Objective: To assess the various factors that influence environmentally sustainable behaviour in gynaecological surgery and examine the differences between gynaecologists and residents.Design: An... Show moreObjective: To assess the various factors that influence environmentally sustainable behaviour in gynaecological surgery and examine the differences between gynaecologists and residents.Design: An interview study.Setting: Academic and non-academic hospitals in the Netherlands.Population: Gynaecologists (n = 10) and residents (n = 6).Methods: Thematic analysis of semi-structured interviews to determine the various factors that influence environmentally sustainable behaviour in gynaecological surgery and to examine the differences between gynaecologists and residents. By using the Desmond framework and the COM-B BCW, both organisational and individual factors related to behaviour were considered.Main outcome measures: Factors that influence environmentally sustainable behaviour.Results: Awareness is increasing but practical knowledge is insufficient. It is crucial to integrate education on the environmental impact of everyday decisions for residents and gynaecologists. Gynaecologists make their own choices but residents' autonomy is limited. There is the necessity to provide environmentally sustainable surgical equipment without compromising other standards. There is a need for a societal change that encourages safe and open communication about environmental sustainability. To transition to environmentally sustainable practices, leadership, time, collaboration with the industry and supportive regulatory changes are essential.Conclusion: This study lays the groundwork for promoting more environmentally sustainable behaviour in gynaecological surgery. The key recommendations, addressing hospital regulations, leadership, policy revisions, collaboration with the industry, guideline development and education, offer practical steps towards a more sustainable healthcare system. Encouraging environmentally sustainable practices should be embraced to enhance the well-being of both our planet and our population, driving us closer to a more environmentally sustainable future in healthcare. Show less
Nieuwenhuizen, K.E. van; Friedericy, H.J.; Linden, S. van der; Jansen, F.W.; Eijk, A.C. van der 2023
ObjectiveTo determine the user experience of wearing comfort of reusable sterile surgical gowns and compare these gowns with conventional disposable surgical gowns.DesignCross-sectional survey... Show moreObjectiveTo determine the user experience of wearing comfort of reusable sterile surgical gowns and compare these gowns with conventional disposable surgical gowns.DesignCross-sectional survey.SettingsAn academic hospital in the Netherlands, population Gynaecologists, surgeons, residents and operating room assistants (n = 80).MethodsQuantitative and qualitative data were obtained via a written questionnaire. Participants provided subjective comments and scored the reusable gown on each individual topic with a score from 1 to 5 (1 = unsatisfactory, 2 = moderate, 3 = good, 4 = very good, 5 = excellent) and compared the reusable gown with the conventional disposable alternative (better, equal or worse).Main outcome measuresWearing comfort: ventilation and temperature regulation, fit and length, functionality, barrier function and ease of use.ResultsThe results of the overall scores of the reusable gown are scored as 'very good' (mean 4.3, SD +/- 0.5) by its users. Regarding comparison of the gowns, more than 79% (lowest score 79%, highest score 95%) of the participants scored the reusable gown equal or higher on six of seven topics. The topic 'ease of use' was scored equal or higher by 59% of the participants. Subjective comments provided information on possible improvements.ConclusionsThe findings of this study demonstrate that there is professional acceptance regarding the utilisation of reusable surgical gowns. To facilitate broader adoption, it is imperative to foster collaboration among suppliers and healthcare institutions. The reusable surgical gown is an environmentally sustainable, safe and comfortable alternative in the operating room. Show less
Van't Oever, R.M.; Zwiers, C.; Haas, M. de; Cessie, S. le; Lopriore, E.; Oepkes, D.; Verweij, E.J.T. 2023
ObjectivePregnant women who received at least one intrauterine transfusion (IUT) for haemolytic disease of the fetus and newborn (HDFN) in the preceding pregnancy are presumed to have a high... Show moreObjectivePregnant women who received at least one intrauterine transfusion (IUT) for haemolytic disease of the fetus and newborn (HDFN) in the preceding pregnancy are presumed to have a high likelihood of requiring IUTs again, often starting at an earlier gestational age. Our aim was to quantify these risks in a large national cohort.DesignRetrospective cohort study of a nationwide Dutch database.SettingThe Netherlands.PopulationAll women treated in The Netherlands with IUTs for Rhesus D (RhD)- or Kell-mediated HDFN between 1999 and 2017 and their follow-up pregnancies were included. Pregnancies with an antigen-negative fetus were excluded.MethodsElectronic patient files were searched for the number and gestational age of each IUT, and analysed using descriptive statistics and linear regression.Main outcome measuresPercentage of women requiring one or more IUTs again in the subsequent pregnancy, and gestational age at first IUT in both pregnancies.ResultsOf the 321 women in our study population, 21% (69) had a subsequent ongoing pregnancy at risk. IUTs were administered in 86% (59/69) of cases. In subsequent pregnancies, the median gestational age at first IUT was 3 weeks earlier (interquartile range -6.8 to 0.4) than in the preceding pregnancy.ConclusionsOur study shows that pregnant women with a history of IUTs in the previous pregnancy are highly likely to require IUTs again, and on average 3 weeks earlier. Clinicians need to be aware of these risks and ensure timely referral, and close surveillance from early pregnancy onwards. Additionally, for women with a history of IUT and their caregivers, this information is essential to enable adequate preconception counselling. Show less
Objective: To study the impact of premenopausal risk-reducing salpingo-oophorectomy (RRSO), compared with postmenopausal RRSO, on urinary incontinence (UI) >= 10 years later.Design: Cross... Show moreObjective: To study the impact of premenopausal risk-reducing salpingo-oophorectomy (RRSO), compared with postmenopausal RRSO, on urinary incontinence (UI) >= 10 years later.Design: Cross-sectional study, nested in a nationwide cohort.Setting: Multicentre in the Netherlands.Population: 750 women (68% BRCA1/2 pathogenic variant carriers) who underwent either premenopausal RRSO (<= 45 years, n = 496) or postmenopausal RRSO (>= 54 years, n = 254). All participants were >= 55 years at the time of the study.Methods: Urinary incontinence was assessed by the urinary distress inventory-6 (UDI-6); a score >= 33.3 indicated symptomatic UI. The incontinence impact questionnaire short form (IIQ-SF) was used to assess the impact on women's health-related quality of life (HR-QoL). Differences between groups were analysed using regression analyses adjusting for current age and other confounders.Main outcome measures: Differences in UDI-6 scores and IIQ-SF scores between women with a premenopausal and a postmenopausal RRSO.Results: Women in the premenopausal RRSO group had slightly higher UDI-6 scores compared with women in the postmenopausal RRSO group (P = 0.053), and their risk of symptomatic UI was non-significantly increased (odds ratio [OR] 2.1, 95% confidence interval [95% CI] 0.93-4.78). A premenopausal RRSO was associated with a higher risk of stress UI (OR 3.5, 95% CI 1.2-10.0) but not with urge UI. The proportions of women with a significant impact of UI on HR-QoL were similar in the premenopausal and postmenopausal RRSO groups (10.4% and 13.0%, respectively; P = 0.46).Conclusions: More than 15 years after premenopausal RRSO, there were no significant differences in overall symptomatic UI between women with a premenopausal and those with a postmenopausal RRSO. Show less
Schreurs, A.M.F.; Overtoom, E.M.; Boer, M.A. de; Houwen, L.E.E. van der; Lier, M.C.I.; Akker, T. van den; ... ; Mijatovic, V. 2023
Objective: To evaluate the incidence, diagnostic management strategies and clinical outcomes of women with spontaneous haemoperitoneum in pregnancy (SHiP) and reassess the definition of SHiP.Design... Show moreObjective: To evaluate the incidence, diagnostic management strategies and clinical outcomes of women with spontaneous haemoperitoneum in pregnancy (SHiP) and reassess the definition of SHiP.Design: A population-based cohort study using the Netherlands Obstetric Surveillance System (NethOSS).Setting: Nationwide, the Netherlands.Population: All pregnant women between April 2016 and April 2018.Methods: This is a case study of SHiP using the monthly registry reports of NethOSS. Complete anonymised case files were obtained. A newly introduced online Delphi audit system (DAS) was used to evaluate each case, to make recommendations on improving the management of SHiP and to propose a new definition of SHiP.Main outcome measures: Incidence and outcomes, lessons learned about clinical management and the critical appraisal of the current definition of SHiP.Results: In total, 24 cases were reported. After a Delphi procedure, 14 cases were classified as SHiP. The nationwide incidence was 4.9 per 100 000 births. Endometriosis and conceiving after artificial reproductive techniques were identified as risk factors. No maternal and three perinatal deaths occurred. Based on the DAS, adequate imaging of free intra-abdominal fluid, and identifying and treating women with signs of hypovolemic shock could improve the early detection and management of SHiP. A revised definition of SHiP was proposed, excluding the need for surgical or radiological intervention.Conclusions: SHiP is a rare and easily misdiagnosed condition that is associated with high perinatal mortality. To improve care, better awareness among healthcare workers is needed. The DAS is a sufficient tool to audit maternal morbidity and mortality. Show less
Vries, P.L.M. de; Deneux-Tharaux, C.; Baud, D.; Chen, K.K.; Donati, S.; Goffinet, F.; ... ; Akker, T. van den 2023
Objective: To compare guidelines from eight high-income countries on prevention and management of postpartum haemorrhage (PPH), with a particular focus on severe PPH.Design: Comparative study... Show moreObjective: To compare guidelines from eight high-income countries on prevention and management of postpartum haemorrhage (PPH), with a particular focus on severe PPH.Design: Comparative study.Setting: High-resource countries.Population: Women with PPH.Methods: Systematic comparison of guidance on PPH from eight high-income countries.Main outcome measures: Definition of PPH, prophylactic management, measurement of blood loss, initial PPH-management, second-line uterotonics, non-pharmacological management, resuscitation/transfusion management, organisation of care, quality/methodological rigour.Conclusions: Our study highlights areas where strong evidence is lacking. There is need for a universal definition of (severe) PPH. Consensus is required on how and when to quantify blood loss to identify PPH promptly. Future research may focus on timing and sequence of second-line uterotonics and non-pharmacological interventions and how these impact maternal outcome. Until more data are available, different transfusion strategies will be applied. The use of clear transfusion-protocols are nonetheless recommended to reduce delays in initiation. There is a need for a collaborative effort to develop standardised, evidence-based PPH guidelines.Results: Definitions of (severe) PPH varied as to the applied cut-off of blood loss and incorporation of clinical parameters. Dose and mode of administration of prophylactic uterotonics and methods of blood loss measurement were heterogeneous. Recommendations on second-line uterotonics differed as to type and dose. Obstetric management diverged particularly regarding procedures for uterine atony. Recommendations on transfusion approaches varied with different thresholds for blood transfusion and supplementation of haemostatic agents. Quality of guidelines varied considerably. Show less
Objective: Analysis of atypical cases of uterine rupture, namely, uterine rupture occurring in unscarred, preterm or prelabour uteri.Design: Descriptive multi-country population-based study.Setting... Show moreObjective: Analysis of atypical cases of uterine rupture, namely, uterine rupture occurring in unscarred, preterm or prelabour uteri.Design: Descriptive multi-country population-based study.Setting: Ten high-income countries within the International Network of Obstetric Survey Systems.Population: Women with unscarred, preterm or prelabour ruptured uteri.Methods: We merged prospectively collected individual patient data in ten population-based studies of women with complete uterine rupture. In this analysis, we focused on women with uterine rupture of unscarred, preterm or prelabour ruptured uteri.Main Outcome MeasuresIncidence, women's characteristics, presentation and maternal and perinatal outcome.Results: We identified 357 atypical uterine ruptures in 3 064 923 women giving birth. Estimated incidence was 0.2 per 10 000 women (95% CI 0.2-0.3) in the unscarred uteri, 0.5 (95% CI 0.5-0.6) in the preterm uteri, 0.7 (95% CI 0.6-0.8) in the prelabour uteri, and 0.5 (95% CI 0.4-0.5) in the group with no previous caesarean. Atypical uterine rupture resulted in peripartum hysterectomy in 66 women (18.5%, 95% CI 14.3-23.5%), three maternal deaths (0.84%, 95% CI 0.17-2.5%) and perinatal death in 62 infants (19.7%, 95% CI 15.1-25.3%).Conclusions: Uterine rupture in preterm, prelabour or unscarred uteri are extremely uncommon but were associated with severe maternal and perinatal outcome. We found a mix of risk factors in unscarred uteri, most preterm uterine ruptures occurred in caesarean-scarred uteri and most prelabour uterine ruptures in 'otherwise' scarred uteri. This study may increase awareness among clinicians and raise suspicion of the possibility of uterine rupture under these less expected conditions. Show less
Objective: To examine the effect of a premenopausal risk-reducing salpingo-oophorectomy (RRSO) in women at increased risk of ovarian cancer on objective and subjective cognition at least 10 years... Show moreObjective: To examine the effect of a premenopausal risk-reducing salpingo-oophorectomy (RRSO) in women at increased risk of ovarian cancer on objective and subjective cognition at least 10 years after RRSO.Design: A cross-sectional study with prospective follow-up, nested in a nationwide cohort.Setting: Multicentre in the Netherlands.Population or Sample: 641 women (66% BRCA1/2 pathogenic variant carriers) who underwent either a premenopausal RRSO <= age 45 (n = 436) or a postmenopausal RRSO >= age 54 (n = 205). All participants were older than 55 years at recruitment.Methods: Participants completed an online cognitive test battery and a questionnaire on subjective cognition. We used multivariable regression analyses, adjusting for age, education, breast cancer, hormone replacement therapy, cardiovascular risk factors and depression.Main Outcome Measures: The influence of RRSO on objective and subjective cognition of women with a premenopausal RRSO compared with women with a postmenopausal RRSO.Results: After adjustment, women with a premenopausal RRSO (mean time since RRSO 18.2 years) performed similarly on objective cognitive tests compared with women with a postmenopausal RRSO (mean time since RRSO 11.9 years). However, they more frequently reported problems with reasoning (odds ratio [OR] 1.8, 95% confidence interval [95% CI] 1.1-3.1) and multitasking (OR 1.9, 95% CI 1.1-3.4) than women with a postmenopausal RRSO. This difference between groups disappeared in an analysis restricted to women of comparable ages (60-70 years).Conclusions: Reassuringly, approximately 18 years after RRSO, we found no association between premenopausal RRSO and objective cognition. Show less
Thierens, S.; Binsbergen, A. van; Nolens, B.; Akker, T. van den; Bloemenkamp, K.; Rijken, M.J. 2023
Background: Prolonged second stage of labour is an important cause of maternal and perinatal morbidity and mortality. Vacuum extraction (VE) and second- stage caesarean section (SSCS) are the most... Show moreBackground: Prolonged second stage of labour is an important cause of maternal and perinatal morbidity and mortality. Vacuum extraction (VE) and second- stage caesarean section (SSCS) are the most commonly performed obstetric interventions, but the procedure chosen varies widely globally. Objectives: To compare maternal and perinatal morbidity, mortality and other ad-verse outcomes after VE versus SSCS.Search Strategy: A systematic search was conducted in PubMed, Cochrane and EMBASE. Studies were critically appraised using the Newcastle- Ottawa scale. Selection Criteria: All artictles including women in second stage of labour, giving birth by vacuum extraction or cesarean section and registering at least one perinatal or maternal outcome were selected.Data Collection and Analysis: The chi-square test, Fisher exact's test and binary logistic regression were used and various adverse outcome scores were calculated to evaluate maternal and perinatal outcomes.Main Results: Fifteen articles were included, providing the outcomes for a total of 20 051 births by SSCS and 32 823 births by VE. All five maternal deaths resulted from complications of anaesthesia during SSCS. In total, 133 perinatal deaths occurred in all studies combined: 92/20 051 (0.45%) in the SSCS group and 41/32 823 (0.12%) in the VE group. In studies with more than one perinatal death, both conducted in low-resource settings, more perinatal deaths occurred during the decision- to- birth interval in the SSCS group than in the VE group (5.5% vs 1.4%, OR 4.00, 95% CI 1.17- 13.70; 11% vs 8.4%, OR 1.39, 95% CI 0.85- 2.26). All other adverse maternal and perinatal outcomes showed no statistically significant differences.Conclusions: Vacuum extraction should be the recommended mode of birth, both in high-income countries and in low-and middle-income countries, to prevent un-necessary SSCS and to reduce perinatal and maternal deaths when safe anaesthesia and surgery is not immediately available. Show less
Aliasi, M.; Snoep, M.C.; Geloven, N. van; Haak, M.C. 2022
Background Birthweight (BW) is an important prognostic factor in newborns with congenital heart defects (CHD). Objectives To give an overview of the literature on BW z-score in children with... Show moreBackground Birthweight (BW) is an important prognostic factor in newborns with congenital heart defects (CHD). Objectives To give an overview of the literature on BW z-score in children with isolated CHD. Search strategy A systematic search was performed on isolated CHD and BW in PubMed, Embase, Web of Science, COCHRANE Library and Emcare. Selection criteria Neonates with isolated CHD were included if a BW percentile, BW z-score or % small-or-gestational age (SGA) was reported. Data collection and analysis BW z-score and percentage SGA were pooled with random-effect meta-analysis. Quality and risk of bias were assessed using the modified Newcastle Ottawa Scale. Main results Twenty-three articles (27 893 cases) were included. BW z-scores were retrieved from 11 articles, resulting in a pooled z-score of -0.20 (95% CI -0.50 to 0.11). The overall pooled prevalence of SGA <10th percentile was 16.0% (95% CI 11.4-20.5; 14 studies). Subgroup analysis of major CHD showed similar results (BW z-score -0.23 and percentage SGA 16.2%). Conclusions Overall BW in isolated CHD is within range of normality but impaired, with a 1.6-fold higher risk of SGA, irrespective of the type of CHD (major CHD vs all CHD combined). Our findings underline the association between CHD and BW. The use of BW z-scores provides insight into growth of all fetuses with CHD. Show less
Slootweg, Y.M.; Zwiers, C.; Koelewijn, J.M.; Schoot, E. van der; Oepkes, D.; Kamp, I.L. van; Haas, M. de 2022
Objective To evaluate which risk factors for RhD immunisation remain, despite adequate routine antenatal and postnatal RhIg prophylaxis (1000 IU RhIg) and additional administration of RhIg. The... Show moreObjective To evaluate which risk factors for RhD immunisation remain, despite adequate routine antenatal and postnatal RhIg prophylaxis (1000 IU RhIg) and additional administration of RhIg. The second objective was assessment of the current prevalence of RhD immunisations. Design Prospective cohort study. Setting The Netherlands. Population Two-year nationwide cohort of alloimmunised RhD-negative women. Methods RhD-negative women in their first RhD immunised pregnancy were included for risk factor analysis. We compared risk factors for RhD immunisation, occurring either in the previous non-immunised pregnancy or in the index pregnancy, with national population data derived from the Dutch perinatal registration (Perined). Results In the 2-year cohort, data from 193 women were eligible for analysis. Significant risk factors in women previously experiencing a pregnancy of an RhD-positive child (n = 113) were: caesarean section (CS) (OR 1.7, 95% CI 1.1-2.6), perinatal death (OR 3.5, 95% CI 1.1-10.9), gestational age >42 weeks (OR 6.1, 95% CI 2.2-16.6), postnatal bleeding (>1000 ml) (OR 2.0, 95% CI 1.1-3.6), manual removal of the placenta (MRP) (OR 4.3, 95% CI 2.0-9.3); these factors often occurred in combination. The miscarriage rate was significantly higher than in the Dutch population (35% versus 12.-5%, P < 0.001). Conclusion Complicated deliveries, including cases of major bleeding and surgical interventions (CS, MRP), must be recognised as a risk factor, requiring estimation of fetomaternal haemorrhage volume and adjustment of RhIg dosing. The higher miscarriage rate suggests that existing RhIg protocols need adjustment or better compliance. Show less
Metzemaekers, J.; Akker-van Marle, M.E. van den; Sampat, J.; Smeets, M.J.G.H.; English, J.; Thijs, E.; ... ; Essers, B. 2021
Objective To study the preferences of women with deep endometriosis (DE) with bowel involvement when they have to choose between conservative (medication) or surgical treatment. Design Labelled... Show moreObjective To study the preferences of women with deep endometriosis (DE) with bowel involvement when they have to choose between conservative (medication) or surgical treatment. Design Labelled discrete choice experiment (DCE). Setting Dutch academic and non-academic hospitals and online recruitment. Population or Sample A total of 169 women diagnosed with DE of the bowel. Methods Baseline characteristics and the fear of surgery were collected. Women were asked to rank attributes and choose between hypothetical conservative or surgical treatment in different choice sets (scenarios). Each choice set offered different levels of all treatment attributes. Data were analysed by using multinomial logistic regression. Main Outcome Measures The following attributes - effect on/risk of pain, fatigue, pregnancy, endometriosis lesions, mood swings, osteoporosis, temporary stoma and permanent intestinal symptoms - were used in this DCE. Results In the ranking, osteoporosis was ranked with low importance, whereas in the DCE, a lower chance of osteoporosis was one of the most important drivers when choosing a conservative treatment. Women with previous surgery showed less fear of surgery compared with women without surgery. Low anterior resection syndrome was almost equally important for patients as the chance of pain reduction. Pain reduction had higher importance than improving fertility chances, even in women with desire for a future child. Conclusions The risk of developing low anterior resection syndrome as a result of treatment is almost equally important as the reduction of pain symptoms. Women with previous surgery experience less fear of surgery compared with women without a surgical history. Tweetable Abstract First discrete choice experiment in patients with deep endometriosis. Show less
Objective To perform a temporal and geographical validation of a prognostic model, considered of highest methodological quality in a recently published systematic review, for predicting survival in... Show moreObjective To perform a temporal and geographical validation of a prognostic model, considered of highest methodological quality in a recently published systematic review, for predicting survival in very preterm infants admitted to the neonatal intensive care unit. The original model was developed in the UK and included gestational age, birthweight and gender. Design External validation study in a population-based cohort. Setting Dutch neonatal wards. Population or sample All admitted white, singleton infants born between 23(+0) and 32(+6) weeks of gestation between 1 January 2015 and 31 December 2019. Additionally, the model's performance was assessed in four populations of admitted infants born between 24(+0) and 31(+6) weeks of gestation: white singletons, non-white singletons, all singletons and all multiples. Methods The original model was applied in all five validation sets. Model performance was assessed in terms of calibration and discrimination and, if indicated, it was updated. Main outcome measures Calibration (calibration-in-the-large and calibration slope) and discrimination (c statistic). Results Out of 6092 infants, 5659 (92.9%) survived. The model showed good external validity as indicated by good discrimination (c statistic 0.82, 95% CI 0.79-0.84) and calibration (calibration-in-the-large 0.003, calibration slope 0.92, 95% CI 0.84-1.00). The model also showed good external validity in the other singleton populations, but required a small intercept update in the multiples population. Conclusions A high-quality prognostic model predicting survival in very preterm infants had good external validity in an independent, nationwide cohort. The accurate performance of the model indicates that after impact assessment, implementation of the model in clinical practice in the neonatal intensive care unit could be considered. Tweetable abstract A high-quality model predicting survival in very preterm infants is externally valid in an independent cohort. Show less
Overtoom, E.M.; Rosman, A.N.; Zwart, J.J.; Vogelvang, T.E.; Schaap, T.P.; Akker, T. van den; Bloemenkamp, K.W.M. 2021
Objective To describe characteristics, risk factors and maternal, obstetric and neonatal outcomes of pregnant women infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).... Show moreObjective To describe characteristics, risk factors and maternal, obstetric and neonatal outcomes of pregnant women infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Design Multi-centre prospective population-based cohort study. Setting Nationwide study in the Netherlands. Population Pregnant women with confirmed SARS-CoV-2 infection admitted to hospital or in home-isolation: 1 March 2020 to 31 August 2020. Methods Pregnant women with positive polymerase chain reaction or antibody tests were registered using the Netherlands Obstetrics Surveillance System (NethOSS). (Selective) testing occurred according to national guidelines. Data from the national birth registry (pregnant pre-coronavirus disease 2019 [COVID-19] cohort) and an age-matched cohort of COVID-19-positive women (National Institute for Public Health and the Environment; fertile age COVID-19 cohort) were used as reference. Main outcome measures Incidence of SARS-CoV-2 infection in pregnant women. Maternal, obstetric and neonatal outcomes including hospital and intensive care admission. Results Of 376 registered pregnant women with confirmed SARS-CoV-2 infection, 20% (74/376) were admitted to hospital, of whom 84% (62/74) were due to SARS-CoV-2; 10% (6/62) were admitted to intensive care and 15% (9/62) to obstetric high-care units. Risk factors for admission were non-European country of origin (odds ratio [OR] 1.73, 95% CI 1.01-2.96) and being overweight/obese (OR 1.86, 95% CI 1.51-3.20). No maternal or perinatal deaths occurred. Caesarean section after labour-onset was increased (OR 1.58, 95% CI 1.09-2.28). Hospital and intensive care admission were higher compared with the fertile age COVID-19 cohort (OR 6.75, 95% CI 5.18-8.81 and OR 2.52, 95% CI 1.11-5.77, respectively). Conclusions Non-European country of origin and being overweight/obese are risk factors for severe course of SARS-CoV-2 infection in pregnancy, risk of caesarean section and hospital and intensive care unit admission are increased. Tweetable abstract Pregnant women with SARS-CoV-2 in the Netherlands show increased hospital/ICU admission and caesarean section. Show less
Objective To compare the long-term effects of tocolysis with nifedipine or atosiban on child outcome at age 2.5-5.5 years.Design The APOSTEL III trial was a multicentre randomised controlled trial... Show moreObjective To compare the long-term effects of tocolysis with nifedipine or atosiban on child outcome at age 2.5-5.5 years.Design The APOSTEL III trial was a multicentre randomised controlled trial that compared tocolysis with nifedipine or atosiban in 503 women with threatened preterm birth. Neonatal outcomes did not differ between both treatment arms, except for a higher incidence of intubation in the atosiban group.Methods Parents were asked to complete four questionnaires regarding neurodevelopment, executive function, behaviour problems, and general health.Main outcome measures The main long-term outcome measure was a composite of abnormal development at the age of 2.5-5.5 years.Results Of the 426 women eligible for follow-up, 196 (46%) parents returned the questionnaires for 115 children in the nifedipine group and 110 children in the atosiban group. Abnormal development occurred in 32 children (30%) in the nifedipine group and in 38 children (38%) in the atosiban group (OR 0.74, 95% CI 0.41-1.34). The separate outcomes for neurodevelopment, executive function, behaviour, and general health showed no significant differences between the groups. Sensitivity analysis for all children of the APOSTEL III trial, including a comparison of deceased children, resulted in a higher rate of healthy survival in the nifedipine group (64 versus 54%), but there was no significant difference in the overall mortality rate (5.4 versus 2.7%). There were no significant subgroup effects.Conclusion Outcomes on broad child neurodevelopment, executive function, behaviour, and general health were comparable in both groups. Neither nifedipine nor atosiban can be considered as the preferred treatment for women with threatened preterm birth.Tweetable abstract Nifedipine- and atosiban-exposed children had comparable long-term outcomes, including neurodevelopment, executive function, and behaviour. Show less
Objective To assess the effect of transabdominal amnioinfusion or no intervention on long-term outcomes in children born after second-trimester prelabour rupture of the membranes (PROM between 16(... Show moreObjective To assess the effect of transabdominal amnioinfusion or no intervention on long-term outcomes in children born after second-trimester prelabour rupture of the membranes (PROM between 16(+0/7)-24(+0/7) weeks) and oligohydramnios.Population Follow up of infants of women who participated in the randomised controlled trial: PPROMEXIL-III (NTR3492).Methods Surviving infants were invited for neurodevelopmental assessment up to 5 years of corrected age using a Bayley Scales of Infant and Toddler Development or a Wechsler Preschool and Primary Scale of Intelligence. Parents were asked to complete several questionnaires.Main outcome measures Neurodevelopmental outcomes were measured. Mild delay was defined as -1 standard deviation (SD), severe delay as -2 SD. Healthy long-term survival was defined as survival without neurodevelopmental delay or respiratory problems.Results In the amnioinfusion group, 18/28 children (64%) died versus 21/28 (75%) in the no intervention group (relative risk 0.86; 95% confidence interval [CI] 0.60-1.22). Follow-up data were obtained from 14/17 (82%) children (10 amnioinfusion, 4 no intervention). In both groups, 2/28 (7.1%) had a mild neurodevelopmental delay. No severe delay was seen. Healthy long-term survival occurred in 5/28 children (17.9%) after amnioinfusion versus 2/28 (7.1%) after no intervention (odds ratio 2.50; 95% CI 0.53-11.83). When analysing data for all assessed survivors, 10/14 (71.4%) survived without mild neurodevelopmental delay and 7/14 (50%) were classified healthy long-term survivor.Conclusions In this small sample of women suffering second-trimester PROM and oligohydramnios, amnioinfusion did not improve long-term outcomes. Overall, 71% of survivors had no neurodevelopmental delay.Tweetable abstract Healthy long-term survival was comparable for children born after second-trimester PROM and treatment with amnioinfusion or no intervention. Show less
Lommerse, K.; Knight, M.; Nair, M.; Deneux-Tharaux, C.; Akker, T. van den 2019
Objective To assess the cost-effectiveness of treatment with nifedipine compared with atosiban in women with threatened preterm birth. Design An economic analysis alongside a randomised clinical... Show moreObjective To assess the cost-effectiveness of treatment with nifedipine compared with atosiban in women with threatened preterm birth. Design An economic analysis alongside a randomised clinical trial (the APOSTEL III study). Setting Obstetric departments of 12 tertiary hospitals and seven secondary hospitals in the Netherlands and Belgium. Population Women with threatened preterm birth between 25 and 34 weeks of gestation, randomised for tocolysis with either nifedipine or atosiban. Methods We performed an economic analysis from a societal perspective. We estimated costs from randomisation until discharge. Analyses for singleton and multiple pregnancies were performed separately. The robustness of our findings was evaluated in sensitivity analyses. Main outcome measures Mean costs and differences were calculated per woman treated with nifedipine or atosiban. Health outcomes were expressed as the prevalence of a composite of adverse perinatal outcomes. Results Mean costs per patients were significantly lower in the nifedipine group [singleton pregnancies: euro34,897 versus euro43,376, mean difference (MD) -euro8479 [95% confidence interval (CI) -euro14,327 to -euro2016)]; multiple pregnancies: euro90,248 versus euro102,292, MD -euro12,044 (95% CI -euro21,607 to euro -1671). There was a non-significantly higher death rate in the nifedipine group. The difference in costs was mainly driven by a lower neonatal intensive care unit admission (NICU) rate in the nifedipine group. Conclusion Treatment with nifedipine in women with threatened preterm birth results in lower costs when compared with treatment with atosiban. However, the safety of nifedipine warrants further investigation. Tweetable abstract In women with threatened preterm birth, tocolysis using nifedipine results in lower costs when compared with atosiban. Show less
ObjectiveTo investigate the characteristics and outcome of abnormal vaginal bleeding in women receiving edoxaban or warfarin for treatment of venous thromboembolism (VTE).Design and settingPost hoc... Show moreObjectiveTo investigate the characteristics and outcome of abnormal vaginal bleeding in women receiving edoxaban or warfarin for treatment of venous thromboembolism (VTE).Design and settingPost hoc analysis of the Hokusai-VTE study, a multicentre, randomised, double-blind trial comparing edoxaban with warfarin for acute symptomatic VTE.PopulationWomen below 50years receiving edoxaban or warfarin for treatment of VTE.MethodsWe collected data on diagnostic measures, treatment, and clinical outcome of abnormal vaginal bleeding events.Main outcome measuresOccurrence of major and clinically relevant nonmajor (CRNM) abnormal vaginal bleeding events.ResultsIn all, 628 women aged under 50years were treated with edoxaban and 665 with warfarin. The rate of abnormal vaginal bleeding was 15/100 person-years (py) (95%CI 11-19) in women receiving edoxaban and 9/100py (95%CI 6-12) in the warfarin group (hazard ratio: 1.7, 95% CI 1.1-2.5). Major abnormal vaginal bleeding occurred in eight (1.3%) women on edoxaban and in three (0.9%) women receiving warfarin [odds ratio (OR) 2.8; 95% CI 0.8-10.8], and CRNM abnormal vaginal bleeding occurred in 53 (8.4%) women treated with edoxaban and in 37 (5.6%) on warfarin therapy (OR 1.6, 95%CI 1.0-2.4). Over 85% of all vaginal bleeds were characterised by heavy menstrual bleeding. Major bleeds frequently required treatment, and in more than 75% of patients anticoagulant therapy was adjusted. The severity of clinical presentation and course of major and CRNM bleeds was mild in most patients.ConclusionsAbnormal vaginal bleeding occurred more frequently in women treated with edoxaban than with warfarin. Reassuringly, most events could be managed conservatively and had a mild outcome.Tweetable abstractAbnormal vaginal bleeding occurred more frequently in women treated with edoxaban than with warfarin.Tweetable abstract Abnormal vaginal bleeding occurred more frequently in women treated with edoxaban than with warfarin. Show less
Winkelhorst, D.; Murphy, M.; Greinacher, A.; Bakchoul, T.; Massey, E.; Baker, J.; ... ; Ryan, G. 2017
