TY - JOUR
T1 - Cost-effectiveness of single-layer versus double-layer uterine closure during caesarean section on postmenstrual spotting
T2 - economic evaluation alongside a randomised controlled trial
AU - Stegwee, Sanne I.
AU - Ben, Angela J.
AU - El Alili, Mohamed
AU - van der Voet, Lucet F.
AU - de Groot, Christianne J. M.
AU - Bosmans, Judith E.
AU - Huirne, Judith A. F.
AU - van Baal, W. M.
AU - 2Close study group
AU - Scheepers, H.C.J.
N1 - Funding Information:
Funding This study was performed with funding from ZonMw: The Netherlands Organisation for Health Research and Development (project number 843002605). The funder of the study approved the study protocol.
Funding Information:
The Dutch gynaecological patients’ association agreed on the design of the study and the grant proposal for funding. They were not involved in outcome measures or recruitment, and they were not asked to give advice in the interpretation of the results. We will disseminate the study results to all participants, and to the public through popular science articles.
Publisher Copyright:
©
PY - 2021/7/2
Y1 - 2021/7/2
N2 - 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.
AB - 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.
KW - obstetrics
KW - maternal medicine
KW - ultrasonography
KW - health economics
KW - SCAR DEFECT
KW - SYMPTOMS
KW - OUTCOMES
KW - NICHE
KW - PREVALENCE
KW - FACTORIAL
KW - CORONIS
U2 - 10.1136/bmjopen-2020-044340
DO - 10.1136/bmjopen-2020-044340
M3 - Article
C2 - 34215598
SN - 2044-6055
VL - 11
JO - BMJ Open
JF - BMJ Open
IS - 7
M1 - e044340
ER -