BMJ Open (Jul 2021)

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

  • Judith E Bosmans,
  • Daniela H Schippers,
  • Wietske Hermes,
  • Marieke Sueters,
  • Mireille N Bekker,
  • WM van Baal,
  • CAH Janssen,
  • HCJ Scheepers,
  • Sanne I. Stegwee,
  • Ângela J. Ben,
  • Mohamed El Alili,
  • Lucet F. van der Voet,
  • Christianne J.M. de Groot,
  • Judith E. Bosmans,
  • Judith A.F. Huirne,
  • Erik van Beek,
  • Ângela Jornada Ben,
  • Karin de Boer,
  • Elisabeth MA Boormans,
  • Hugo WF van Eijndhoven,
  • Mohamed El Alili,
  • AH Feitsma,
  • Christianne JM de Groot,
  • Majoie Hemelaar,
  • Wouter JK Hehenkamp,
  • Esther Hink,
  • Judith AF Huirne,
  • Anjoke JM Huisjes,
  • Kitty Kapiteijn,
  • Mesrure Kaplan,
  • Paul JM van Kesteren,
  • Judith OEH van Laar,
  • Josje Langenveld,
  • Wouter J Meijer,
  • Angèle LM Oei,
  • Dimitri NM Papatsonis,
  • Celine M Radder,
  • Robbert JP Rijnders,
  • Nico WE Schuitemaker,
  • Sanne I Stegwee,
  • Harry Visser,
  • Huib AAM van Vliet,
  • LHM de Vleeschouwer,
  • Lucet F van der Voet

DOI
https://doi.org/10.1136/bmjopen-2020-044340
Journal volume & issue
Vol. 11, no. 7

Abstract

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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.