Objective To evaluate the long‐term outcomes of children born to women with a short cervix and otherwise low risk for preterm birth, after antenatal exposure to vaginal progesterone vs placebo. Methods This was a follow‐up study of the Triple P trial, which randomized 80 low‐risk women with a short cervix (≤ 30 mm) at 18–22 weeks' gestation to progesterone (n = 41) or placebo (n = 39). At 2 years of corrected age, children were invited for a neurodevelopmental assessment, using the Bayley Scales of Infant and Toddler Development, third edition (BSID‐III), and a neurological and physical examination by an assessor blinded to the allocated treatment. Parents filled out the Ages and Stages Questionnaire, the Child Behavior Checklist (CBCL) and a general‐health questionnaire. The main outcome of interest was mean BSID‐III cognitive and motor scores. Additionally, a composite score of mortality and abnormal developmental outcome, including BSID‐III ≤–1 SD, CBCL score in the clinical range and/or parental reported physical problems (at least two operations or at least two hospital admissions in the previous 2 years), was evaluated. Our sample size, dictated by the original sample of the Triple P trial, provided 80% power to detect a mean difference (MD) of 15 points (1 SD) between groups for the BSID‐III tests. Results Of the 80 children born to the randomized women, one in the progesterone group and two in the placebo group died in the neonatal period. Follow‐up data were obtained for 59/77 (77%) children and BSID‐III outcomes in 57 children (n = 28 in the progesterone group and n = 29 in the placebo group) born at a median gestational age of 38 + 6 weeks (interquartile range (IQR), 37 + 3 to 40 + 1 weeks) with a median birth weight of 3240 g (IQR, 2785–3620 g). In the progesterone vs placebo groups, mean BSID‐III cognitive development scores were 101.6 vs 105.0 (MD, –3.4 (95% CI, –9.3 to 2.6); P = 0.29) while mean motor scores were 102.4 vs 107.3 (MD, –4.9 (95% CI, –11.2 to 1.4); P = 0.13). No differences were seen between the two groups in physical (including genital and neurological examination), behavioral and health‐related outcomes. Conclusion In this sample of children born to low‐risk women with a short cervix at screening, no relevant differences in neurodevelopmental, behavioral, health‐related and physical outcomes were found between offspring exposed to vaginal progesterone and those exposed to placebo. © 2020 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
In women with twin pregnancy and a CL < 38 mm, the use of a cervical pessary strongly improved survival of the children without affecting neurodevelopment at 3 years' corrected age. Copyright © 2018 ISUOG. Published by John Wiley & Sons Ltd.
The aims of this study are (1) to evaluate the performance of current triage for chest pain; (2) to describe the case mix of patients undergoing triage for chest pain; and (3) to identify opportunities to improve performance of current Dutch triage system for chest pain. Chest pain is a common symptom, and identifying patients with chest pain that require urgent care can be quite challenging. Making the correct assessment is even harder during telephone triage. Temporal trends show that the referral threshold has lowered over time, resulting in overcrowding of first responders and emergency services. While various stakeholders advocate for a more efficient triage system, careful evaluation of the performance of the current triage in primary care is lacking. TRiage of Acute Chest pain Evaluation in primary care (TRACE) is a large cohort study designed to describe the current Dutch triage system for chest pain and subsequently evaluate triage performance in regard to clinical outcomes. The study consists of consecutive patients who contacted the out-of-hours primary care facility with chest pain in the region of Alkmaar, the Netherlands, in 2017, with follow-up for clinical outcomes out to August 2019. The primary outcome of interest is ‘major event’, which is defined as the occurrence of death from any cause, acute coronary syndrome, urgent coronary revascularization, or other high-risk diagnoses in which delay is inadmissible and hospitalization is necessary. We will evaluate the performance of the triage system by assessing the ability of the triage system to correctly classify patients regarding urgency (accuracy), the proportion of safe actions following triage (safety) as well as rightfully deployed ambulances (efficacy). TRACE is designed to describe the current Dutch triage system for chest pain in primary care and to subsequently evaluate triage performance in regard to clinical outcomes.
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