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BACKGROUND: Recently, validated risk models predicting adverse obstetric outcomes combined with risk-dependent care paths have been made available for early antenatal care in the southeastern part of the Netherlands. This study will evaluate implementation progress and impact of the new approach in obstetric care. OBJECTIVE: The objective of this paper is to describe the design of a study evaluating the impact of implementing risk-dependent care. Validated first-trimester prediction models are embedded in daily clinical practice and combined with risk-dependent obstetric care paths. METHODS: A multicenter prospective cohort study consisting of women who receive risk-dependent care is being performed from April 2017 to April 2018 (Expect Study II). Obstetric risk profiles will be calculated using a Web-based tool, the Expect prediction tool. The primary outcomes are the adherence of health care professionals and compliance of women. Secondary outcomes are patient satisfaction and cost-effectiveness. Outcome measures will be established using Web-based questionnaires. The secondary outcomes of the risk-dependent care cohort (Expect II) will be compared with the outcomes of a similar prospective cohort (Expect I). Women of this similar cohort received former care-as-usual and were prospectively included between July 1, 2013 and December 31, 2015 (Expect I). RESULTS: Currently, women are being recruited for the Expect Study II, and a total of 300 women are enrolled. CONCLUSIONS: This study will provide information about the implementation and impact of a new approach in obstetric care using prediction models and risk-dependent obstetric care paths. TRIAL REGISTRATION: Netherlands Trial Register NTR4143; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4143 (Archived by WebCite at http://www.webcitation.org/6t8ijtpd9).
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BACKGROUND: A number of first-trimester prediction models addressing important obstetric outcomes have been published. However, most models have not been externally validated. External validation is essential before implementing a prediction model in clinical practice. OBJECTIVE: The objective of this paper is to describe the design of a study to externally validate existing first trimester obstetric prediction models, based upon maternal characteristics and standard measurements (eg, blood pressure), for the risk of pre-eclampsia (PE), gestational diabetes mellitus (GDM), spontaneous preterm birth (PTB), small-for-gestational-age (SGA) infants, and large-for-gestational-age (LGA) infants among Dutch pregnant women (Expect Study I). The results of a pilot study on the feasibility and acceptability of the recruitment process and the comprehensibility of the Pregnancy Questionnaire 1 are also reported. METHODS: A multicenter prospective cohort study was performed in The Netherlands between July 1, 2013 and December 31, 2015. First trimester obstetric prediction models were systematically selected from the literature. Predictor variables were measured by the Web-based Pregnancy Questionnaire 1 and pregnancy outcomes were established using the Postpartum Questionnaire 1 and medical records. Information about maternal health-related quality of life, costs, and satisfaction with Dutch obstetric care was collected from a subsample of women. A pilot study was carried out before the official start of inclusion. External validity of the models will be evaluated by assessing discrimination and calibration. RESULTS: Based on the pilot study, minor improvements were made to the recruitment process and online Pregnancy Questionnaire 1. The validation cohort consists of 2614 women. Data analysis of the external validation study is in progress. CONCLUSIONS: This study will offer insight into the generalizability of existing, non-invasive first trimester prediction models for various obstetric outcomes in a Dutch obstetric population. An impact study for the evaluation of the best obstetric prediction models in the Dutch setting with respect to their effect on clinical outcomes, costs, and quality of life-Expect Study II-is being planned. TRIAL REGISTRATION: Netherlands Trial Registry (NTR): NTR4143; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4143 (Archived by WebCite at http://www.webcitation.org/6t8ijtpd9).
RESUMO
BACKGROUND: Preterm labour is the main cause of perinatal morbidity and mortality in the Western world. At present, there is evidence that tocolysis for 48 hours is useful in women with threatened preterm labour at least before 32 weeks. This allows transfer of the patient to a perinatal centre, and maximizes the effect of corticosteroids for improved neonatal survival. It is questionable whether treatment with tocolytics should be maintained after 48 hours. METHODS/DESIGN: The APOSTEL II trial is a multicentre placebo-controlled study. Pregnant women admitted for threatened preterm labour who have been treated with 48 hours corticosteroids and tocolysis will be eligible to participate in the trial between 26+0 and 32+2 weeks gestational age. They will be randomly allocated to nifedipine (intervention) or placebo (control) for twelve days or until delivery, whatever comes first.Primary outcome is a composite of perinatal death, and severe neonatal morbidity up to evaluation at 6 months after birth. Secondary outcomes are gestational age at delivery, number of days in neonatal intensive care and total days of the first 6 months out of hospital. In addition a cost-effectiveness analysis will be performed. Analysis will be by intention to treat. The power calculation is based on an expected 11% difference in adverse neonatal outcome. This implies that 406 women have to be randomised (two sided test, beta 0.2 at alpha 0.05). DISCUSSION: This trial will provide evidence as to whether maintenance tocolysis reduces severe perinatal morbidity and mortality in women with threatened preterm labour before 32 weeks. CLINICAL TRIAL REGISTRATION: http://www.trialregister.nl, NTR 1336, date of registration: June 3rd 2008.