Cost-Effectiveness of Routine Third Trimester Ultrasound Screening for Fetal Growth Restriction Compared to Care as Usual in Low-Risk Pregnancies: A Pragmatic Nationwide Stepped-Wedge Cluster-Randomized Trial in The Netherlands (the IRIS Study)

Abstract

Routine third trimester ultrasonography is increasingly used to screen for fetal growth restriction. However, evidence regarding its cost-effectiveness is lacking. We aimed to evaluate the cost-effectiveness of routine third trimester ultrasonography to reduce adverse perinatal outcomes compared to usual care (selective ultrasonography). An economic evaluation alongside a stepped-wedge cluster-randomized trial was conducted. Via 60 midwifery practices 12,974 Dutch women aged ≥16 years with low-risk pregnancies were enrolled at 22.8 (SD = 2.4) weeks' gestation. All practices provided usual care. At 3, 7, and 10 months a third of the practices were randomized to the intervention strategy providing routine ultrasonography at 28-30 and 34-36 weeks' gestation and usual care. The primary clinical outcome was a dichotomous composite measure of 12 severe adverse perinatal outcomes (SAPO) up to one week postpartum. Information on perinatal care and societal costs was derived from Netherlands Perinatal Registry, hospital records and a survey. Cost-effectiveness analyses revealed no significant differences in SAPO and healthcare and societal costs between the intervention strategy (n = 7026) and usual care (n = 5948). Cost-effectiveness acceptability curves showed that the probability of cost-effectiveness was never higher than 0.6 for all possible ceiling ratios. Adding routine third trimester ultrasonography to usual care is not cost-effective in reducing SAPO.

Keywords: cluster-randomized trial; economic evaluation; routine third trimester ultrasonography; severe adverse perinatal outcome.

Figure 1

Decision tree showing possible outcome pathways.

Figure 2

(a) Cost-effectiveness plane for analysis 1 (time horizon one week after birth, adverse outcomes averted, Perined data only). The Northeast (NE) quadrant indicates that routine ultrasonography is more effective and more costly than usual care. The Southeast (SE) quadrant indicates that routine ultrasonography is more effective and less costly than usual care. The Southwest (SW) quadrant indicates that routine ultrasonography is less effective and less costly than usual care. The Northwest (NW) quadrant indicates that routine ultrasonography is less effective and more costly than usual care. (b) Cost-effectiveness acceptability curve for analysis 1 (time horizon one week after birth, adverse outcomes averted, Perined data only). The y axis shows the probability that routine ultrasonography is cost-effective compared to usual care. The x axis shows the maximum amount of money that society is willing to pay to avert one adverse outcome.

Figure 3

(a) Cost-effectiveness plane for analysis 2 (time horizon six months after birth, adverse outcomes averted). The Northeast (NE) quadrant indicates that routine ultrasonography is more effective and more costly than usual care. The Southeast (SE) quadrant indicates that routine ultrasonography is more effective and less costly than usual care. The Southwest (SW) quadrant indicates that routine ultrasonography is less effective and less costly than usual care. The Northwest (NW) quadrant indicates that routine ultrasonography is less effective and more costly than usual care. (b) Cost-effectiveness acceptability curve for analysis 2 (time horizon six months after birth, adverse outcomes averted). The y axis shows the probability that routine ultrasonography is cost-effective compared to usual care. The x axis shows the maximum amount of money that society is willing to pay to avert one adverse outcome.

Figure 3

(a) Cost-effectiveness plane for analysis 2 (time horizon six months after birth, adverse outcomes averted). The Northeast (NE) quadrant indicates that routine ultrasonography is more effective and more costly than usual care. The Southeast (SE) quadrant indicates that routine ultrasonography is more effective and less costly than usual care. The Southwest (SW) quadrant indicates that routine ultrasonography is less effective and less costly than usual care. The Northwest (NW) quadrant indicates that routine ultrasonography is less effective and more costly than usual care. (b) Cost-effectiveness acceptability curve for analysis 2 (time horizon six months after birth, adverse outcomes averted). The y axis shows the probability that routine ultrasonography is cost-effective compared to usual care. The x axis shows the maximum amount of money that society is willing to pay to avert one adverse outcome.