21 research outputs found

    Prognosis in unexplained recurrent pregnancy loss: a systematic review and quality assessment of current clinical prediction models

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    Objective: To identify models predicting live birth or ongoing pregnancy in couples with unexplained recurrent pregnancy loss (RPL) and evaluate the risk of bias, performance, generalizability, and applicability of these models. Evidence Review: A systematic literature search was performed in PubMed, Embase, Web of Science, and Cochrane Library until December 2020. Studies were eligible for inclusion if they were original studies predicting pregnancy outcome in patients with unexplained RPL and presented a tool that allowed for individual predictions. The risk of bias and applicability of the studies were assessed using the Prediction model Risk of Bias Assessment Tool. The Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis statement was used to assess reporting quality. Results: The search yielded 1,170 unique articles that were screened on the basis of the title and abstract. Seven studies were included: 1 prospective cohort study and 6 retrospective cohort studies. The recommended steps for the development of a prediction model were not followed by any of the studies, although 6 were published before the Prediction model Risk of Bias Assessment Tool and Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis guidelines. The included studies had a high risk of bias and were not externally validated. Conclusion: International guidelines recommend supportive care programs with prognostic counseling for couples with unexplained RPL. This information manages the expectations of couples and improves their ability to make an informed decision regarding further pregnancy attempts. On the basis of the results of this study, we cannot recommend the use of any of the studied prediction models in clinical practice to prevent overestimation of chances and false belief

    Development of the OPAL prediction model for prediction of live birth in couples with recurrent pregnancy loss: protocol for a prospective and retrospective cohort study in the Netherlands

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    INTRODUCTION: Recurrent pregnancy loss (RPL) is defined as the loss of two or more conceptions before 24 weeks gestation. Despite extensive diagnostic workup, in only 25%-40% an underlying cause is identified. Several factors may increase the risk for miscarriage, but the chance of a successful pregnancy is still high. Prognostic counselling plays a significant role in supportive care. The main limitation in current prediction models is the lack of a sufficiently large cohort, adjustment for relevant risk factors, and separation between cumulative live birth rate and the success chance in the next conception. In this project, we aim to make an individualised prognosis for the future chance of pregnancy success, which could lead to improved well-being and the ability managing reproductive choices. METHODS AND ANALYSIS: In this multicentre study, we will include both a prospective and a retrospective cohort of at least 931 and 1000 couples with RPL, respectively. Couples who have visited one of the three participating university hospitals in the Netherlands for intake are eligible for the study participation, with a follow-up duration of 5 years. General medical and obstetric history and reports of pregnancies after the initial consultation will be collected. Multiple imputation will be performed to cope for missing data. A Cox proportional hazards model for time to pregnancy will be developed to estimate the cumulative chance of a live birth within 3 years after intake. To dynamically estimate the chance of an ongoing pregnancy, given the outcome of earlier pregnancies after intake, a logistic regression model will be developed. ETHICS AND DISSEMINATION: The Medical Ethical Research Committee of the Leiden University Medical Center approved this study protocol (N22.025). There are no risks or burden associated with this study. Participant written informed consent is required for both cohorts. Findings will be published in peer-reviewed journals and presentations at international conferences. TRIAL REGISTRATION NUMBER: NCT05167812

    Depression, anxiety, and post-traumatic stress disorder symptoms after hyperemesis gravidarum: a prospective cohort study

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    Objective: To determine the prevalence of depression, anxiety, and posttraumatic stress disorder (PTSD) years after hyperemesis gravidarum (HG) and its association with HG severity. Material and methods: This prospective cohort study consisted of a follow-up of 215 women admitted for HG, who were eligible to participate in a randomized controlled trial and either declined or agreed to be randomized between 2013 and 2016 in 19 hospitals in the Netherlands. Participants completed the Hospital Anxiety and Depression Scale (HADS) six weeks postpartum and during follow-up and the PTSD checklist for DSM-5 (PCL-5) during follow-up. An anxiety or depression score ≥8 is indicative of an anxiety or depression disorder and a PCL-5 ≥ 31 indicative of PTSD. Measures of HG severity were symptom severity (PUQE-24: Pregnancy Unique Quantification of Emesis), weight change, duration of admissions, readmissions, and admissions after the first trimester. Results: About 54/215 participants completed the HADS six weeks postpartum and 73/215 participants completed the follow-up questionnaire, on average 4.5 years later. Six weeks postpartum, 13 participants (24.1%) had an anxiety score ≥8 and 11 participants (20.4%) a depression score ≥8. During follow-up, 29 participants (39.7%) had an anxiety score ≥8, 20 participants (27.4%) a depression score ≥8, and 16 participants (21.9%) a PCL-5 ≥ 31. Multivariable logistic regression analysis showed that for every additional point of the mean PUQE-24 three weeks after inclusion, the likelihood of having an anxiety score ≥8 and PCL-5 ≥ 31 at follow-up increased with OR 1.41 (95% CI: 1.10;1.79) and OR 1.49 (95% CI: 1.06;2.10) respectively. Conclusion: Depression, anxiety, and PTSD symptoms are common years after HG occurred
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