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Effectiveness of routine third trimester ultrasonography to reduce adverse perinatal outcomes in low risk pregnancy (the IRIS study): nationwide, pragmatic, multicentre, stepped wedge cluster randomised trial

Henrichs, J; Verfaille, V; Jellema, P; Viester, L; Pajkrt, E; Wilschut, J; van der Horst, HE; Franx, A; de Jonge, A; van Baar, AL; et al. Henrichs, J; Verfaille, V; Jellema, P; Viester, L; Pajkrt, E; Wilschut, J; van der Horst, HE; Franx, A; de Jonge, A; van Baar, AL; Bais, JMJ; Bonsel, GJ; Bosmans, JE; van Dillen, J; van Duijnhoven, NTL; Grobman, WA; Groen, H; Hukkelhoven, CWPM; Klomp, T; Kok, M; de Kroon, ML; Kruijt, M; Kwee, A; Ledda, S; Lafeber, HN; van Lith, JMM; Mol, BW; Molewijk, B; Nieuwenhuijze, M; Oei, G; Oudejans, C; Paarlberg, KM; Papageorghiou, AT; Reddy, UM; De Reu, P; Rijnders, M; de Roon-Immerzeel, A; Scheele, C; Scherjon, SA; Snijders, R; Spaanderman, ME; Teunissen, PW; Torij, HW; Vrijkotte, TG; Westerneng, M; Zeeman, KC; Zhang, JJ; Grp, IRISS (2019) Effectiveness of routine third trimester ultrasonography to reduce adverse perinatal outcomes in low risk pregnancy (the IRIS study): nationwide, pragmatic, multicentre, stepped wedge cluster randomised trial. BMJ-BRITISH MEDICAL JOURNAL, 367. l5517. ISSN 1756-1833 https://doi.org/10.1136/bmj.l5517
SGUL Authors: Papageorghiou, Aris

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Abstract

Objectives To 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. Design Pragmatic, multicentre, stepped wedge cluster randomised trial. Setting 60 midwifery practices in the Netherlands. Participants 13 046 women aged 16 years or older with a low risk singleton pregnancy. Interventions 60 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 measures The primary outcome measure was a composite of severe adverse perinatal outcomes: perinatal death, Apgar score <4, impaired consciousness, asphyxia, seizures, assisted ventilation, septicaemia, meningitis, bronchopulmonary dysplasia, intraventricular haemorrhage, periventricular leucomalacia, or necrotising enterocolitis. Secondary outcomes were two composite measures of severe maternal morbidity, and spontaneous labour and birth. Results Between 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%), P<0.001). The incidence of severe adverse perinatal outcomes was 1.7% (n=118) for the intervention strategy and 1.8% (n=106) for usual care. After adjustment for confounders, the difference between the groups was not significant (odds ratio 0.88, 95% confidence interval 0.70 to 1.20). The intervention strategy showed a higher incidence of induction of labour (1.16, 1.04 to 1.30) and a lower incidence of augmentation of labour (0.78, 0.71 to 0.85). Maternal outcomes and other obstetric interventions did not differ between the strategies. Conclusion In 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 registration Netherlands Trial Register NTR4367.

Item Type: Article
Additional Information: This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
SGUL Research Institute / Research Centre: Academic Structure > Institute of Medical & Biomedical Education (IMBE)
Academic Structure > Institute of Medical & Biomedical Education (IMBE) > Centre for Clinical Education (INMECE )
Journal or Publication Title: BMJ-BRITISH MEDICAL JOURNAL
ISSN: 1756-1833
Dates:
DateEvent
15 October 2019Published
27 August 2019Accepted
Publisher License: Creative Commons: Attribution-Noncommercial 4.0
Projects:
Project IDFunderFunder ID
209030001Netherlands Organisation for Health Research and Developmenthttp://dx.doi.org/10.13039/501100001826
Web of Science ID: WOS:000492058400001
URI: http://sgultest.da.ulcc.ac.uk/id/eprint/111356
Publisher's version: https://doi.org/10.1136/bmj.l5517

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