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
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
Wit, L. de; Rademaker, D.; Voormolen, D.N.; Akerboom, B.M.C.; Kiewiet-Kemper, R.M.; Soeters, M.R.; ... ; Rijn, B.B. van 2019
Introduction In women with gestational diabetes mellitus (GDM) requiring pharmacotherapy, insulin was the established first-line treatment. More recently, oral glucose lowering drugs (OGLDs) have... Show moreIntroduction In women with gestational diabetes mellitus (GDM) requiring pharmacotherapy, insulin was the established first-line treatment. More recently, oral glucose lowering drugs (OGLDs) have gained popularity as a patient-friendly, less expensive and safe alternative. Monotherapy with metformin or glibenclamide (glyburide) is incorporated in several international guidelines. In women who do not reach sufficient glucose control with OGLD monotherapy, usually insulin is added, either with or without continuation of OGLDs. No reliable data from clinical trials, however, are available on the effectiveness of a treatment strategy using all three agents, metformin, glibenclamide and insulin, in a stepwise approach, compared with insulin-only therapy for improving pregnancy outcomes. In this trial, we aim to assess the clinical effectiveness, cost-effectiveness and patient experience of a stepwise combined OGLD treatment protocol, compared with conventional insulin-based therapy for GDM.Methods The SUGAR-DIP trial is an open-label, multicentre randomised controlled non-inferiority trial. Participants are women with GDM who do not reach target glycaemic control with modification of diet, between 16 and 34 weeks of gestation. Participants will be randomised to either treatment with OGLDs, starting with metformin and supplemented as needed with glibenclamide, or randomised to treatment with insulin. In women who do not reach target glycaemic control with combined metformin and glibenclamide, glibenclamide will be substituted with insulin, while continuing metformin. The primary outcome will be the incidence of large-for-gestational-age infants (birth weight >90th percentile). Secondary outcome measures are maternal diabetes-related endpoints, obstetric complications, neonatal complications and cost-effectiveness analysis. Outcomes will be analysed according to the intention-to-treat principle.Ethics and dissemination The study protocol was approved by the Ethics Committee of the Utrecht University Medical Centre. Approval by the boards of management for all participating hospitals will be obtained. Trial results will be submitted for publication in peer-reviewed journals.Trial registration number NTR6134; Pre-results. Show less
