Publication

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

IRIS Study Grp, Henrichs, J., Verfaille, V., Jellema, P., Viester, L., Pajkrt, E., Wilschut, J., van der Horst, H. E., Franx, A. & de Jonge, A., 15-Oct-2019, In : BMJ-British Medical Journal. 367, 13 p., 5517.

Research output: Contribution to journalArticleAcademicpeer-review

  • IRIS Study Grp
  • Jens Henrichs
  • Viki Verfaille
  • Petra Jellema
  • Laura Viester
  • Eva Pajkrt
  • Janneke Wilschut
  • Henriette E. van der Horst
  • Arie Franx
  • Ank de Jonge

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

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

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

Original languageEnglish
Article number5517
Number of pages13
JournalBMJ-British Medical Journal
Volume367
Publication statusPublished - 15-Oct-2019

    Keywords

  • FETAL-GROWTH RESTRICTION, BIRTH-WEIGHT, NULLIPAROUS WOMEN, MANAGEMENT, ULTRASOUND, PREDICTION, STILLBIRTH, CONSENSUS, INFANTS

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