1. Effectiveness of routine third trimester ultrasonography to reduce adverse perinatal outcomes in low risk pregnancy (the IRIS study)
- Author
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Henrichs, J., Verfaille, V., Jellema, P., Viester, L., Pajkrt, E., Wilschut, J., Horst, H.E. van der, Franx, A., Jonge, A. de, Baar, A.L. van, Bais, J.M.J., Bonsel, G.J., Bosmans, J.E., Dillen, J. van, Duijnhoven, N.T.L. van, Grobman, W.A., Groen, H., Hukkelhoven, C.W.P.M., Klomp, T., Kok, M., Kroon, M.L. de, Kruijt, M., Kwee, A., Ledda, S., Lafeber, H.N., Lith, J.M.M. van, Mol, B., Molewijk, B., Nieuwenhuijze, M., Oei, G., Oudejans, C., Paarlberg, K.M., Papageorghiou, A.T., Reddy, U.M., Reu, P. de, Rijnders, M., Roon-Immerzeel, A. de, Scheele, C., Scherjon, S.A., Snijders, R., Spaanderman, M.E., Teunissen, P.W., Torij, H.W., Vrijkotte, T.G., Westerneng, M., Zeeman, K.C., Zhang, J.J., IRIS Study Grp, Obstetrie & Gynaecologie, MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), RS: GROW - R4 - Reproductive and Perinatal Medicine, Obstetrics & Gynecology, Value, Affordability and Sustainability (VALUE), Reproductive Origins of Adult Health and Disease (ROAHD), Methods in Medicines evaluation & Outcomes research (M2O), Public Health Research (PHR), Obstetrics and Gynaecology, APH - Personalized Medicine, APH - Quality of Care, ARD - Amsterdam Reproduction and Development, Amsterdam Reproduction & Development (AR&D), Midwifery Science, Public and occupational health, Obstetrics and gynaecology, APH - Mental Health, General practice, and APH - Aging & Later Life
- Subjects
PREDICTION ,Psychological intervention ,INFANTS ,Infant, Newborn, Diseases ,law.invention ,0302 clinical medicine ,Randomized controlled trial ,Pregnancy ,law ,Cluster Analysis ,030212 general & internal medicine ,Cluster randomised controlled trial ,ULTRASOUND ,Netherlands ,Fetal Growth Retardation ,030219 obstetrics & reproductive medicine ,STILLBIRTH ,Obstetrics ,Incidence ,Pregnancy Outcome ,General Medicine ,medicine.anatomical_structure ,Infant, Small for Gestational Age ,Pregnancy in Adolescence ,Gestation ,Female ,Apgar score ,Ultrasonography ,medicine.medical_specialty ,Adolescent ,Pregnancy Trimester, Third ,Birth weight ,Midwifery ,Third trimester ,Ultrasonography, Prenatal ,Healthcare improvement science Radboud Institute for Health Sciences [Radboudumc 18] ,03 medical and health sciences ,Low risk pregnancy ,All institutes and research themes of the Radboud University Medical Center ,medicine ,MANAGEMENT ,Humans ,Stepped wedge ,Fundal height ,Iris (anatomy) ,Perinatal Mortality ,business.industry ,Research ,Other Research Radboud Institute for Health Sciences [Radboudumc 0] ,Infant, Newborn ,NULLIPAROUS WOMEN ,medicine.disease ,BIRTH-WEIGHT ,Apgar Score ,Small for gestational age ,business ,FETAL-GROWTH RESTRICTION ,CONSENSUS - Abstract
ObjectivesTo investigate the effectiveness of routine ultrasonography in the third trimester in reducing adverse perinatal outcomes in low risk pregnancies compared with usual care and the effect of this policy on maternal outcomes and obstetric interventions.DesignPragmatic, multicentre, stepped wedge cluster randomised trial.Setting60 midwifery practices in the Netherlands.Participants13 046 women aged 16 years or older with a low risk singleton pregnancy.Interventions60 midwifery practices offered usual care (serial fundal height measurements with clinically indicated ultrasonography). After 3, 7, and 10 months, a third of the practices were randomised to the intervention strategy. As well as receiving usual care, women in the intervention strategy were offered two routine biometry scans at 28-30 and 34-36 weeks’ gestation. The same multidisciplinary protocol for detecting and managing fetal growth restriction was used in both strategies.Main outcome measuresThe primary outcome measure was a composite of severe adverse perinatal outcomes: perinatal death, Apgar score ResultsBetween 1 February 2015 and 29 February 2016, 60 midwifery practices enrolled 13 520 women in mid-pregnancy (mean 22.8 (SD 2.4) weeks’ gestation). 13 046 women (intervention n=7067, usual care n=5979) with data based on the national Dutch perinatal registry or hospital records were included in the analyses. Small for gestational age at birth was significantly more often detected in the intervention group than in the usual care group (179 of 556 (32%) v 78 of 407 (19%), PConclusionIn low risk pregnancies, routine ultrasonography in the third trimester along with clinically indicated ultrasonography was associated with higher antenatal detection of small for gestational age fetuses but not with a reduced incidence of severe adverse perinatal outcomes compared with usual care alone. The findings do not support routine ultrasonography in the third trimester for low risk pregnancies.Trial registrationNetherlands Trial Register NTR4367.
- Published
- 2019