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

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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.

Original languageEnglish
Article numbere044340
Pages (from-to)1-11
Number of pages11
JournalBMJ Open
Volume11
Issue number7
DOIs
Publication statusPublished - 2 Jul 2021

Bibliographical note

Publisher Copyright:
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

Copyright:
This record is sourced from MEDLINE/PubMed, a database of the U.S. National Library of Medicine

Funding

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. 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.

FundersFunder number
ZonMw843002605

    Keywords

    • health economics
    • maternal medicine
    • obstetrics
    • ultrasonography

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