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
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 language | English |
|---|---|
| Article number | 5517 |
| Pages (from-to) | 1-13 |
| Number of pages | 13 |
| Journal | BMJ (e) |
| Volume | 367 |
| DOIs | |
| Publication status | Published - 15 Oct 2019 |
Keywords
- FETAL-GROWTH RESTRICTION
- BIRTH-WEIGHT
- NULLIPAROUS WOMEN
- MANAGEMENT
- ULTRASOUND
- PREDICTION
- STILLBIRTH
- CONSENSUS
- INFANTS
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- 10.1136/bmj.l5517Licence: CC BY-NC
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In: BMJ (e), Vol. 367, 5517, 15.10.2019, p. 1-13.
Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - Effectiveness of routine third trimester ultrasonography to reduce adverse perinatal outcomes in low risk pregnancy (the IRIS study)
T2 - nationwide, pragmatic, multicentre, stepped wedge cluster randomised trial
AU - Henrichs, Jens
AU - Verfaille, Viki
AU - Jellema, Petra
AU - Viester, Laura
AU - Pajkrt, Eva
AU - Wilschut, Janneke
AU - van der Horst, Henriette E.
AU - Franx, Arie
AU - de Jonge, Ank
AU - van Baar, Anneloes L.
AU - Bais, Joke M. J.
AU - Bonsel, Gouke J.
AU - Bosmans, Judith E.
AU - van Dillen, Jeroen
AU - van Duijnhoven, Noortje T. L.
AU - Grobman, William A.
AU - Groen, Henk
AU - Hukkelhoven, Chantal W. P. M.
AU - Klomp, Trudy
AU - Kok, Marjolein
AU - de Kroon, Marlou L.
AU - Kruijt, Maya
AU - Kwee, Anneke
AU - Ledda, Sabina
AU - Lafeber, Harry N.
AU - van Lith, Jan M. M.
AU - Mol, Ben Willem
AU - Molewijk, Bert
AU - Nieuwenhuijze, Marianne
AU - Oei, Guid
AU - Oudejans, Cees
AU - Paarlberg, K. Marieke
AU - Papageorghiou, Aris T.
AU - Reddy, Uma M.
AU - De Reu, Paul
AU - Rijnders, Marlies
AU - de Roon-Immerzeel, Alieke
AU - Scheele, Connie
AU - Scherjon, Sicco A.
AU - Snijders, Rosalinde
AU - Spaanderman, Marc E.
AU - Teunissen, Pim W.
AU - Torij, Hanneke W.
AU - Vrijkotte, Tanja G.
AU - Westerneng, Myrte
AU - Zeeman, Kristel C.
AU - Zhang, Jun Jim
AU - IUGR Risk Selection (IRIS) study group
N1 - Funding Information: Funding: This study was supported by a grant from the Netherlands Organisation for Health Research and Development (ZonMw; grant No 209030001). This funding source had no role in study design, data collection, data analysis, data interpretation, writing of the scientific article, or the decision to submit the paper for publication. Funding Information: The IRIS study group: Anneloes L van Baar, Utrecht University, Utrecht, Netherlands; Joke M J Bais, Medical Centre Alkmaar, Alkmaar, Netherlands; Gouke J Bonsel, University Medical Centre Utrecht, Utrecht, Netherlands; Judith E Bosmans, VU University Amsterdam, Amsterdam, Netherlands; Jeroen van Dillen, Radboud University Medical Centre, Nijmegen, Netherlands; Noortje T L van Duijnhoven, Radboud University Medical Centre, Nijmegen, Netherlands; William A Grobman, Northwestern University, Chicago, IL, USA; Henk Groen, University of Groningen, Groningen, Netherlands; Chantal W P M Hukkelhoven, Wageningen University and Research, Wageningen, Netherlands; Trudy Klomp, Amsterdam University Medical Centre/ AVAG, Amsterdam, Netherlands; Marjolein Kok, Amsterdam University Medical Centre, Amsterdam, Netherlands; Marlou L de Kroon, University of Groningen, Groningen, Netherlands; Maya Kruijt, Dutch Society of Obstetrics and Gynaecology NVOG, Utrecht, Netherlands; Anneke Kwee, University Medical Centre Utrecht, Utrecht, Netherlands; Sabina Ledda, Midwifery practice het Palet/ BEN, Rotterdam, Netherlands; Harry N Lafeber, Amsterdam University Medical Centre, Netherlands; Jan M M van Lith, Leiden University Medical Centre, Leiden, Netherlands; Ben Willem Mol, University of Adelaide, Adelaide, Australia; Bert Molewijk, Amsterdam University Medical Centre, Amsterdam, Netherlands; Marianne Nieuwenhuijze, Academie Verloskunde Maastricht, Maastricht, Netherlands; Guid Oei, Maxima Medical Centre, Eindhoven, Netherlands; Cees Oudejans, Amsterdam University Medical Centre, Amsterdam, Netherlands; K Marieke Paarlberg, Gelre Hospitals, location Apeldoorn, Netherlands; Aris T Papageorghiou, University of Oxford, Oxford, UK; Uma M Reddy, Yale University, New Haven, CT, USA; Paul De Reu, Prenataal Screenigscentrum “de Meierij,” Eindhoven, Netherlands; Marlies Rijnders, TNO, Leiden, Netherlands; Alieke de Roon-Immerzeel, Royal Dutch Organisation of Midwives, Netherlands; Connie Scheele, University Medical Centre Utrecht/BEN, Utrecht, Netherlands; Sicco A Scherjon, University Medical Centre Groningen, Groningen, Netherlands; Rosalinde Snijders, Amsterdam University Medical Centre, Amsterdam, Netherlands; Marc E Spaanderman, University Medical Centre Maastricht, Maastricht, Netherlands; Pim W Teunissen, Amsterdam University Medical Centre, Amsterdam, Netherlands; Hanneke W Torij, Rotterdam University of Applied Sciences, Rotterdam, Netherlands; Tanja G Vrijkotte, Amsterdam University Medical Centre, Amsterdam, Netherlands; Myrte Westerneng, Amsterdam University Medical Centre, Amsterdam, Netherlands Kristel C Zeeman, University of Amsterdam, Amsterdam, Netherlands; and Jun Jim Zhang, Shanghai Jiao Tong University School of Medicine, Shanghai, China. Contributors: JH and VV contributed equally to the manuscript and are first authors. AdJ, AF, HEvdH, PJ, VV, and EP conceived and designed the study. AdJ, PJ, LV, VV, and JH were involved in the development, implementation, or data collection of the study. JH, JW, and VV conducted data analyses. JH, VV, and AdJ drafted the manuscript and interpreted the results. All authors critically revised the manuscript for important intellectual content, approved its final version, and agree to be accountable for all aspects of the work presented in this manuscript. AdJ is the guarantor. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. Publisher Copyright: © Published by the BMJ Publishing Group Limited.
PY - 2019/10/15
Y1 - 2019/10/15
N2 - 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 scoreRESULTSBetween 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
AB - 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 scoreRESULTSBetween 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
KW - FETAL-GROWTH RESTRICTION
KW - BIRTH-WEIGHT
KW - NULLIPAROUS WOMEN
KW - MANAGEMENT
KW - ULTRASOUND
KW - PREDICTION
KW - STILLBIRTH
KW - CONSENSUS
KW - INFANTS
U2 - 10.1136/bmj.l5517
DO - 10.1136/bmj.l5517
M3 - Article
SN - 1756-1833
VL - 367
SP - 1
EP - 13
JO - BMJ (e)
JF - BMJ (e)
M1 - 5517
ER -