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,
Eva Pajkrt,
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
Affiliations
Judith E Bosmans
Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, Netherlands
Daniela H Schippers
Wietske Hermes
Marieke Sueters
Eva Pajkrt
1 Obstetrics and Gynaecology, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands
Mireille N Bekker
Department of Obstetrics, Wilhelmina Children’s Hospital, University Medical Center Utrecht, Utrecht, Netherlands
WM van Baal
CAH Janssen
HCJ Scheepers
Sanne I. Stegwee
Obstetrics and Gynaecology, Amsterdam Reproduction & Development, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
Ângela J. Ben
Health Sciences, Amsterdam Public Health, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
Mohamed El Alili
Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands
Lucet F. van der Voet
Obstetrics and Gynaecology, Deventer Ziekenhuis, Deventer, the Netherlands
Christianne J.M. de Groot
Obstetrics and Gynaecology, Amsterdam Reproduction & Development, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
Judith E. Bosmans
Health Sciences, Amsterdam Public Health, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
Judith A.F. Huirne
Obstetrics and Gynaecology, Amsterdam Reproduction & Development, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
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
8 Department of Gynecology, Dijklander Hospital, Hoorn and Purmerend, The Netherlands
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.