Cost-effectiveness of single-layer versus double-layer uterine closure during caesarean section on postmenstrual spotting: economic evaluation alongside a randomised controlled trial

Abstract

Objective: To evaluate the cost-effectiveness of double-layer compared with single-layer uterine closure after a first caesarean section (CS) from a societal and healthcare perspective.

Design: Economic evaluation alongside a multicentre, double-blind, randomised controlled trial.

Setting: 32 hospitals in the Netherlands, 2016-2018.

Participants: 2292 women ≥18 years undergoing a first CS were randomly assigned (1:1). Exclusion criteria were: inability for counselling, previous uterine surgery, known menstrual disorder, placenta increta or percreta, pregnant with three or more fetuses. 1144 women were assigned to single-layer and 1148 to double-layer closure. We included 1620 women with a menstrual cycle in the main analysis.

Interventions: Single-layer unlocked uterine closure and double-layer unlocked uterine closure with the second layer imbricating the first.

Main outcome measures: Spotting days, quality-adjusted life-years (QALYs), and societal costs at 9 months of follow-up. Missing data were imputed using multiple imputation.

Results: No significant differences were found between single-layer versus double-layer closure in mean spotting days (1.44 and 1.39 days; mean difference (md) -0.056, 95% CI -0.374 to 0.263), QALYs (0.663 and 0.658; md -0.005, 95% CI -0.015 to 0.005), total healthcare costs (€744 and €727; md €-17, 95% CI -273 to 143), and total societal costs (€5689 and €5927; md €238, 95% CI -624 to 1108). The probability of the intervention being cost-effective at willingness-to-pay of €0, €10 000 and €20 000/QALY gained was 0.30, 0.27 and 0.25, respectively, (societal perspective), and 0.55, 0.41 and 0.32, respectively, (healthcare perspective).

Conclusion: Double-layer uterine closure is not cost-effective compared with single-layer uterine closure from both perspectives. If this is confirmed by our long-term reproductive follow-up, we suggest to adjust uterine closure technique guidelines.

Trial registration number: NTR5480/NL5380.

Keywords: health economics; maternal medicine; obstetrics; ultrasonography.

Figure 1

Trial profile. *Logistical reasons, computer randomisation issues, passing through the allocated method to operating gynaecologist, or participant not traceable after randomisation. QALYs, quality-adjusted life-years.

Figure 2

Cost-effectiveness planes and cost acceptability curves from a societal and healthcare perspective comparing double-layer to single-layer uterine closure. (1) Cost-effectiveness plane (CE plane) showing the incremental cost-effectiveness ratio point estimate (ICER, red dot) and the distribution of the 5000 replications of the bootstrapped cost-effective pairs (blue dots). (2) Cost-effectiveness acceptability curve (CEAC) indicating the probability of double-layer uterine closure being cost-effective compared with single-layer closure (y-axis) for different willingness-to-pay (WTP) thresholds per unit of effect gained (x-axis). (A) CE plane for spotting days from a societal perspective showing that most of bootstrapped cost-effect pairs were equally distributed across CE plane quadrants representing high uncertainty around ICER. (B) CEAC for spotting days from a societal perspective indicating a steady 0.2 probability of double-layer uterine closure being cost-effective compared with single-layer closure for different WTP thresholds per fewer spotting days. (C) CE plane for QALYs from a societal perspective showing that most of the bootstrapped cost-effect pairs were in the Northern quadrants (ie, higher costs) and Western quadrants where double-layer uterine closure was less effective compared with single-layer closure. (D) CEAC for QALYs from a societal perspective indicating a probability of double-layer uterine closure being cost-effective around 0.2 for different WTP thresholds per QALY gained. (E) CE plane for spotting days from a healthcare perspective showing that most of the bootstrapped cost-effect pairs were in Southern quadrants, where double-layer uterine closure was less costly compared with single-layer closure, but they are equally distributed across the Eastern and Western quadrants representing high uncertainty around the effectiveness of double-layer uterine closure compared with single-layer closure. (F) CEAC for spotting days from a healthcare perspective indicating a steady 0.6 probability of double-layer uterine closure being cost-effective compared with single-layer closure for different WTP thresholds per fewer spotting days. (G) CE-plane for QALYs from a healthcare perspective showing that most of the bootstrapped cost-effect pairs were in the Southern quadrants (ie, lower costs) and Western quadrants where double-layer uterine closure was less effective compared with single-layer closure. (H) CEAC for QALYs from a healthcare perspective indicating that the probability of double-layer uterine closure being cost-effective compared with single-layer closure decreased with an increasing of the different WTP thresholds per QALY gained because healthcare costs were on average lower in the intervention group while it is less effective compared with the usual practice.