scholarly journals Study protocol: establishment of a multicentre pre-eclampsia database and biobank in Sweden: GO PROVE and UP MOST, a prospective cohort study

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e049559
Author(s):  
Lilja Thorgeirsdottir ◽  
Malin Andersson ◽  
Ove Karlsson ◽  
Sven-Egron Thörn ◽  
Jonatan Oras ◽  
...  

IntroductionPre-eclampsia, a multisystem disorder in pregnancy, is one of the most common causes of maternal morbidity and mortality worldwide. However, we lack methods for objective assessment of organ function in pre-eclampsia and predictors of organ impairment during and after pre-eclampsia. The women’s and their partners’ experiences of pre-eclampsia have not been studied in detail. To phenotype different subtypes of the disorder is of importance for prediction, prevention, surveillance, treatment and follow-up of pre-eclampsia.The aim of this study is to set up a multicentre database and biobank for pre-eclampsia in order to contribute to a safer and more individualised treatment and care.Methods and analysisThis is a multicentre cohort study. Prospectively recruited pregnant women ≥18 years, diagnosed with pre-eclampsia presenting at Sahlgrenska University Hospital, Uppsala University Hospital and at Södra Älvsborgs Hospital, Sweden, as well as normotensive controls are eligible for participation. At inclusion and at 1-year follow-up, the participants donate biosamples that are stored in a biobank and they are also asked to participate in various organ-specific evaluations. In addition, questionnaires and interviews regarding the women’s and partner’s experiences are distributed at follow-up.Ethics and disseminationBy creating a database and biobank, we will provide the means to explore the disorder in a broader sense and allow clinical and laboratory discoveries that can be translated to clinical trials aiming at improved care of women with pre-eclampsia. Further, to evaluate experiences and the psychological impact of being affected by pre-eclampsia can improve the care of pregnant women and their partners. In case of incidental pathological findings during examinations performed, they will be handled in accordance with clinical routine. Data are stored in a secure online database. Biobank samples are identified through the women’s personal identification number and pseudonymised after identification in the biobank before analysis.This study was approved by the regional ethical review board in Gothenburg on 28 December 2018 (approval number 955-18) and by the Swedish Ethical Review Authority on 27 February 2019 (approval number 2019-00309).Results from the study will be published in international peer-reviewed journals.Trial registration numberISRCTN13060768

2021 ◽  
pp. 140349482110224
Author(s):  
Mikael O. Ekblad ◽  
Hanna P. Wallin ◽  
Marjukka Pajulo ◽  
Päivi E. Korhonen

Aims: The primary aim of the study is to explore different factors affecting parents’ smoking behaviour, and especially how smoking may be connected with individual differences in the psychological process of becoming a parent. In the current paper, we present the study design together with basic information on the study population. Methods: The Central Satakunta Maternity and Child Health Clinic (KESALATU) Study is an ongoing prospective follow-up study in primary healthcare of the Satakunta region of southwest Finland. Families were recruited during their first maternity clinic visit between 1 September 2016 and 31 December 2019, and participation will continue until the child is 1.5 years of age. The study combines different sources and types of data: e.g. routine data obtained from primary healthcare clinic records, specific parental self-report data and data from a new exhaled carbon monoxide meter indicating maternal smoking. The data are collected using frequently repeated assessments both during pregnancy and postnatally. The methods cover the following areas of interest: family background factors (including smoking and alcohol use), self-reported parental–foetal/infant attachment and mentalization, self-reported stress, depression and quality of life. Results: 589 pregnant women and their partners were asked to participate in the study during the collection time period. The final study population consisted of 248 (42.1%) pregnant women and 160 (27.1%) partners. Conclusions: The new methods and study design have the potential to increase our understanding about the link between early parenting psychology, prenatal psychosocial risk factors and parental health behaviour.


BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e044933
Author(s):  
Tianchen Lyu ◽  
Yunli Chen ◽  
Yongle Zhan ◽  
Yingjie Shi ◽  
Hexin Yue ◽  
...  

PurposeA multicentre prospective cohort study, known as the Chinese Pregnant Women Cohort Study (CPWCS), was established in 2017 to collect exposure data during pregnancy (except environmental exposure) and analyse the relationship between lifestyle during pregnancy and obstetric outcomes. Data about mothers and their children’s life and health as well as children’s laboratory testing will be collected during the offspring follow-up of CPWCS, which will enable us to further investigate the longitudinal relationship between exposure in different periods (during pregnancy and childhood) and children’s development.Participants9193 pregnant women in 24 hospitals in China who were in their first trimester (5–13 weeks gestational age) from 25 July 2017 to 26 November 2018 were included in CPWCS by convenience sampling. Five hospitals in China which participated in CPWCS with good cooperation will be selected as the sample source for the Chinese Pregnant Women Cohort Study (Offspring Follow-up) (CPWCS-OF).Findings to dateSome factors affecting pregnancy outcomes and health problems during pregnancy have been discovered through data analysis. The details are discussed in the ‘Findings to date’ section.Future plansInfants and children and their mothers who meet the criteria will be enrolled in the study and will be followed up every 2 years. The longitudinal relationship between exposure (questionnaire data, physical examination and biospecimens, medical records, and objective environmental data collected through geographical information system and remote sensing technology) in different periods (during pregnancy and childhood) and children’s health (such as sleeping problem, oral health, bowel health and allergy-related health problems) will be analysed.Trail registration numberCPWCS was registered with ClinicalTrials.gov on 18 January 2018: NCT03403543. CPWCS-OF was registered with ClinicalTrials.gov on 24 June 2020: NCT04444791.


Author(s):  
Amanda Andrade Diesel ◽  
Suzana de Azevedo Zachia ◽  
Ana Lúcia Letti Müller ◽  
Amanda Vilaverde Perez ◽  
Flavio Antonio de Freitas Uberti ◽  
...  

Abstract Objective To describe a population of pregnant women diagnosed with toxoplasmosis and their respective newborns, describing the hospital protocol for treatment and follow-up. Methods Retrospective cohort of pregnant women with acute toxoplasmosis infection and risk of transplacental transmission who were sent to the Fetal Medicine Group of Hospital de Clínicas de Porto Alegre (HCPA) between - January 1, 2006 and December 31, 2016. All patients with confirmed disease were included. The diagnostic protocol and treatment were applied; a polymerase chain reaction (PCR) analysis of the amniotic fluid was used to diagnose toxoplasmosis and determine the treatment. The newborns were followed up at the pediatric outpatient clinic specializing in congenital infection. The patients who were not followed up or were not born in the HCPA were excluded. Results A total of 65 patients were confirmed to have gestational toxoplasmosis; 40 performed amniocentesis, and 6 (15%) were identified as having positive PCR in the amniotic fluid. In five of those cases, this result associated with the gestational age defined the triple therapy during pregnancy, and in one case, it defined the monotherapy (advanced gestational age). A total of 4 of these newborns were treated from birth with triple therapy for 10 months, 1 was not treated (due to maternal refusal), and 1 progressed to death within the first 54 hours of life due to complications of congenital toxoplasmosis. Of the 34 remaining cases with a negative PCR, 33 were treated with monotherapy and 1 was treated with triple therapy (ultrasound findings); of these children, 9 (26.5%) presented negative immunoglobulin G (IgG), 24 (70.6%) presented positive IgG (but none presented positive immunoglobulin M [IgM]), and 1 (2,9%) presented alterations compatible with congenital disease and started treatment with the triple therapy soon after birth. Out of the total sample of 60 patients, among the 25 who did not perform amniotic fluid PCR, 5 were treated with triple therapy (ultrasound findings/prior treatment) and 20 patients were submitted to monotherapy; only two newborns underwent treatment for congenital toxoplasmosis. Among the 65 cases of gestational toxoplasmosis, 6 (9,2%) children had a diagnosis of congenital toxoplasmosis, and 2 patients with triple therapy felt severe adverse effects of the medications. Conclusions The present study suggests that research on PCR screening of the amniotic fluid may be useful to identify patients with a higher potential for fetal complications, who may benefit from the poly-antimicrobial treatment. Patients with negative PCR results must continue to prevent fetal infection with monotherapy, without risk of fetal or maternal impairment.


2017 ◽  
Vol 4 (2) ◽  
pp. 53
Author(s):  
Liza Sels ◽  
Joachim Van Calster ◽  
Steven Vanderschueren ◽  
Liesbet Henckaerts

Introduction: The Vogt-Koyanagi-Harada syndrome (VKHS) is rare in Europe. Bilateral panuveitis is the defining characteristic, but the disease can affect other tissues containing melanin, such as the inner ear, the meninges, and the skin. Therefore, patients may present not only to ophthalmologists, but also to internists, dermatologists, ENT-physicians and neurologists. Early and aggressive immunosuppressive treatment is necessary in order to prevent permanent visual loss or systemic complications.Objective: We retrospectively studied 12 patients diagnosed and treated in a specialized uveitis clinic in Leuven (Belgium) between 2005 and 2013, and we compared our data with literature.Results:  The most common extra-ocular manifestations were neurological, with headache (100%) and lymphocytic meningitis (75%) as main findings. Tinnitus was present in 50%, and vertigo in 42%. Vitiligo was the most frequent dermatological manifestation and present in 42%. Uveitis recurred in 67% of patients with 1 to 4 relapses per patient and a median time to recurrence of 6 months (range 1-11). Normal visual acuity was seen in 75% of patients at the end of follow-up (5 to 60 months), but 3 patients had at least some degree of permanent visual impairment in at least one eye.Conclusion: VKHS is a rare, multisystem disorder, characterized by bilateral uveitis and variable neurologic, auditory and skin symptoms. A lumbar puncture increases the diagnostic yield. A fast diagnosis allows timely initiation of adequate therapy, and If treated correctly, VKHS has a favorable prognosis. It is unclear if initial intravenous therapy improves frequency and time to remission.


BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e020028 ◽  
Author(s):  
Lena Van den Eeden ◽  
Nathalie Lambrechts ◽  
Veerle Verheyen ◽  
Mario Berth ◽  
Greet Schoeters ◽  
...  

IntroductionAir pollution is a hot topic and is known to cause multiple health issues. Especially pregnant women seem to be vulnerable to environmental issues. There are data suggesting that exposure contributes to hypertensive disorders.This study aims to evaluate the effects of exposure to particulate matter (PM) and outdoor air pollutants on the clinical pregnancy outcome for mother and child and to determine which biochemical changes in maternal, placental and cord blood best explain this effect.Methods and analysisThis study is a prospective cohort study. We aim to recruit 200 pregnant women. The outcome measurements will include maternal parameters, labour parameters and neonatal parameters.Multiple samples will be analysed such as maternal urine samples (8-oxo-deoxyguanosine), maternal blood samples (routine blood sampling, biomarkers of pre-eclampsia and transcript markers), maternal hair samples, neonatal blood samples (transcript markers) combined with extensive questionnaires.Ethics and disseminationWe obtain informed consent from each participant prior to enrolment in the study.The study has received approval by the Ethical Committee of the Antwerp University Hospital (14/40/411).IPANEMA is the first prospective study to assess the impact of PM on mothers and babies in Antwerp, Belgium.Findings from this study will contribute to improve knowledge on the impact of exposure to air pollution on mothers and babies and will also define biomarkers as predictors for pregnant women at risk.Trial registrationClinicalTrials.gov: 14/40/411. Registered 22-10-2015.


2019 ◽  
Vol 31 (2) ◽  
pp. 166-173
Author(s):  
Eleanor P Bergquist ◽  
Anne Trolard ◽  
Anne S Kuhlmann ◽  
Travis Loux ◽  
Stephen Y Liang ◽  
...  

The objective of this study is to evaluate whether pregnant women receive appropriate treatment, undertreatment, or overtreatment in the emergency department (ED) when they are tested for chlamydia and gonorrhea as compared to non-pregnant women. In a retrospective cohort study, we analyzed visits made to an urban ED from 1 July 2012 to 30 June 2014, with testing for chlamydia and gonorrhea (n = 3908). Using multiple logistic regression, we compared undertreatment and overtreatment in women controlling for pregnancy, age, race, and sexually transmitted infection International Statistical Classifications of Diseases (ICD)-9 coded diagnosis. Pregnant women were significantly more likely to be undertreated when positive for infection as compared to non-pregnant women (OR 2.94; 95% CI, 1.47–5.95) and significantly less likely to be overtreated when negative for infection (OR 0.40; 95% CI, 0.31–0.53) as compared to non-pregnant women. Pregnant women may not be receiving appropriate treatment when they present to the ED with chlamydia or gonorrhea. Attention should be paid to this group when administering chlamydia and gonorrhea treatment to ensure appropriate care and follow-up.


Author(s):  
Magda Magalhães ◽  
Lígia Basto ◽  
Ana Areia ◽  
Sofia Franco ◽  
Maria Malheiro ◽  
...  

Purpose To evaluate maternal-fetal surveillance and follow-up of infants at risk for congenital syphilis (CS). Methods Retrospective cohort study in a Portuguese Tertiary Referral Hospital. The main inclusion criterion was a positive syphilis serology. The study included all pregnant women that delivered in our hospital between January 2004 and December 2013. The neonates were classified according to their probability of infection based on the Centers for Disease Control and Prevention guidelines. Results Among the 27 pregnancies at risk for CS, 48.2% (n = 13) of the women had a diagnosis during the 1st trimester, and the median gestational age at the end of the treatment was 28 weeks. Inadequate treatment was noted in 44.4% (n = 12) of the women. Adverse pregnancy outcomes were observed in 30.8% of the cases (n = 8), 5 of which had been adequately treated. We found 2 (7.7%) cases with “proven or highly probable CS,” 10 (38.5%) with “possible CS,” 12 (46.1%) with “less likely CS,” and 2 (7.7%) with “unlikely CS.” Among the infants, the treatment was successful, except for 1 neurosyphilis case. Conclusion This study highlights many of the difficulties/concerns encountered in the maternal-neonatal management of syphilis. We highlight the importance of assuring the early detection of the infection as a way of guaranteeing the timely treatment, as well as a good compliance to the treatment and follow-up through a more efficient pregnant women surveillance network.


BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e020199 ◽  
Author(s):  
Marije van der Hulst ◽  
Marjolein W de Groot ◽  
Johanna P de Graaf ◽  
Rianne Kok ◽  
Peter Prinzie ◽  
...  

IntroductionSocial vulnerability is known to be related to ill health. When a pregnant woman is socially vulnerable, the ill health does not only affect herself, but also the health and development of her (unborn) child. To optimise care for highly vulnerable pregnant women, in Rotterdam, a holistic programme was developed in close collaboration between the university hospital, the local government and a non-profit organisation. This programme aims to organise social and medical care from pregnancy until the second birthday of the child, while targeting adult and child issues simultaneously. In 2014, a pilot in the municipality of Rotterdam demonstrated the significance of this holistic approach for highly vulnerable pregnant women. In the ‘Mothers of Rotterdam’ study, we aim to prospectively evaluate the effectiveness of the holistic approach, referred to as targeted social care.Methods and analysisThe Mothers of Rotterdam study is a pragmatic prospective cohort study planning to include 1200 highly vulnerable pregnant women for the comparison between targeted social care and care as usual. Effectiveness will be compared on the following outcomes: (1) child development (does the child show adaptive development at year 1?) and (2) maternal mental health (is maternal distress reduced at the end of the social care programme?). Propensity scores will be used to correct for baseline differences between both social care programmes.Ethics and disseminationThe prospective cohort study was approved by the Erasmus Medical Centre Ethics Committee (ref. no. MEC-2016–012) and the first results of the study are expected to be available in the second half of 2019 through publication in peer-reviewed international journals.Trial registration numberNTR6271; Pre-results.


BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e044242
Author(s):  
Frederique Jacquerioz ◽  
Stéphanie Baggio ◽  
Angele Gayet-Ageron ◽  
François Chappuis ◽  
Laurent Getaz ◽  
...  

ObjectivesTo develop and validate a rule-out prediction model for the risk of hospitalisation among patients with SARS-CoV-2 infection in the ambulatory setting to derive a simple score to determine outpatient follow-up.DesignProspective cohort study.SettingSwiss university hospital.Participants1459 individuals with a positive result for SARS-CoV-2 infection between 2 March and 23 April 2020.MethodsWe applied the rule of 10 events per variable to construct our multivariable model and included a maximum of eight covariates. We assessed the model performance in terms of discrimination and calibration and performed internal validation to estimate the statistical optimism of the final model. The final prediction model included age, fever, dyspnoea, hypertension and chronic respiratory disease. To develop the OUTCoV score, we assigned points for each predictor that were proportional to the coefficients of the regression equation. Sensitivity, specificity, positive and negative likelihood ratios were estimated, including positive and negative predictive values in different thresholds.Main outcome measureThe primary outcome was COVID-19-related hospitalisation.ResultsThe OUTCoV score ranged from 0 to 7.5 points. The two threshold parameters with optimal rule-out and rule-in characteristics for the risk of hospitalisation were 3 and 5.5, respectively. Outpatients with a score <3 (997/1459; 68.3%) had no follow-up as at low risk of hospitalisation (1.8%; 95% CI 1.1 to 2.8). For a score ≥5.5 (20/1459; 1.4%), the hospitalisation risk was higher (30%; 95% CI 11.9 to 54.3).ConclusionsThe OUTCoV score allows to rule out two-thirds of outpatients with SARS-CoV-2 infection presenting a low hospitalisation risk and to identify those at high risk that require careful follow-up to assess the need for hospitalisation. The model provides a simple decision-making tool for an effective allocation of resources to maintain quality care for outpatient populations.


2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Iveta Nemcova ◽  
Jiri Pasta ◽  
Katerina Hladikova ◽  
Martin Komarc ◽  
Darina Pospisilova ◽  
...  

Purpose. To evaluate a 12-year follow-up of myopic patients after iris-fixated phakic intraocular lenses (IF pIOLs) implantation. Setting. Ophthalmology Department, Military University Hospital in Prague (Czech Republic). Design. Single-center retrospective cohort study. Methods. We describe the results of a cohort study that included 85 eyes of 46 myopic patients who underwent implantation of Verisyse myopia, Veriflex, and Verisyse myopia toric (all Abbott Medical Optics, Inc.) intraocular lenses. Refractive functions and adverse events were assessed preoperatively, at 6 months, and 1, 2, 5, and 12 years after IF pIOL implantation. Results. Mean spherical equivalent was measured as −9.37 ± 2.87 D, 0.14 ± 0.61 D, and −0.42 ± 1.08 D, preoperatively, at 6 months and 12 years postoperatively, respectively. There was a significant reduction in the cylinder after surgery. At 12 years postoperatively, 90% of eyes had uncorrected distance visual acuity (UDVA) of 20/40 and 64% of 20/20. The safety index was 1.10 for the whole postoperative follow-up period. We found cataract formation in 3 eyes (3.5%). The endothelial cells loss (EC loss) directly caused by IF pIOL implantation was 6.0%, 8.10%, 12.8%, and 11.9%, at 1, 2, 5, and 12 years, respectively. In our cohort, 95% of eyes lost a higher percentage of EC than would be expected from a physiological loss at 12 years postoperatively. We found a significant negative interaction between preoperative pachymetry and EC loss, indicating that the lower pachymetry leads to a faster decline in endothelial cells density (ECD). IF pIOL re-enclavation was found in 28% of eyes. 7% of subluxations were caused by trauma. The mean time of nontraumatic re-enclavation was 6 years postoperatively. Conclusions. The study confirmed the advantages of IF pIOL implantation due to rapid visual recovery and stable visual function over the 12-year follow-up and also showed the influence of lower corneal pachymetry regarding EC loss.


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