delivery group, 45 of 162 infants (28%) had an abnormal Ages and Stages Questionnaire score compared to 27 of 148 (18%) in the expectant monitoring group (risk difference, 9.6% 95% CI, 0.3-18.0%) P = .045. In the pregnancies (n = 94) that delivered before reaching 36 weeks, 27% (n = 25) had an abnormal Ages and Stages Questionnaire score compared to 22% (n = 47) when delivered after 36 weeks (odds ratio, 0.77 confidence interval, 0.44-1.34). An abnormal Child Behavior Checklist outcome was found in 31 of 175 (18%) in the delivery group vs 24 of 166 (15%) in the expectant monitoring group (risk difference, 3.2% 95% CI, -4.6% to 11.0%). After correction for maternal education, management strategy remained an independent predictor of abnormal Ages and Stages Questionnaire score (odds ratio, 0.48 confidence interval, 0.24 to -0.96, P = .03). In multivariable analyses, low birth weight, low maternal education, and immediate delivery policy were all significantly associated with an abnormal Ages and Stages Questionnaire score. In this study, we found that early delivery in women with late preterm hypertensive disorders is associated with poorer neurodevelopmental outcomes in their children at 2 years of age. These findings indicate an increased risk of developmental delay after early delivery compared to expectant monitoring. This follow-up study underlines the conclusion of the original HYPITAT-II study that, until the clinical situation deteriorates, expectant monitoring remains the most appropriate management strategy in the light of short- and long-term neonatal outcomes in women with preterm hypertensive disorders.
Publisher: Elsevier BV
Date: 10-2019
DOI: 10.1016/J.PREGHY.2019.08.166
Abstract: The international CHIPS Trial (Control of Hypertension In Pregnancy Study) enrolled 987 women with chronic (75%) or gestational (25%) hypertension. Pre-ecl sia developed in 48% women remained on their allocated BP control and delivered an average of two weeks later. 'Less tight' control (target diastolic BP 100 mmHg) achieved BP that was 6/5mmHg higher (p < 0.001) than 'tight' control (target diastolic 85 mmHg, BP achieved 133/85 mmHg). 'Less tight' (vs. 'tight') control resulted in similar adverse perinatal outcomes (31.5% vs. 30.7% p = 0.84) that balanced birthweight < 10th percentile (16.1% vs. 19.8% p = 0.14) against preterm birth (35.6% vs. 31.5% p = 0.18). 12-month follow-up revealed no compelling evidence for developmental programming of child growth. However, 'less tight' (vs. 'tight') control resulted in more severe maternal hypertension (40.6% vs. 27.5% p < 0.001), and more women with platelets < 100 × 10
Publisher: Wiley
Date: 11-03-2023
DOI: 10.1002/UOG.26160
Abstract: Birth weight, fetal growth and placental function influence cognitive development. The gradient of these associations is understudied, especially among those with a birth weight considered appropriate‐for‐gestational age. The aim of this study was to evaluate the associations between birth‐weight centile and intellectual development in term/near‐term infants across the entire birth‐weight spectrum, in order to provide a basis for better understanding of the long‐term implications of fetal growth restriction and reduced placental function. This was a population‐based cohort study of 266 440 liveborn singletons from uncomplicated pregnancies, delivered between 36 and 42 weeks of gestation. Perinatal data were obtained from the Dutch Perinatal Registry over the period 2003–2008 and educational data for children aged approximately 12 years were obtained from Statistics Netherlands over the period 2016–2019. Regression analyses were conducted to assess the association of birth‐weight centile with school performance. The primary outcomes were mean school performance score, on a scale of 501–550, and proportion of children who reached higher secondary school level. Mean school performance score increased gradually with increasing birth‐weight centile, from 533.6 in the 1 st –5 th birth‐weight‐centile group to 536.8 in the 81 st –85 th birth‐weight‐centile group. Likewise, the proportion of children at higher secondary school level increased with birth‐weight centile, from 43% to 57%. Compared with the 81 st –85 th birth‐weight‐centile group, mean school performance score and proportion of children at higher secondary school level were significantly lower in all birth‐weight‐centile groups below the 80 th centile, after adjusting for confounding factors. Birth‐weight centile is associated positively with school performance at 12 years of age across the entire birth‐weight spectrum, well beyond the conventional and arbitrary cut‐offs for suspected fetal growth restriction. This underlines the importance of developing better tools to diagnose fetal growth restriction and reduced placental function, and to identify those at risk for associated short‐ and long‐term consequences. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 11-2016
DOI: 10.1161/HYPERTENSIONAHA.116.07862
Abstract: To determine whether clinical outcomes differed by occurrence of severe hypertension in the international CHIPS trial (Control of Hypertension in Pregnancy Study), adjusting for the interventions of “less tight” (target diastolic blood pressure [dBP] 100 mm Hg) versus “tight” control (target dBP 85 mm Hg). In this post-hoc analysis of CHIPS data from 987 women with nonsevere nonproteinuric preexisting or gestational hypertension, mixed effects logistic regression was used to compare the following outcomes according to occurrence of severe hypertension, adjusting for allocated group and the influence of baseline factors: CHIPS primary (perinatal loss or high-level neonatal care for hours) and secondary outcomes (serious maternal complications), birth weight th percentile, preecl sia, delivery at or weeks, platelets ×10 9 /L, elevated liver enzymes with symptoms, maternal length of stay ≥10 days, and maternal readmission before 6 weeks postpartum. Three hundred and thirty-four (34.1%) women in CHIPS developed severe hypertension that was associated with all outcomes examined except for maternal readmission ( P =0.20): CHIPS primary outcome, birth weight th percentile, preecl sia, preterm delivery, elevated liver enzymes (all P .001), platelets ×10 9 /L ( P =0.006), and prolonged hospital stay ( P =0.03). The association between severe hypertension and serious maternal complications was seen only in less tight control ( P =0.02). Adjustment for preecl sia (464, 47.3%) did not negate the relationship between severe hypertension and the CHIPS primary outcome ( P .001), birth weight th percentile ( P =0.005), delivery at ( P .001) or weeks ( P .001), or elevated liver enzymes with symptoms ( P =0.02). Severe hypertension is a risk marker for adverse maternal and perinatal outcomes, independent of BP control or preecl sia co-occurrence. URL: pre-empt.cfri.ca/ . Unique identifier: ISRCTN 71416914. URL: www.clinicaltrials.gov/ . Unique identifier: NCT01192412.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 10-2016
DOI: 10.1161/HYPERTENSIONAHA.116.07466
Abstract: The CHIPS randomized controlled trial (Control of Hypertension in Pregnancy Study) found no difference in the primary perinatal or secondary maternal outcomes between planned “less tight” (target diastolic 100 mm Hg) and “tight” (target diastolic 85 mm Hg) blood pressure management strategies among women with chronic or gestational hypertension. This study examined which of these management strategies is more or less costly from a third-party payer perspective. A total of 981 women with singleton pregnancies and nonsevere, nonproteinuric chronic or gestational hypertension were randomized at 14 to 33 weeks to less tight or tight control. Resources used were collected from 94 centers in 15 countries and costed as if the trial took place in each of 3 Canadian provinces as a cost-sensitivity analysis. Eleven hospital ward and 24 health service costs were obtained from a similar trial and provincial government health insurance schedules of medical benefits. The mean total cost per woman–infant dyad was higher in less tight versus tight control, but the difference in mean total cost (DM) was not statistically significant in any province: Ontario ($30 191.62 versus $24 469.06 DM $5723, 95% confidence interval, −$296 to $12 272 P =0.0725) British Columbia ($30 593.69 versus $24 776.51 DM $5817 95% confidence interval, −$385 to $12 349 P =0.0725) or Alberta ($31 510.72 versus $25 510.49 DM $6000.23 95% confidence interval, −$154 to $12 781 P =0.0637). Tight control may benefit women without increasing risk to neonates (as shown in the main CHIPS trial), without additional (and possibly lower) cost to the healthcare system. URL: www.clinicaltrials.gov . Unique identifier: NCT01192412.
Publisher: Wiley
Date: 30-08-2019
DOI: 10.1111/AOGS.13709
Publisher: Wiley
Date: 20-07-2020
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 05-2015
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-2018
DOI: 10.1161/HYPERTENSIONAHA.117.10689
Abstract: For hypertensive women in CHIPS (Control of Hypertension in Pregnancy Study), we assessed whether the maternal benefits of tight control could be achieved, while minimizing any potentially negative effect on fetal growth, by delaying initiation of antihypertensive therapy until later in pregnancy. For the 981 women with nonsevere, chronic or gestational hypertension randomized to less-tight (target diastolic blood pressure, 100 mm Hg), or tight (target, 85 mm Hg) control, we used mixed-effects logistic regression to examine whether the effect of less-tight (versus tight) control on major outcomes was dependent on gestational age at randomization, adjusting for baseline factors as in the primary analysis and including an interaction term between gestational age at randomization and treatment allocation. Gestational age was considered categorically (quartiles) and continuously (linear or quadratic form), and the optimal functional form selected to provide the best fit to the data based on the Akaike information criterion. Randomization before (but not after) 24 weeks to less-tight (versus tight) control was associated with fewer babies with birth weight th centile ( P interaction =0.005), but more preterm birth ( P interaction =0.043), and no effect on perinatal death or high-level neonatal care hours ( P interaction =0.354). For the mother, less-tight (versus tight) control was associated with more severe hypertension at all gestational ages but particularly so before 28 weeks ( P interaction =0.076). In women with nonsevere, chronic, or gestational hypertension, there seems to be no gestational age at which less-tight (versus tight) control is the preferred management strategy to optimize maternal or perinatal outcomes. URL: www.isrctn.com . Unique identifier: ISRCTN71416914.
Publisher: Wiley
Date: 29-12-2016
DOI: 10.1111/AOGS.13051
Abstract: If hypertensive disorders of pregnancy are diagnosed before term, the benefits of immediate delivery need to be weighed against the neonatal consequences of preterm delivery. If we are able to predict which women are at high risk of progression to severe disease, they could be targeted for delivery and maternal complications might be reduced. In addition, this may prevent unnecessary preterm births in women at low risk. We developed a prediction model using data from the HYPITAT-II trail, which evaluated immediate delivery vs. expectant monitoring in women with non-severe hypertensive disorders of pregnancy between 34 and 37 weeks of gestation. Univariate and multivariate logistic regression analysis were used to identify relevant variables from clinical and laboratory parameters. The performance of the resulting prediction model was assessed by receiver operating characteristic analysis, calibration and bootstrapping, using the average predicted probabilities. We included 519 women, 115 (22.2%) of whom developed severe hypertensive disorders of pregnancy. The prediction model included: maternal age (odds ratio 0.92 per year), gestational age (odds ratio 0.87 per week), systolic blood pressure (odds ratio 1.05 per mmHg), the presence of chronic hypertension (odds ratio 2.4), platelet count (odds ratio 0.996), creatinine (odds ratio 1.02) and lactate dehydrogenase (odds ratio 1.003). The model showed good fit (p = 0.64), fair discrimination (area under the curve 0.76, 95% confidence interval 0.73-0.81, p < 0.001) and could stratify women in three risk groups of average, intermediate and high risk (predicted probabilities <0.22, 0.45, respectively). In women with non-severe hypertension in pregnancy near term, progression to severe disease can be predicted. This model requires external validation before it can be applied in practice.
Publisher: National Institute for Health and Care Research
Date: 04-2017
DOI: 10.3310/HTA21180
Abstract: The prognosis of early-onset pre-ecl sia (before 34 weeks’ gestation) is variable. Accurate prediction of complications is required to plan appropriate management in high-risk women. To develop and validate prediction models for outcomes in early-onset pre-ecl sia. Prospective cohort for model development, with validation in two external data sets. Model development: 53 obstetric units in the UK. Model transportability: PIERS (Pre-ecl sia Integrated Estimate of RiSk for mothers) and PETRA (Pre-Ecl sia TRial Amsterdam) studies. Pregnant women with early-onset pre-ecl sia. Nine hundred and forty-six women in the model development data set and 850 women (634 in PIERS, 216 in PETRA) in the transportability (external validation) data sets. The predictors were identified from systematic reviews of tests to predict complications in pre-ecl sia and were prioritised by Delphi survey. The primary outcome was the composite of adverse maternal outcomes established using Delphi surveys. The secondary outcome was the composite of fetal and neonatal complications. We developed two prediction models: a logistic regression model (PREP-L) to assess the overall risk of any maternal outcome until postnatal discharge and a survival analysis model (PREP-S) to obtain in idual risk estimates at daily intervals from diagnosis until 34 weeks. Shrinkage was used to adjust for overoptimism of predictor effects. For internal validation (of the full models in the development data) and external validation (of the reduced models in the transportability data), we computed the ability of the models to discriminate between those with and without poor outcomes ( c -statistic), and the agreement between predicted and observed risk (calibration slope). The PREP-L model included maternal age, gestational age at diagnosis, medical history, systolic blood pressure, urine protein-to-creatinine ratio, platelet count, serum urea concentration, oxygen saturation, baseline treatment with antihypertensive drugs and administration of magnesium sulphate. The PREP-S model additionally included exaggerated tendon reflexes and serum alanine aminotransaminase and creatinine concentration. Both models showed good discrimination for maternal complications, with anoptimism-adjusted c -statistic of 0.82 [95% confidence interval (CI) 0.80 to 0.84] for PREP-L and 0.75 (95% CI 0.73 to 0.78) for the PREP-S model in the internal validation. External validation of the reduced PREP-L model showed good performance with a c -statistic of 0.81 (95% CI 0.77 to 0.85) in PIERS and 0.75 (95% CI 0.64 to 0.86) in PETRA cohorts for maternal complications, and calibrated well with slopes of 0.93 (95% CI 0.72 to 1.10) and 0.90 (95% CI 0.48 to 1.32), respectively. In the PIERS data set, the reduced PREP-S model had a c -statistic of 0.71 (95% CI 0.67 to 0.75) and a calibration slope of 0.67 (95% CI 0.56 to 0.79). Low gestational age at diagnosis, high urine protein-to-creatinine ratio, increased serum urea concentration, treatment with antihypertensive drugs, magnesium sulphate, abnormal uterine artery Doppler scan findings and estimated fetal weight below the 10th centile were associated with fetal complications. The PREP-L model provided in idualised risk estimates in early-onset pre-ecl sia to plan management of high- or low-risk in iduals. The PREP-S model has the potential to be used as a triage tool for risk assessment. The impacts of the model use on outcomes need further evaluation. Current Controlled Trials ISRCTN40384046. The National Institute for Health Research Health Technology Assessment programme.
Publisher: Springer Science and Business Media LLC
Date: 12-2017
Publisher: Wiley
Date: 25-02-2021
Abstract: To examine the association between pre‐ecl sia definition and pregnancy outcome. Secondary analysis of Control of Hypertension in Pregnancy Study (CHIPS) trial data. International multicentre randomised controlled trial (RCT). In all, 987 women with non‐severe non‐proteinuric pregnancy hypertension. We evaluated the association between pre‐ecl sia definitions and adverse pregnancy outcomes, stratified by hypertension type and blood pressure control. Main CHIPS trial outcomes: primary (perinatal loss or high‐level neonatal care for hours), secondary (serious maternal complications), birthweight th centile, severe maternal hypertension, delivery at or weeks, and maternal hospitalisation before birth. Of 979/987 women with informative data, 280 (28.6%) progressed to pre‐ecl sia defined restrictively by new proteinuria, and 471 (48.1%) to pre‐ecl sia defined broadly as proteinuria or one/more maternal symptoms, signs or abnormal laboratory tests. The broad (versus restrictive) definition had significantly higher sensitivities (range 62–79% versus 36–50%), lower specificities (range 53–65% versus 72–82%), and similar or higher diagnostic odds ratios and ‘true‐positive’ to ‘false‐positive’ ratios. Stratified analyses showed similar results. Addition of available fetoplacental manifestations (stillbirth or birthweight th centile) to the broad pre‐ecl sia definition improved sensitivity (74–87%). A broad (versus restrictive) pre‐ecl sia definition better identifies women who develop adverse pregnancy outcomes. These findings should be replicated in a prospective study within routine healthcare to ensure that the anticipated increase in surveillance and intervention in a larger number of women with pre‐ecl sia is associated with improved outcomes, reasonable costs and congruence with women's values. A broad (versus restrictive) pre‐ecl sia definition better identifies the risk of adverse pregnancy outcomes.
Publisher: Massachusetts Medical Society
Date: 29-01-2015
Publisher: Elsevier BV
Date: 2020
DOI: 10.1016/J.EJOGRB.2019.11.001
Abstract: To compare effects of immediate delivery vs expectant monitoring on neurodevelopmental and behavioral outcomes at 5 years of age in offspring of women with mild late preterm hypertensive disorders. We studied children born during the HYPITAT-II trial, in which 704 women with a hypertensive disorder between 34 and 37 weeks of gestation were randomized to immediate delivery or expectant monitoring. Participating women were asked to complete the Ages and Stages Questionnaire (ASQ) for developmental outcome and the Child Behavior Checklist (CBCL) for behavioral problems when their child was 5 years old. Outcomes were dichotomized and analyzed by logistic regression analysis. We also assessed factors influencing development and behavior at both 2 and 5 years after a hypertensive pregnancy. Five years after the original study 322(46%) women were contacted for follow-up, of whom 148 (46%) responded. In the delivery group 22%(n = 14/65) of the children had an abnormal ASQ score compared to 21% (n = 13/62) in the expectant monitoring group (p = 0.9). Abnormal CBCL-scores were found in 19% (n = 14/72) of the children in the delivery group versus in 27% (n = 20/75) in the expectant monitoring group (p = 0.3). The main predictor of development and behavior at 2 and 5 years was fetal growth restriction (for abnormal development OR 2.1, CI 1.0-4.4 for behavior problems OR 2.2, CI 1.1-5.5). Higher maternal education decreased abnormal behavior outcomes (OR 0.5, CI 0.2-0.9) and a similar tendency was observed for developmental problems (OR 0.6, CI 0.3 - 1.1). We did not find different developmental and behavior outcomes at 5 years of age between a management policy of immediate delivery and expectant management in preterm hypertensive disorders. The increased risk of developmental delay at 2 years of age after immediate delivery, we found in the 2 year follow up study, did not persist at 5 years of age.
Publisher: Wiley
Date: 22-02-2023
DOI: 10.1111/AOGS.14520
Abstract: The incidence of induction of labor, for both medical reasons and as an elective procedure, has been rising and a further increase in induction of labor following the ARRIVE trial may be expected. The effects of induction of labor at term on childhood neurodevelopment, however, are not well studied. We aimed to study the influence of elective induction of labor for each week of gestation separately from 37 to 42 weeks on offspring school performance at 12 years of age after uncomplicated pregnancies. We performed a population‐based study among 226 684 liveborn children from uncomplicated singleton pregnancies, born from 37 +0 to 42 +0 weeks of gestation in cephalic presentation in 2003–2008 (no hypertensive disorders, diabetes or birthweight ≤p5) in the Netherlands. Children with congenital anomalies, of non‐white mothers and born after planned cesarean section were excluded. Birth records were linked with national data on school achievement. We compared, using a fetus‐at‐risk approach and per week of gestation, school performance score and secondary school level at age 12 in those born after induction of labor to those born after non‐intervention, ie spontaneous onset of labor in the same week plus all those born at later gestations. Education scores were standardized to a mean of 0 and a standard deviation of 1 and adjusted in the regression analyses. For each gestational age up to 41 weeks, induction of labor was associated with decreased school performance scores compared with non‐intervention (at 37 weeks −0.05 SD, 95% confidence interval [CI] −0.10 to −0.01 SD adjusted for confounding factors). After induction of labor, fewer children reached higher secondary school level (at 38 weeks 48% vs 54% adjusted odds ratio [aOR] 0.88, 95% CI 0.82–0.94). In women with uncomplicated pregnancies at term, consistently, at every week of gestation from 37 to 41 weeks, induction of labor is associated with lower offspring school performance at age 12 and lower secondary school level compared with non‐intervention, although residual confounding may remain. These long‐term effects of induction of labor should be incorporated in counseling and decision making.
Publisher: Springer Science and Business Media LLC
Date: 30-10-2018
Publisher: Elsevier BV
Date: 07-2020
DOI: 10.1016/J.PREGHY.2020.06.005
Abstract: To develop consensus definitions for the core outcome set for pre-ecl sia. Potential definitions for in idual core outcomes were identified across four formal definition development initiatives, nine national and international guidelines, 12 Cochrane systematic reviews, and 79 randomised trials. Eighty-six definitions were entered into the consensus development meeting. Ten healthcare professionals and three researchers, including six participants who had experience of conducting research in low- and middle-income countries, participated in the consensus development process. The final core outcome set was approved by an international steering group. Consensus definitions were developed for all core outcomes. When considering stroke, pulmonary oedema, acute kidney injury, raised liver enzymes, low platelets, birth weight, and neonatal seizures, consensus definitions were developed specifically for low- and middle-income countries because of the limited availability of diagnostic interventions including computerised tomography, chest x-ray, laboratory tests, equipment, and electroencephalogram monitoring. Consensus on measurements for the pre-ecl sia core outcome set will help to ensure consistency across future randomised trials and systematic reviews. Such standardization should make research evidence more accessible and facilitate the translation of research into clinical practice. Video abstract can be available at: /ftrgvrfu0u9glqd/6.%20Standardising%20definitions%20in%20teh%20pre-ecl sia%20core%20outcome%20set%3A%20a%20consensus%20development%20study.mp4?dl=0.
Publisher: Wiley
Date: 29-03-2020
DOI: 10.1002/UOG.20388
Abstract: Selective fetal growth restriction (sFGR) occurs in monochorionic twin pregnancies when unequal placental sharing leads to restriction in the growth of just one twin. Management options include laser separation of the fetal circulations, selective reduction or expectant management, but what constitutes the best treatment is not yet known. New trials in this area are urgently needed but, in this rare and complex group, maximizing the relevance and utility of clinical research design and outputs is paramount. A core outcome set ensures standardized outcome collection and reporting in future research. The objective of this study was to develop a core outcome set for studies evaluating treatments for sFGR in monochorionic twins. An international steering group of clinicians, researchers and patients with experience of sFGR was established to oversee the process of development of a core outcome set for studies investigating the management of sFGR. Outcomes reported in the literature were identified through a systematic review and informed the design of a three-round Delphi survey. Clinicians, researchers, and patients and family representatives participated in the survey. Outcomes were scored on a Likert scale from 1 (limited importance for making a decision) to 9 (critical for making a decision). Consensus was defined a priori as a Likert score of ≥ 8 in the third round of the Delphi survey. Participants were then invited to take part in an international meeting of stakeholders in which the modified nominal group technique was used to consider the consensus outcomes and agree on a final core outcome set. Ninety-six outcomes were identified from 39 studies in the systematic review. One hundred and three participants from 23 countries completed the first round of the Delphi survey, of whom 88 completed all three rounds. Twenty-nine outcomes met the a priori criteria for consensus and, along with six additional outcomes, were prioritized in a consensus development meeting, using the modified nominal group technique. Twenty-five stakeholders participated in this meeting, including researchers (n = 3), fetal medicine specialists (n = 3), obstetricians (n = 2), neonatologists (n = 3), midwives (n = 4), parents and family members (n = 6), patient group representatives (n = 3), and a sonographer. Eleven core outcomes were agreed upon. These were live birth, gestational age at birth, birth weight, intertwin birth-weight discordance, death of surviving twin after death of cotwin, loss during pregnancy or before final hospital discharge, parental stress, procedure-related adverse maternal outcome, length of neonatal stay in hospital, neurological abnormality on postnatal imaging and childhood disability. This core outcome set for studies investigating the management of sFGR represents the consensus of a large and erse group of international collaborators. Use of these outcomes in future trials should help to increase the clinical relevance of research on this condition. Consensus agreement on core outcome definitions and measures is now required. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.
Publisher: Elsevier BV
Date: 08-2014
DOI: 10.1016/J.EJOGRB.2014.05.021
Abstract: The internally validated fullPIERS model predicts adverse maternal outcomes in women with pre-ecl sia within 48h after eligibility. Our objective was to assess generalizability of this prediction model. External validation study using prospectively collected data from two tertiary care obstetric centers. The existing PETRA dataset, a cohort of women (n=216) with severe early-onset pre-ecl sia, ecl sia, HELLP syndrome or hypertension-associated fetal growth restriction was used. The fullPIERS model equation was applied to all women in the dataset using values collected within 48h after inclusion. The performance (ROC area and R-squared) of the model, risk stratification and calibration were assessed from 48h up to a week after inclusion. Of 216 women in the PETRA trial, 73 (34%) experienced an adverse maternal outcome(s) at any time after inclusion. Adverse maternal outcome was observed in 32 (15%) cases within 48h and 62 (29%) within 7 days after inclusion. The fullPIERS model predicted adverse maternal outcomes within 48h (AUC ROC 0.97, 95% CI: 0.87-0.99) and up to 7 days after inclusion (AUC ROC 0.80, 95% CI: 0.70-0.87). The fullPIERS model performed well when applied to the PETRA dataset. These results confirm the usability of the fullPIERS prediction model as a 'rule-in' test for women admitted with severe pre-ecl sia, ecl sia, HELLP syndrome or hypertension-associated fetal growth restriction. Future research should focus on intervention studies that assess the clinical impact of strategies using the fullPIERS model.
Publisher: Wiley
Date: 28-08-2020
DOI: 10.1111/AOGS.13976
Publisher: Wiley
Date: 06-08-2018
DOI: 10.1002/UOG.19186
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 06-2020
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 04-2018
DOI: 10.1161/HYPERTENSIONAHA.117.10318
Abstract: Early-onset preecl sia is associated with severe maternal and perinatal complications. The fullPIERS model (Preecl sia Integrated Estimate of Risk) showed both internal and external validities for predicting adverse maternal outcomes within 48 hours for women admitted with preecl sia at any gestational age. This ability to recognize women at the highest risk of complications earlier could aid in preventing these adverse outcomes through improved management. Because the majority (≈70%) of the women in the model development had late-onset preecl sia, we assessed the performance of the fullPIERS model in women with early-onset preecl sia to determine whether it will be useful in this subgroup of women with preecl sia. Three cohorts of women admitted with early-onset preecl sia between 2012 and 2016, from tertiary hospitals in Canada, the Netherlands, and United Kingdom, were used. Using the published model equation, the probability of experiencing an adverse maternal outcome was calculated for each woman, and model performance was evaluated based on discrimination, calibration, and stratification. The total data set included 1388 women, with an adverse maternal outcome rate of 7.3% within 48 hours of admission. The model had good discrimination, with an area under the receiver operating characteristic curve of 0.80 (95% confidence interval, 0.75–0.86), and a calibration slope of 0.68. The estimated likelihood ratio at the predicted probability of ≥30% was 23.4 (95% confidence interval, 14.83–36.79), suggesting a strong evidence to rule in adverse maternal outcomes. The fullPIERS model will aid in identifying women admitted with early-onset preecl sia in similar settings who are at the highest risk of adverse outcomes, thereby allowing timely and effective interventions.
Publisher: Wiley
Date: 06-2023
DOI: 10.1111/PPE.12990
Abstract: Gestational age is positively associated with cognitive development, but socio‐demographic factors also influence school performance. Previous studies suggested possible interaction, putting children with low socio‐economic status (SES) at increased risk of the negative effects of prematurity. To investigate the association between gestational age in weeks, socio‐demographic characteristics, and school performance at the age of 12 years among children in regular primary education. Population‐based cohort study among liveborn singletons ( N = 860,332) born in the Netherlands in 1999–2006 at 25–42 weeks' gestation, with school performance from 2011 to 2019. Regression analyses were conducted investigating the association of gestational age and sociodemographic factors with school performance and possible interaction. School performance increased with gestational age up to 40 weeks. This pattern was evident across socio‐demographic strata. Children born at 25 weeks had −0.57 SD (95% confidence interval −0.79, −0.35) lower school performance z‐scores and lower secondary school level compared to 40 weeks. Low maternal education, low maternal age, and non‐European origin were strongly associated with lower school performance. Being born third or later and low socioeconomic status (SES) were also associated with lower school performance, but differences were smaller than among other factors. When born preterm, children from mothers with low education level, low or high age, low SES or children born third or later were at higher risk for lower school performance compared to children of mothers with intermediate education level, aged 25–29 years, with intermediate SES or first borns (evidence of interaction). Higher gestational age is associated with better school performance at the age of 12 years along the entire spectrum of gestational age, beyond the cut‐off of preterm birth and across socio‐demographic differences. Children in socially or economically disadvantaged situations might be more vulnerable to the negative impact of preterm birth. Other important factors in school performance are maternal education, maternal age, ethnicity, birth order and SES. Results should be interpreted with caution due to differential loss to follow‐up.
Publisher: Elsevier BV
Date: 05-2023
Publisher: Wiley
Date: 08-06-2020
Publisher: Wiley
Date: 20-08-2020
DOI: 10.1111/AJO.13227
Publisher: BMJ
Date: 22-11-2018
DOI: 10.1136/BMJ.K4872
Publisher: Springer Science and Business Media LLC
Date: 02-11-2020
DOI: 10.1186/S12916-020-01766-9
Abstract: Pre-ecl sia is a leading cause of maternal and perinatal mortality and morbidity. Early identification of women at risk during pregnancy is required to plan management. Although there are many published prediction models for pre-ecl sia, few have been validated in external data. Our objective was to externally validate published prediction models for pre-ecl sia using in idual participant data (IPD) from UK studies, to evaluate whether any of the models can accurately predict the condition when used within the UK healthcare setting. IPD from 11 UK cohort studies (217,415 pregnant women) within the International Prediction of Pregnancy Complications (IPPIC) pre-ecl sia network contributed to external validation of published prediction models, identified by systematic review. Cohorts that measured all predictor variables in at least one of the identified models and reported pre-ecl sia as an outcome were included for validation. We reported the model predictive performance as discrimination ( C -statistic), calibration (calibration plots, calibration slope, calibration-in-the-large), and net benefit. Performance measures were estimated separately in each available study and then, where possible, combined across studies in a random-effects meta-analysis. Of 131 published models, 67 provided the full model equation and 24 could be validated in 11 UK cohorts. Most of the models showed modest discrimination with summary C -statistics between 0.6 and 0.7. The calibration of the predicted compared to observed risk was generally poor for most models with observed calibration slopes less than 1, indicating that predictions were generally too extreme, although confidence intervals were wide. There was large between-study heterogeneity in each model’s calibration-in-the-large, suggesting poor calibration of the predicted overall risk across populations. In a subset of models, the net benefit of using the models to inform clinical decisions appeared small and limited to probability thresholds between 5 and 7%. The evaluated models had modest predictive performance, with key limitations such as poor calibration (likely due to overfitting in the original development datasets), substantial heterogeneity, and small net benefit across settings. The evidence to support the use of these prediction models for pre-ecl sia in clinical decision-making is limited. Any models that we could not validate should be examined in terms of their predictive performance, net benefit, and heterogeneity across multiple UK settings before consideration for use in practice. PROSPERO ID: CRD42015029349 .
Publisher: Elsevier BV
Date: 11-2016
DOI: 10.1016/J.EJOGRB.2016.07.509
Abstract: To compare women's views about blood pressure (BP) control in CHIPS (Control of Hypertension In Pregnancy Study) (NCT01192412). Quantitative and qualitative analysis of questionnaire responses. International randomised trial (94 sites, 15 countries). 911 (92.9%) women randomised to 'tight' (target diastolic blood pressure, 85mmHg) or 'less tight' (target diastolic blood pressure, 100mmHg) who completed questionnaires. A questionnaire was administered at ∼6-12 weeks postpartum regarding post-discharge morbidity and views about trial participation. Questionnaires were administered by the site co-ordinator, and contact was made by phone, home or clinic visit rarely, data was collected from medical records. Quantitative analyses were Chi-square or Fisher's exact test for categorical variables, mixed effects multinomial logistic regression to adjust for confounders, and p<0.001 for statistical significance. NVivo software was used for thematic analysis of women's views. Satisfaction, measured as willingness to have the same treatment in another pregnancy or recommend that treatment to a friend. Among the 533 women in 'tight' (N=265) vs. 'less tight' (N=268) control who provided comments for qualitative analysis, women in 'tight' (vs. 'less tight') control made fewer positive comments about the amount of medication taken (5 vs. 28 women, respectively) and intensity of BP monitoring (7 vs. 17, respectively). However, this did not translate into less willingness to either have the same treatment in another pregnancy (434, 95.8% vs. 423, 92.4%, respectively p=0.14) or recommend that treatment to a friend (435, 96.0% and 428, 93.4%, respectively p=0.17). Importantly, although satisfaction remained high among women with an adverse outcome, those in 'tight' control who suffered an adverse outcome (vs. those who did not) were not consistently less satisfied, whereas this was not the case among women in 'less tight' control among whom satisfaction was consistently lower for the CHIPS primary outcome (p<0.001), severe hypertension (p≤0.01), and pre-ecl sia (p<0.001). Women in 'tight' (vs. 'less tight') control were equally satisfied with their care, and more so in the face of adverse perinatal or maternal outcomes.
Publisher: Springer Science and Business Media LLC
Date: 30-03-2017
Publisher: Wiley
Date: 11-08-2015
Abstract: To compare pregnancy outcomes, accounting for allocated group, between methyldopa-treated and labetalol-treated women in the CHIPS Trial (ISRCTN 71416914) of 'less tight' versus 'tight' control of pregnancy hypertension. Secondary analysis of CHIPS Trial cohort. International randomised controlled trial (94 sites, 15 countries). Of 987 CHIPS recruits, 481/566 (85.0%) women treated with antihypertensive therapy at randomisation. Of 981 (99.4%) women followed to delivery, 656/745 (88.1%) treated postrandomisation. Logistic regression to compare outcomes among women who took methyldopa or labetalol, adjusted for the influence of baseline factors. CHIPS primary (perinatal loss or high level neonatal care for >48 hours) and secondary (serious maternal complications) outcomes, birthweight <10th centile, severe maternal hypertension, pre-ecl sia and delivery at <34 or <37 weeks. Methyldopa and labetalol were used commonly at randomisation (243/987, 24.6% and 238/987, 24.6%, respectively) and post-randomisation (224/981, 22.8% and 433/981, 44.1%, respectively). Following adjusted analyses, methyldopa (versus labetalol) at randomisation was associated with fewer babies with birthweight <10th centile [adjusted odds ratio (aOR) 0.48 95% CI 0.20-0.87]. Methyldopa (versus labetalol) postrandomisation was associated with fewer CHIPS primary outcomes (aOR 0.64 95% CI 0.40-1.00), birthweight <10th centile (aOR 0.54 95% CI 0.32-0.92), severe hypertension (aOR 0.51 95% CI 0.31-0.83), pre-ecl sia (aOR 0.55 95% CI 0.36-0.85), and delivery at <34 weeks (aOR 0.53 95% CI 0.29-0.96) or <37 weeks (aOR 0.55 95% CI 0.35-0.85). These nonrandomised comparisons are subject to residual confounding, but women treated with methyldopa (versus labetalol), particularly those with pre-existing hypertension, may have had better outcomes. There was no evidence that women treated with methyldopa versus labetalol had worse outcomes.
Publisher: Wiley
Date: 12-02-2021
DOI: 10.1111/AOGS.14074
Abstract: Preterm birth is a major cause of perinatal morbidity and mortality worldwide. In many countries preterm birth rates are increasing, largely as a result of increases in iatrogenic preterm birth, whereas in other countries rates are stable or even declining. The objective of the study is to describe trends in singleton preterm births in Victoria from 2007 to 2017 in relation to trends in perinatal mortality to identify opportunities for improvements in clinical care. We conducted a consecutive cross‐sectional study in all women with a singleton pregnancy giving birth at ≥20 weeks of pregnancy in Victoria, Australia, between 2007 and 2017, inclusive. Rates of preterm birth and perinatal mortality were calculated and trends were analyzed in all pregnancies, in pregnancies complicated by fetal growth problems, hypertension, (pre)ecl sia or prelabor rupture of membranes (PROM), and in (low‐risk) pregnancies not complicated by any of these conditions. There were 811 534 singleton births between 2007 and 2017. Preterm birth increased from 5.9% (4074 births) to 6.4% (4893 births P .001), due to an increase in iatrogenic preterm birth from 2.5% (1730 births) to 3.6% (2730 births P .001). Comparable trends were seen in pregnancies complicated by fetal growth problems and hypertension and in pregnancies not complicated by small for gestational age (SGA), hypertension, (pre)ecl sia or PROM (all P .001). In pregnancies complicated by SGA, hypertension, (pre)ecl sia or PROM the perinatal mortality rate from 20 weeks of gestation fell (13 to 12 per 1000 births P .001). In pregnancies not complicated by SGA, hypertension, (pre)ecl sia or PROM there was no significant change in the perinatal mortality from 28 weeks and no decrease in the preterm weekly prospective stillbirth risk. The singleton preterm birth rate in Victoria is increasing, driven by an increase in iatrogenic preterm birth, both in pregnancies complicated by SGA and hypertension, and in pregnancies not complicated by SGA, hypertension, (pre)ecl sia or PROM. While perinatal mortality decreased in the pregnancies complicated by SGA, hypertension, (pre)ecl sia or PROM, no significant reduction in perinatal mortality from 28 weeks or in preterm weekly prospective stillbirth risk was noted in the pregnancies not complicated by any of these conditions.
Publisher: Wiley
Date: 11-08-2015
Abstract: To determine whether the difference in outcomes between 'less tight' (target diastolic blood pressure [dBP] of 100 mmHg) versus 'tight' control (target dBP of 85 mmHg) in the CHIPS Trial (ISRCTN 71416914, pre-empt.cfri.ca/ CHIPS) depended on the choice of labetalol or methyldopa, the two most commonly used antihypertensive agents in CHIPS. Secondary analysis of CHIPS Trial data. International multicentre randomised controlled trial (94 sites, 15 countries). A total of 987 women with non-severe non-proteinuric pregnancy hypertension. Logistic regression was used for comparisons of 'less tight' versus 'tight' control among women treated with labetalol (but not methydopa) versus methyldopa (but not labetalol). Analyses were adjusted for the influence of baseline factors, including use of any antihypertensive therapy at randomisation. Main CHIPS Trial outcomes: primary (perinatal loss or high-level neonatal care for > 48 hours), secondary (serious maternal complications), birthweight < 10th centile, severe maternal hypertension, pre-ecl sia, and delivery at < 34 or < 37 weeks. Of 987 women in CHIPS, antihypertensive therapy was taken by 566 women at randomisation (labetalol 111 ['less tight'] versus 127 ['tight'] or methyldopa 126 ['less tight'] versus 117 ['tight']) and 815 women after randomisation (labetalol 186 ['less tight'] versus 247 ['tight'] and methyldopa by 98 ['less tight'] versus 126 ['tight']). Following adjustment, odds ratios for outcomes in 'less tight' versus 'tight' control were similar between antihypertensive groups according to 'at randomisation' and 'after randomisation' therapy. Outcomes for 'less tight' versus 'tight' control were not dependent on use of methyldopa or labetalol. In the CHIPS Trial, maternal and infant outcomes were not dependent on use of labetalol or methyldopa.
Publisher: Wiley
Date: 21-06-2020
Publisher: Elsevier BV
Date: 10-2018
DOI: 10.1016/J.PREGHY.2018.04.021
Abstract: As a follow-up to the CHIPS trial (Control of Hypertension In Pregnancy Study) of 'less tight' (versus 'tight') control of maternal blood pressure in pregnancy, CHIPS-Child investigated potential developmental programming of maternal blood pressure control in pregnancy, by examining measures of postnatal growth rate and hypothalamic-pituitary adrenal (HPA) axis activation. CHIPS follow-up was extended to 12 ± 2 months corrected post-gestational age for anthropometry (weight, length, head/waist circumference). For eligible children with consent for a study visit, we collected biological s les (hair/buccal s les) to evaluate HPA axis function (hair cortisol levels) and epigenetic change (DNA methylation analysis of buccal cells). The primary outcome was 'change in z-score for weight' between birth and 12 ± 2 mos. Secondary outcomes were hair cortisol and genome-wide DNA methylation status. Of 683 eligible babies, 183 (26.8%) were lost to follow-up, 83 (12.2%) declined, 3 (0.4%) agreed only to ongoing contact, and 414 (60.6%) consented. 372/414 (89.9%) had weight measured at 12mos. In 'less tight' (vs. 'tight') control, the primary outcome was similar [-0.26 (-0.53, +0.01) p = 0.14, p Results demonstrate no compelling evidence for developmental programming of growth or the HPA axis. Clinicians should look to the clinical findings of CHIPS to guide practice. Researchers should seek to replicate these findings and extend outcomes to paediatric blood pressure and neurodevelopment.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 2020
Publisher: Springer Science and Business Media LLC
Date: 11-03-2014
Publisher: National Institute for Health and Care Research
Date: 12-2020
DOI: 10.3310/HTA24720
Abstract: Pre-ecl sia is a leading cause of maternal and perinatal mortality and morbidity. Early identification of women at risk is needed to plan management. To assess the performance of existing pre-ecl sia prediction models and to develop and validate models for pre-ecl sia using in idual participant data meta-analysis. We also estimated the prognostic value of in idual markers. This was an in idual participant data meta-analysis of cohort studies. Source data from secondary and tertiary care. We identified predictors from systematic reviews, and prioritised for importance in an international survey. Early-onset (delivery at 34 weeks’ gestation), late-onset (delivery at ≥ 34 weeks’ gestation) and any-onset pre-ecl sia. We externally validated existing prediction models in UK cohorts and reported their performance in terms of discrimination and calibration. We developed and validated 12 new models based on clinical characteristics, clinical characteristics and biochemical markers, and clinical characteristics and ultrasound markers in the first and second trimesters. We summarised the data set-specific performance of each model using a random-effects meta-analysis. Discrimination was considered promising for C -statistics of ≥ 0.7, and calibration was considered good if the slope was near 1 and calibration-in-the-large was near 0. Heterogeneity was quantified using I 2 and τ 2 . A decision curve analysis was undertaken to determine the clinical utility (net benefit) of the models. We reported the unadjusted prognostic value of in idual predictors for pre-ecl sia as odds ratios with 95% confidence and prediction intervals. The International Prediction of Pregnancy Complications network comprised 78 studies (3,570,993 singleton pregnancies) identified from systematic reviews of tests to predict pre-ecl sia. Twenty-four of the 131 published prediction models could be validated in 11 UK cohorts. Summary C -statistics were between 0.6 and 0.7 for most models, and calibration was generally poor owing to large between-study heterogeneity, suggesting model overfitting. The clinical utility of the models varied between showing net harm to showing minimal or no net benefit. The average discrimination for IPPIC models ranged between 0.68 and 0.83. This was highest for the second-trimester clinical characteristics and biochemical markers model to predict early-onset pre-ecl sia, and lowest for the first-trimester clinical characteristics models to predict any pre-ecl sia. Calibration performance was heterogeneous across studies. Net benefit was observed for International Prediction of Pregnancy Complications first and second-trimester clinical characteristics and clinical characteristics and biochemical markers models predicting any pre-ecl sia, when validated in singleton nulliparous women managed in the UK NHS. History of hypertension, parity, smoking, mode of conception, placental growth factor and uterine artery pulsatility index had the strongest unadjusted associations with pre-ecl sia. Variations in study population characteristics, type of predictors reported, too few events in some validation cohorts and the type of measurements contributed to heterogeneity in performance of the International Prediction of Pregnancy Complications models. Some published models were not validated because model predictors were unavailable in the in idual participant data. For models that could be validated, predictive performance was generally poor across data sets. Although the International Prediction of Pregnancy Complications models show good predictive performance on average, and in the singleton nulliparous population, heterogeneity in calibration performance is likely across settings. Recalibration of model parameters within populations may improve calibration performance. Additional strong predictors need to be identified to improve model performance and consistency. Validation, including examination of calibration heterogeneity, is required for the models we could not validate. This study is registered as PROSPERO CRD42015029349. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment Vol. 24, No. 72. See the NIHR Journals Library website for further project information.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 05-2022
DOI: 10.1161/HYPERTENSIONAHA.121.18356
Abstract: There is no accepted definition or standardized monitoring for white coat hypertension in pregnancy. This Delphi procedure aimed to reach consensus on out-of-office blood pressure (BP) monitoring, and white coat hypertension diagnostic criteria and monitoring. Relevant international experts completed three rounds of a modified Delphi questionnaire. For each item, the predefined cutoff for group consensus was ≥70% agreement, with 60% to 70% considered to warrant reconsideration at the subsequent round, and % considered insufficient to warrant consideration. Of 230 experts, 137 completed the first round and 114 (114/137, 83.2%) completed all three. For out-of-office BP monitoring, there was consensus that home BP monitoring (HBPM) should be chosen instructions given, pairs of BP values taken, opportunity given for women to qualify values they do not regard as valid, and BP considered evaluated when ≥25% of values are above a cutoff. For HBPM, BP should be taken at least 2 to 3 d/wk, at minimum in the morning however, many factors may affect frequency and timing. Experts endorsed a clinic BP /90 mm Hg as normal. While not reaching consensus, most agreed that HBPM values should be lower than clinic BP. Among those, HBPM /85 mm Hg was considered normal. There was consensus that white coat hypertension warrants: HBPM at least 1 d/wk before 20 weeks, 2 to 3 d/wk after 20 weeks or if persistent hypertension develops, and symptom monitoring (ie, headache, visual symptoms, and right upper quadrant/epigastric pain). Consensus-based diagnostic criteria and monitoring strategies should inform clinical care and research, to facilitate evaluation of out-of-office BP monitoring on pregnancy outcomes.
Publisher: S. KARGER AG
Date: 2014
DOI: 10.1159/000356109
Publisher: BMJ
Date: 08-2018
DOI: 10.1136/BMJOPEN-2018-021619
Abstract: To establish pregnancy, the maternal immune system must adapt to tolerate the semiallogenic fetus. Less than optimal adaptation of the maternal immune system during (early) pregnancy is implicated in several complications of pregnancy. The development of effective immune modulation interventions as preventive or therapeutic strategies for pregnancy complications holds promise. Several studies sought to evaluate the safety and effectiveness of various approaches. However, a limitation is the high variability in clinical and immune outcomes that are reported. We, therefore, aim to develop a core outcome set for application to studies of immune modulation in pregnancy (COSIMPREG). We will use a stepwise approach to develop a COSIMPREG. First, we will perform a systematic review to identify reported outcomes. For this review, Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be followed. Second, we will use the Delphi method to develop a preliminary COSIMPREG. In three rounds, the outcomes of the systematic review will be scored. A panel comprising experts from relevant disciplines and erse geographical locations will be assembled until a sufficient quality of the panel is reached. We will use predefined decision rules for outcomes. After each round outcomes, including scores, will be returned to the panel for further refinement. The outcomes not excluded after the third round will be taken to a consensus meeting. In this meeting, experts from all relevant disciplines will discuss and finalise the COSIMPREG. For this study ethical approval is not required. The systematic review will be published in an appropriate open access reproductive immunology journal. Once the COSIMPREG is finalised, it will be published in an open access reproductive immunology journal, and disseminated at appropriate international meetings, as well as through relevant research and scientific societies. Experts involved in the Delphi study will be asked to give informed consent.
Location: Netherlands
No related grants have been discovered for Wessel Ganzevoort.