The cost of preterm labor and preterm birth for mothers with uncomplicated pregnancies and their infants in Italy: a retrospective cohort study

ABSTRACT

Background: Preterm labor (PTL)/preterm birth (PTB) impose significant burden on health-care systems. Women with uncomplicated pregnancies at risk of PTL/PTB have not been widely investigated, and published evidence on the costs of these women and their infants in Italy is absent. We aimed to describe women with uncomplicated pregnancies and associated costs for these women and their infants.

Methods: Data on women aged 12–44 years with uncomplicated pregnancies who delivered between 1 September 2009 and 31 December 2014 with PTL diagnosis alone or PTL and PTB were included from four Italian databases. Costs were examined during pregnancy, delivery, and 3 years after delivery for mothers and infants, overall and by gestational age (GA).

Results: A total of 3058 mothers linked to 3333 infants were included. Costs during pregnancy were €1777. Costs during delivery for PTL/PTB mothers and their infants ranged from €3174 (GA ≥37) to €21007 (GA <28). Combined maternal and infant costs appeared higher for births with lower GAs (<37) in the three-year follow-up.

Conclusions: In Italy, PTL/PTB mothers with uncomplicated pregnancies with infants at lower GAs appeared to incur higher medical costs compared to mothers with infants at higher GAs in all three time periods, with particularly marked differences found when considering mother and infant combined costs.

KEYWORDS:

• Preterm labor
• preterm birth
• Italy
• retrospective study
• cost analysis

Acknowledgments

The authors would like to thank Libby Black (formerly GlaxoSmithKline [GSK]) for her contributions during the early stages of the project, Alex Simpson (Evidera, London, UK) for his excellent contributions during the late stages of the project, Kim Poinsett-Holmes (Evidera, Bethesda, MD) for medical writing/editorial assistance and Grammati Sarri (Evidera, London, UK) for editorial assistance during the development of the manuscript.

Declaration of interest

E Merinopoulou and D Lambrelli are salaried employees of Evidera (Real-World Evidence), a research and consulting firm to the biopharma industry. V Blini, C Veronesi, S Buda, and LD Esposti are employees of CliCon Srl Health, Economics & Outcome Research. Both Evidera and CliCon Srl received payment from GSK for conducting this study, and Evidera (Medical Writing and Health Care Communication) has received payment for providing medical writing support. J Pimenta and S Pokras are employees and shareholders of GSK. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

E Merinopoulou (EM) and DL were responsible for conceptualization of the study design, produced the final results report, and were responsible for the quality assurance of all analyses and interpretation of the results. SP and JP conceived of the project idea, contributed to the study design and were responsible for the interpretation of the results. LDE and VB assisted with the study design and interpretation of results. LDE, CV, and SB analyzed the data. All authors critically reviewed the manuscript for intellectual content and approved the final version.

Ethics approval and consent to participate

Informed consent was not required for using encrypted retrospective information. This study was reported to the local ethics committee in each participating LHU, according to the Italian law regarding the conduct of observational analysis. (Agenzia Italiana del Farmaco)

The data were extracted by each LHU, and their databases were anonymized in full compliance with the Italian code of protection of personal data (Legislative Decree, 196/03). To guarantee patient privacy, each patient was assigned an anonymous patient number. The patient code in each database permitted electronic linking across all databases. No identifiers related to patients were provided to the researchers. All the results of the analyses were produced as aggregated summaries, which are not possible to assign, either directly or indirectly, to the individual patients. Informed consent is not required for using encrypted retrospective information. This study was notified to the local ethics committee in each participating LHU, according to the Italian law regarding the conduct of observational analysis [18]. The LHU Ethics Committees approved the study.

Availability of data and material

The data that support the findings of this study were provided by the Italian LHUs but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available.

Supplementary data

Supplemental data for this article can be accessed here

Notes

1. Despite imposing this requirement, it should be noted that no women were excluded based on having less than 9 months of continuous data.

2. In Italy, some particular circumstances such as disability (including depression), low income, or age entitle patients to co-pay fee exemption.

3. It should be noted that although we imposed this requirement, the rate of transfer between LHUs in Italy is very low.

Additional information

Funding

This work was funded by GSK (GSK study ID: HO-13-13781). GSK was involved in all stages of the study conduct and analysis. GSK also funded editorial support for the development and publishing of the present manuscript.