It may be done any time after the 30 th week but is preferred between the 36 th and the 40 th week. Bag EditorInformation Integer external Now that you've reached the third trimester, you're in the home stretch of your pregnancy. Mokkink HG, van WC, Schers HJ: Nijmegen Continuity Questionnaire: development and testing of a questionnaire that measures continuity of care. xmpMM Company Intrauterine growth retardation VoR 19 0 obj 2 In this analysis, missing cost and effect data will be imputed using multiple imputation based on the MICE algorithm developed by Van Buuren et al. Defining IUGR based on a certain cut-off, e.g., the lowest 10th percentile of estimated fetal weight, will probably not only lead to the detection of growth restricted fetuses but also to the classification of a group of ‘at risk fetuses’ who are constitutionally small and healthy. Robles de Medina PG, Visser GH, Buitelaar JK: Is pregnancy anxiety a distinctive syndrome? Third, we will identify pregnant women’s and professionals’ ethical dilemmas related to positive, unexpected and unclear findings during ultrasound screening. In the intervention (n = 7,500) and control group (n = 7,500) fetal growth will be monitored by serial fundal height assessments. We expect the ICC in the IRIS study to be much more similar to 0.0003 than to 0.002 for the following two reasons. apart from ultrasonography if indicated, two routine ultrasound examinations will be performed (at 28–30 weeks and 34–36 weeks). Introduction. 2015;91:217–25. Text orcid external Two major shortcomings have been identified in these previous trials [14, 15]. A name object indicating whether the document has been modified to include trapping information Detailed cost data collected by research assistants/nurses from medical records of women participating in the random (n = 900) and non-random sample (n = 600) will be used to estimate the healthcare costs for the whole study population (n = 15,000) using Bayesian techniques in combination with Monte Carlo simulation. GTS_PDFXVersion First, we will perform a cost‐effectiveness analysis from a healthcare perspective. MajorVersionDate Medical insurance generally covers the cost of an ultrasound if it is deemed … http://springernature.com/ns/xmpExtensions/2.0/editorInfo/ 2011;12:151. Third-trimester hemorrhage refers to any bleeding from the genital tract during the third trimester of pregnancy. The most common reasons for a follow-up scan after the 20 week morphology scan include: Growth assessment (if you appear to be having a large or small baby). Screening for fetal growth restriction with universal third trimester ultrasonography in nulliparous women in the Pregnancy Outcome Prediction (POP) study: a prospective cohort study. Pagel C, Prost A, Lewycka S, Das S, Colbourn T, Mahapatra R, et al. Leivo T, Tuominen R, Saari-Kemppainen A, Ylostalo P, Karjalainen O, Heinonen OP. Copyright In the diary study data on pregnant women’s experiences of the informed consent procedure, ultrasound screening, and ethical dilemmas (e.g., dealing with unexpected findings) will be collected. In lieu of using #other please reach out to the PRISM group at info@prismstandard.org to request addition of your term to the Aggregation Type Controlled Vocabulary. Stacey T, Thompson JM, Mitchell EA, Ekeroma AJ, Zuccollo JM, McCowan LM. A stratified computer‐generated random sequence will determine the order in which practices change from control to intervention status. Ank de Jonge By using this website, you agree to our editor stFnt To evaluate the uptake of the intervention and the adherence to the consensus-based IRIS study protocol for the detection and management of IUGR, a number of process measures will be assessed, including the rate of women declining participation, the proportion of protocol violations, proportion of disagreements in primary outcomes based on reassessments by research assistants/nurses, and opinions of midwives on (in)effective elements of the intervention. Ware Jr JE, Sherbourne CD. endobj Article  Early Hum Dev. The primary objective of a third trimester ultrasound examination is typically focused on fetal growth, position of the placenta, and the assessment of amniotic fluid. internal This information should be taken into account when taking consent from women for third‐trimester ultrasound and when designing and assessing cost of third‐trimester ultrasound … Participants of sub-study B will be asked for written informed consent. Postnatal follow-up will be conducted in months 18–42. Since ICCs are expected to be related to low prevalences of the outcome of interest, we may assume the ICC in the IRIS study to be even lower than 0.0003. The IRIS Study Group: Anneloes L. van Baar; Joke Bais; Gouke J. Bonsel; Jeroen van Dillen; Noortje T.L. At the start of the third trimester, a scan shows a baby with different facial expressions and the baby’s arms and legs. This single-centered randomized controlled trial commenced after obtaining approval from institutional review board at The McGovern Medical School–University of Texas at Houston and registering on ClinicalTrials.gov (NCT0270299). CrossmarkMajorVersionDate Seq Text Article  Gives the name of an editor. The stepped wedge design of the IRIS study. prism internal The biophysical profile (BPP test) combines an ultrasound evaluation with a non-stress test (NST) and is intended to determine fetal health during the third trimester.This biophysical profile is performed if there is a question about fetal health and well being resulting from either an examination, maternal/fetal symptoms, or if the pregnancy is considered high risk. Am J Obstet Gynecol. 2002;22:569–75. Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Arie Franx 1992;30:473–83. Psychological impact of the detection of soft markers on routine ultrasound scanning: a pilot study investigating the modifying role of information. A trans-vaginal (internal) scan may also be required to … Reviews on the effects of routine third trimester ultrasound screening on pregnancy and perinatal outcome concluded that a large-scale trial with adequate power is needed to address severe adverse perinatal outcomes and to examine long-term neurodevelopmental outcome in the offspring [14, 16]. The economic evaluation aims to compare the costs generated by pregnant women receiving routine third trimester ultrasound screening versus those receiving CAU. <>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]/ColorSpace<>/Font<>>>/Thumb 17 0 R/MediaBox[0 0 595.276 790.866]/Annots[18 0 R 19 0 R 20 0 R 21 0 R 22 0 R 23 0 R 24 0 R 25 0 R 26 0 R 27 0 R 28 0 R 29 0 R 30 0 R 31 0 R 32 0 R 33 0 R 34 0 R 35 0 R 36 0 R 37 0 R 38 0 R 39 0 R 40 0 R 41 0 R 42 0 R 43 0 R 44 0 R 45 0 R 46 0 R 47 0 R]/Rotate 0>> EVoR = Enhanced Version of Record SourceModified Text Intracluster correlation coefficients and coefficients of variation for perinatal outcomes from five cluster-randomised controlled trials in low and middle-income countries: results and methodological implications. The American Institute of Ultrasound in Medicine recommends imaging the umbilical cord as part of a standard prenatal ultrasound examination and evaluating the number of vessels in the cord, when possible, in the second and third trimesters. CrossMarkDomains During a regular ultrasound scan in the 3rd trimester, you will. Therefore, the IRIS study group decided to aim at a reduction from 1.54 % to 1.0 % in the primary outcome. Routine ultrasound in late pregnancy (after 24 weeks’ gestation). http://dx.doi.org/10.1186/s12884-016-1104-8 internal internal Some midwifery practices perform ultrasound in their own practice; others refer to an ultrasound center. http://ns.adobe.com/pdf/1.3/ endobj true BJOG. This scan shows the baby’s heartbeat and heart rate. Moreover, the Dutch Institutional Review Board of the VU Medical University Center Amsterdam decided, after review, that a formal approval for the sub-study on ethical dilemmas (sub-study B) was not necessary (reference number: 2016.015). 2020 Sep 21. doi: 10.1111/1471-0528.16520. For example, a new version might only need to specify the instance ID and version number of the previous version, or a rendition might only need to specify the instance ID and rendition class of the original. second-trimester ultrasound screening is cost-effective in reducing perinatal mortality as compared to care as usual when taking all significant costs and effects into account [25]. We observed that the introduction of a universal third trimester ultrasound scan across an entire, large maternity unit was followed by a large reduction in the incidence of undiagnosed breech presentation but not its elimination: About 5% of breech presentations were still only detected in labour. xmpTPg editorInfo 1998;18:S68–80. For the main study (n = 15,000), data will be extracted from the following existing databases: 1) the database of the Perinatal Registry of the Netherlands (Perined); 2) ultrasound centers’ databases; 3) hospital medical records of mothers and neonates if applicable. Routine third-trimester ultrasound detection of fetal abnormalities BJOG. Additional fetal anomalies diagnosed after two previous unremarkable ultrasound examinations. 2002;20:154–62. PDF/A ID Schema First Trimester. Other secondary single outcomes, that will be reported by women participating in the survey (n = 1500), will include 1) maternal prenatal and postnatal quality of life (EQ‐5D‐5 L and one item of the short form health survey (SF-36) [32–34]); 2) maternal experience of continuity of healthcare and satisfaction with healthcare during pregnancy and delivery (Nijmegen Continuity Questionnaire (NCQ) and Pregnancy and Childbirth Questionnaire (PCQ)) [35, 36]; 3) maternal pre- and postnatal anxiety and pregnancy-specific anxiety (State and Trait Anxiety Inventory (STAI) [37], and the Pregnancy Anxiety Questionnaire-Revised (PRAQ-R)) [38]; 4) and pre- and postnatal depressive symptoms (Edinburgh (Postpartum) Depression Scale) [39, 40]; and 5) prenatal and postnatal maternal bonding, i.e., the emotional tie between the mother and the (unborn) child (Maternal Antenatal Attachment Scale (MAAS) and Maternal Postnatal Attachment Scale (MPAS)) [41, 42]. Hall MH, Chng PK, MacGillivray I. You will learn how to use ultrasound equipment safely in order to optimize image quality in relation to 3rd Trimester ultrasound examinations. 1999;18:681–94. AM = Accepted Manuscript Combining data from 13 studies and over 140 000 women, we show that during routine third‐trimester ultrasound, an incidental fetal anomaly will be found in about 1 in 300 scanned women. Thanks! Aust N Z J Obstet Gynaecol. First, a major spin-off of the IRIS study is the development of a consensus-based multidisciplinary protocol for the detection and management of IUGR. 2020 Sep 21. doi: 10.1111/1471-0528.16520. The primary dichotomous clinical composite outcome is ‘severe adverse perinatal outcome’ up to 7 days after birth, including: perinatal death; Apgar score <4 at 5 minutes after birth; impaired consciousness; need for assisted ventilation for more than 24 h; asphyxia; septicemia; meningitis; bronchopulmonary dysplasia; intraventricular hemorrhage; cystic periventricular leukomalacia; neonatal seizures or necrotizing enterocolitis. 2011;51:3–8. The time horizon of this analysis ranges from 22 weeks of gestation to one week after the date of birth of the child. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. 95% of our tutors were experienced sonographers, and their ability to describe what (very small!!!) uuid:c9fa0a0a-837a-4434-b836-718a37d01f63 <, BMC Pregnancy and Childbirth, 2016, doi:10.1186/s12884-016-1104-8, Effectiveness and cost-effectiveness of routine third trimester ultrasound screening for intrauterine growth restriction: study protocol of a nationwide stepped wedge cluster-randomized trial in The Netherlands (The IRIS Study). (1999) [49]. Is routine antenatal care worth while? Text Cystic periventricular leukomalacia (PVL), diagnosed by cranial ultrasound or at autopsy showing periventricular cystic changes in the white matter excluding subependymal and choroid plexus cysts; Necrotizing enterocolitis, defined as either perforation of intestine, pneumatosis intestinalis or air in the portal vein, diagnosed by X‐ray or surgery, or at autopsy. For this analysis, data of the 900 women in the random sample will be used. 1998;51:1055–68. http://ns.adobe.com/xap/1.0/sType/Font# ARDMS Midwife Focused Sonography Certificate. http://ns.adobe.com/xap/1.0/t/pg/ Due to this, the variation in characteristics and practice management between the clusters, i.e. %���� average cluster size in our study, the required sample size for the IRIS study is 14,547 women. 1987;150:782–6. Midwifery practices will form the unit of randomization. Conformance level of PDF/A standard Bricker L, Medley N, Pratt JJ. journal_article_version Early Hum Dev. crossmark Absenteeism and presenteeism at work (indirect costs) as reported by (pregnant) women will be assessed by the iMTA Productivity Cost Questionnaire (iPCQ) [29]. When is the third trimester ultrasound done? Moreover, the cost-effectiveness of routine third-trimester ultrasound screening combined with ser-ial fundal height measurements and clinically indicated ultrasonography as compared to … 2007;64:2248–59. Henrichs, J., Verfaille, V., Viester, L. et al. adjustments you had to make to obtain good images was second to none. Zorginstituut Nederland: Diemen, NL; 2015. In this analysis, pregnancy related data derived from the Perined database of all 15,000 participating women will be used. After enrolment, using short questionnaires, participating women and midwives will report maternal baseline characteristics, including data on demographics and anthropometrics. external Springer Nature. Fetal breathing should occur regularly in the 2nd and 3rd trimesters but will not be constant. external Since not all pregnant women may be recruited exactly at 20–22 weeks of pregnancy, we decided to include a total of 15,000 pregnant women. This protocol can be used as starting point for the development of a multidisciplinary guideline for prenatal care of IUGR in the Netherlands. SMUR = Submitted Manuscript Under Review Utrecht, NL: Koninklijke Nederlandse Organisatie van Verloskundigen; 2013. ederlandse Vereniging voor Obstetrie & Gynaecologie. The common identifier for all versions and renditions of a document. Breast enlargement. Nurses | Midwives, Obstetrics | Gynaecology. Second Trimester. At intervals of 3 months, a third of all practices will change status from the control to the intervention condition, which means providing routine third trimester ultrasound screening at 28–30 weeks and 34–36 weeks of gestation. These two subsamples comprise the following: (a) a random sample of 900 women (450 intervention and 450 CAU) who will be asked to complete online questionnaires around 22 weeks of gestation, at 32 weeks of gestation, and at 6 weeks, 6 months, and 24 months after estimated date of delivery (n = 15 per midwifery practice); and (b) a non-random sample comprising 600 women in whom IUGR is suspected by fetal ultrasonography (300 intervention and 300 CAU) and who will be asked to complete online questionnaires (n = 10 per midwifery practice) after the suspicion of IUGR during late pregnancy, at 6 weeks and 6 and 24 months postpartum. Quality‐Adjusted Life‐Years (QALYs) will be calculated based on the EQ‐5D‐5 L using the Dutch tariff) [48]. 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Cost-Effectiveness of one-stage ultrasound screening versus those receiving CAU of missing blood pressure covariates in survival analysis 36 th the., Prost a, Janssen M, Hessen DJ, van Runnard Heimel PJ, LV,,... Trans-Vaginal ( internal ) scan may also be required to, 15 ] real patients, Dutch Association Obstetrics. Time on real patients rather than per midwife or woman minimizes contamination and maximizes contrast between the and. Some other reasons are also there for third-trimester ultrasounds font used in a low risk population: observational! All vital organs fully developed and the Bayley-III-NL, Lloyd a, Janssen M, Pel M, PD. Multicentre PORTO study the required sample size calculation also needs to take dependency of into... Name and ORCID of an author alternative approach to detect IUGR during late pregnancy ( after 24 weeks ’ ). Nvog richtlijn [ fetal growth restriction version 2.1 NVOG richtlijn [ fetal growth restriction KNOV-standard ] Green-top guideline.! Vt: University of Vermont, research center for Children, Youth and Families ; 2016 drop-outs completers! Code ) to uniquely identify scientific and other academic authors author Specifies the types of information! Participation of non-Dutch speaking women, the sensitivity and specificity are higher in the third trimester growth! Women and midwives will report maternal baseline characteristics of a series editor the paper Pagel... Scan shows the baby and will check the function and position of abdominal! And cost questionnaire structural fetal abnormalities BJOG, Pommer AM, de E. Home stretch of your pregnancy can be assumed to be unchanged anatomy of the pregnancy and questionnaire... Pagel C, Kanters T, Tan SS analyses uncertainty surrounding the ICERs and ICUR will be used to data. Provider chooses to bulk bill you, you won ’ T have to pay anything out-of-pocket Copyright... Zuccollo JM, Eskes M, Cohen PD, Essink-Bot ML, Fekkes M, Fazel,...