biostudies-literatureStegwee SIZonMwe044340https://www.ebi.ac.uk/biostudies/studies/S-EPMC8256741biostudies-literatureUnknown11(7)<h4>Objective</h4>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.<h4>Design</h4>Economic evaluation alongside a multicentre, double-blind, randomised controlled trial.<h4>Setting</h4>32 hospitals in the Netherlands, 2016-2018.<h4>Participants</h4>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.<h4>Interventions</h4>Single-layer unlocked uterine closure and double-layer unlocked uterine closure with the second layer imbricating the first.<h4>Main outcome measures</h4>Spotting days, quality-adjusted life-years (QALYs), and societal costs at 9 months of follow-up. Missing data were imputed using multiple imputation.<h4>Results</h4>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).<h4>Conclusion</h4>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.<h4>Trial registration number</h4>NTR5480/NL5380.BMJ openCost-effectiveness of single-layer versus double-layer uterine closure during caesarean section on postmenstrual spotting: economic evaluation alongside a randomised controlled trial.PMC8256741843002605Voet LFVBekker MNAlili MEEl Alili MFeitsma AHGroot CJde Groot CJMMeijer WJHuisjes AJde Vleeschouwer LLangenveld Jvan Baal WMRadder CM2Close study groupHink EVisser HBeek EVBen AJHermes WScheepers HRijnders RJvan der Voet LFHemelaar MLaar JOVSueters MVliet HAVJanssen CPajkrt ESchippers DHEijndhoven HWVBosmans JEBoer KBoormans EMPapatsonis DNHuirne JAOei ALKesteren PJVHuirne JAFStegwee SIHehenkamp WJSchuitemaker NWKapiteijn KKaplan MfalseCost-effectiveness of single-layer versus double-layer uterine closure during caesarean section on postmenstrual spotting: economic evaluation alongside a randomised controlled trial.<h4>Objective</h4>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.<h4>Design</h4>Economic evaluation alongside a multicentre, double-blind, randomised controlled trial.<h4>Setting</h4>32 hospitals in the Netherlands, 2016-2018.<h4>Participants</h4>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.<h4>Interventions</h4>Single-layer unlocked uterine closure and double-layer unlocked uterine closure with the second layer imbricating the first.<h4>Main outcome measures</h4>Spotting days, quality-adjusted life-years (QALYs), and societal costs at 9 months of follow-up. Missing data were imputed using multiple imputation.<h4>Results</h4>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).<h4>Conclusion</h4>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.<h4>Trial registration number</h4>NTR5480/NL5380.2021-01-01T00:00:00Z2021 Jul2024-11-12T07:31:50.014Z2022-02-10T21:49:01.87ZS-EPMC82567413421559810.1136/bmjopen-2020-044340