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IRIS study


The IUGR RIsk Selection study

 

Go to the website

 

Objective
Of all babies that die after 25 or more weeks gestation, 40% are small]for]gestational age (SGA). In the Netherlands third trimester ultrasound (US) screening is increasingly being used to monitor foetal growth even though evidence on its effectiveness or cost]effectiveness is lacking. The proposed study fulfils the urgent need to evaluate the value of third trimester US for monitoring foetal growth among low risk women in primary care. If shown to be effective, routine third trimester US will contribute to reducing the national perinatal mortality and severe morbidity rate.

 

Study design
A nationwide stepped wedge cluster randomised trial in which primary care midwifery practices will be randomised.

 

Study population
Women who are still in primary care at 26 weeks gestation and who have a singleton pregnancy.

 

Intervention and control strategies
In all midwifery practices, growth will be monitored using standardised symphysis fundal height (SFH) measurement according to the KNOV guideline eDetection of foetal growth restrictionf. In the intervention strategy two routine US examinations will be performed (between 28]30 weeks and 34]36 weeks), while in the control strategy US examination will only be performed when clinically indicated. In both groups the IRIS consensus]based protocol will be followed if intrauterine growth retardation is detected.

 

Outcome measures
The clinical primary outcome is a dichotomous composite measure esevere adverse perinatal outcomef up to 7 days after birth, including: perinatal death; Apgar score below 4 at 5 minutes after birth; impaired consciousness; need for assisted ventilation for more than 24 hours; asphyxia; septicaemia; meningitis; bronchopulmonary dysplasia; intraventricular haemorrhage; cystic periventricular leukomalacia; or necrotizing enterocolitis. Also direct and indirect costs are primary outcomes.

 

Power/data analysis
A total of 15,000 women in 60 midwifery practices; 7,500 women per strategy. Main data analysis will consist of multivariable logistic regression analyses, taking into account the clustered design.

 

Economic evaluation
The economic evaluation will consist of a cost]effectiveness and a cost]utility analysis and will be performed from both a health care provider and societal perspective. We will base all primary analyses on intention to treat.

 

Time schedule
48 months

 

Projectleader
Dr. A. de Jonge, midwife / senior researcher

 

Subsidy
ZonMw

 

Contact
Drs. Viki Verfaille, midwife / junior researcher, +31(0)20 444 17 46,
irisstudie@vumc.nl