Multicenter Study

. 2020 May;127(6):757-767.

doi: 10.1111/1471-0528.16068. Epub 2020 Jan 30.

The cost-effectiveness of progesterone in preventing miscarriages in women with early pregnancy bleeding: an economic evaluation based on the PRISM trial

C B Okeke Ogwulu¹, I Goranitis^{1

2}, A J Devall³, V Cheed⁴, I D Gallos³, L J Middleton⁴, H M Harb³, H M Williams³, A Eapen⁵, J P Daniels⁶, A Ahmed⁷, R Bender-Atik⁸, K Bhatia⁹, C Bottomley¹⁰, J Brewin¹¹, M Choudhary¹², S Deb¹³, W C Duncan¹⁴, A K Ewer³, K Hinshaw⁷, T Holland¹⁵, F Izzat¹⁶, J Johns¹⁷, M Lumsden¹⁸, P Manda¹⁹, J E Norman²⁰, N Nunes²¹, C E Overton²², K Kriedt¹⁰, S Quenby²³, S Rao²⁴, J Ross¹⁸, A Shahid²⁵, M Underwood²⁶, N Vaithilingham²⁷, L Watkins²⁸, C Wykes²⁹, A W Horne¹⁴, D Jurkovic¹⁰, A Coomarasamy³, T E Roberts¹

Affiliations

¹ Health Economics Unit, College of Medical and Dental Sciences, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
² Health Economics Unit, Centre for Health Policy, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Vic., Australia.
³ College of Medical and Dental Sciences, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.
⁴ College of Medical and Dental Sciences, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
⁵ Carver College of Medicine, University of Iowa Health Care, Iowa City, IA, USA.
⁶ Faculty of Medicine & Health Sciences, Queen's Medical Centre, University of Nottingham, Nottingham, UK.
⁷ Sunderland Royal Hospital, City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.
⁸ The Miscarriage Association, Wakefield, UK.
⁹ Burnley General Hospital, East Lancashire Hospitals NHS Trust, Burnley, UK.
¹⁰ University College Hospital, University College London Hospitals NHS Foundation Trust, London, UK.
¹¹ Tommy's Charity, London, UK.
¹² Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
¹³ Queen's Medical Centre, Nottingham University Hospitals NHS Trust, Nottingham, UK.
¹⁴ MRC Centre for Reproductive Health, the Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.
¹⁵ Guy's and St Thomas' Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK.
¹⁶ University Hospital Coventry, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.
¹⁷ Kings College Hospital, King's College Hospital NHS Foundation Trust, London, UK.
¹⁸ Academic Unit of Reproductive and Maternal Medicine, University of Glasgow, Glasgow, UK.
¹⁹ James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.
²⁰ Faculty of Health Sciences, University of Bristol, Bristol, UK.
²¹ West Middlesex University Hospital, Chelsea and Westminster Hospital NHS Foundation Trust, Isleworth, UK.
²² St Michael's Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
²³ Biomedical Research Unit in Reproductive Health, University of Warwick, Warwick, UK.
²⁴ Whiston Hospital, St Helen's and Knowsley Teaching Hospitals NHS Trust, Whiston, Prescot, UK.
²⁵ Whipps Cross Hospital, Barts Health NHS Trust, Leytonstone, London, UK.
²⁶ Princess Royal Hospital, Shrewsbury and Telford Hospital NHS Trust, Apley, Telford, UK.
²⁷ Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital, Cosham, Portsmouth, UK.
²⁸ Liverpool Women's Hospital, Liverpool Women's NHS Foundation Trust, Liverpool Women's Hospital, Liverpool, UK.
²⁹ East Surrey Hospital, Surrey and Sussex Healthcare NHS Trust, Redhill, UK.

PMID: 32003141
PMCID: PMC7187468
DOI: 10.1111/1471-0528.16068

Multicenter Study

The cost-effectiveness of progesterone in preventing miscarriages in women with early pregnancy bleeding: an economic evaluation based on the PRISM trial

C B Okeke Ogwulu et al. BJOG. 2020 May.

. 2020 May;127(6):757-767.

doi: 10.1111/1471-0528.16068. Epub 2020 Jan 30.

Authors

Affiliations

¹ Health Economics Unit, College of Medical and Dental Sciences, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
² Health Economics Unit, Centre for Health Policy, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Vic., Australia.
³ College of Medical and Dental Sciences, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.
⁴ College of Medical and Dental Sciences, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
⁵ Carver College of Medicine, University of Iowa Health Care, Iowa City, IA, USA.
⁶ Faculty of Medicine & Health Sciences, Queen's Medical Centre, University of Nottingham, Nottingham, UK.
⁷ Sunderland Royal Hospital, City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.
⁸ The Miscarriage Association, Wakefield, UK.
⁹ Burnley General Hospital, East Lancashire Hospitals NHS Trust, Burnley, UK.
¹⁰ University College Hospital, University College London Hospitals NHS Foundation Trust, London, UK.
¹¹ Tommy's Charity, London, UK.
¹² Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
¹³ Queen's Medical Centre, Nottingham University Hospitals NHS Trust, Nottingham, UK.
¹⁴ MRC Centre for Reproductive Health, the Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.
¹⁵ Guy's and St Thomas' Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK.
¹⁶ University Hospital Coventry, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.
¹⁷ Kings College Hospital, King's College Hospital NHS Foundation Trust, London, UK.
¹⁸ Academic Unit of Reproductive and Maternal Medicine, University of Glasgow, Glasgow, UK.
¹⁹ James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.
²⁰ Faculty of Health Sciences, University of Bristol, Bristol, UK.
²¹ West Middlesex University Hospital, Chelsea and Westminster Hospital NHS Foundation Trust, Isleworth, UK.
²² St Michael's Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
²³ Biomedical Research Unit in Reproductive Health, University of Warwick, Warwick, UK.
²⁴ Whiston Hospital, St Helen's and Knowsley Teaching Hospitals NHS Trust, Whiston, Prescot, UK.
²⁵ Whipps Cross Hospital, Barts Health NHS Trust, Leytonstone, London, UK.
²⁶ Princess Royal Hospital, Shrewsbury and Telford Hospital NHS Trust, Apley, Telford, UK.
²⁷ Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital, Cosham, Portsmouth, UK.
²⁸ Liverpool Women's Hospital, Liverpool Women's NHS Foundation Trust, Liverpool Women's Hospital, Liverpool, UK.
²⁹ East Surrey Hospital, Surrey and Sussex Healthcare NHS Trust, Redhill, UK.

PMID: 32003141
PMCID: PMC7187468
DOI: 10.1111/1471-0528.16068

Abstract

Objectives: To assess the cost-effectiveness of progesterone compared with placebo in preventing pregnancy loss in women with early pregnancy vaginal bleeding.

Design: Economic evaluation alongside a large multi-centre randomised placebo-controlled trial.

Setting: Forty-eight UK NHS early pregnancy units.

Population: Four thousand one hundred and fifty-three women aged 16-39 years with bleeding in early pregnancy and ultrasound evidence of an intrauterine sac.

Methods: An incremental cost-effectiveness analysis was performed from National Health Service (NHS) and NHS and Personal Social Services perspectives. Subgroup analyses were carried out on women with one or more and three or more previous miscarriages.

Main outcome measures: Cost per additional live birth at ≥34 weeks of gestation.

Results: Progesterone intervention led to an effect difference of 0.022 (95% CI -0.004 to 0.050) in the trial. The mean cost per woman in the progesterone group was £76 (95% CI -£559 to £711) more than the mean cost in the placebo group. The incremental cost-effectiveness ratio for progesterone compared with placebo was £3305 per additional live birth. For women with at least one previous miscarriage, progesterone was more effective than placebo with an effect difference of 0.055 (95% CI 0.014-0.096) and this was associated with a cost saving of £322 (95% CI -£1318 to £673).

Conclusions: The results suggest that progesterone is associated with a small positive impact and a small additional cost. Both subgroup analyses were more favourable, especially for women who had one or more previous miscarriages. Given available evidence, progesterone is likely to be a cost-effective intervention, particularly for women with previous miscarriage(s).

Tweetable abstract: Progesterone treatment is likely to be cost-effective in women with early pregnancy bleeding and a history of miscarriage.

Keywords: Cost-effectiveness; economic evaluation; miscarriage; progesterone.

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Figures

**Figure 1**
Cost‐effectiveness plane for the base‐case analysis.

**Figure 2**
Cost‐effectiveness acceptability curve for the base‐case analysis.

See this image and copyright information in PMC

References

1. Wilcox AJ. Fertility and Pregnancy: An Epidemiologic Perspective. Oxford: Oxford University Press; 2010.
1. Wilson R, Jenkins C, Miller H, McInnes IB, Moore J, McLean MA, et al. Abnormal cytokine levels in non‐pregnant women with a history of recurrent miscarriage. Eur J Obstet Gynecol Reprod Biol 2004;115:51–4. - PubMed
1. Jurkovic D, Overton C, Bender‐Atik R. Diagnosis and management of first‐trimester miscarriage. BMJ 2013;346:f3676. - PubMed
1. Regan L, Rai R. Epidemiology and the medical causes of miscarriage. Best Pract Res Clin Obstet Gynaecol 2000;14:839–54. - PubMed
1. Kong G, Chung T, Lai B, Lok I. Gender comparison of psychological reaction after miscarriage—a 1‐year longitudinal study. BJOG 2010;117:1211–19. - PubMed

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The cost-effectiveness of progesterone in preventing miscarriages in women with early pregnancy bleeding: an economic evaluation based on the PRISM trial

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The cost-effectiveness of progesterone in preventing miscarriages in women with early pregnancy bleeding: an economic evaluation based on the PRISM trial

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