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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.

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.

SUBMITTER: Okeke Ogwulu CB

PROVIDER: S-EPMC7187468 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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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.

Okeke Ogwulu C B CB Goranitis I I Devall A J AJ Cheed V V Gallos I D ID Middleton L J LJ Harb H M HM Williams H M HM Eapen A A Daniels J P JP Ahmed A A Bender-Atik R R Bhatia K K Bottomley C C Brewin J J Choudhary M M Deb S S Duncan W C WC Ewer A K AK Hinshaw K K Holland T T Izzat F F Johns J J Lumsden M M Manda P P Norman J E JE Nunes N N Overton C E CE Kriedt K K Quenby S S Rao S S Ross J J Shahid A A Underwood M M Vaithilingham N N Watkins L L Wykes C C Horne A W AW Jurkovic D D Coomarasamy A A Roberts T E TE

BJOG : an international journal of obstetrics and gynaecology 20200130 6

<h4>Objectives</h4>To assess the cost-effectiveness of progesterone compared with placebo in preventing pregnancy loss in women with early pregnancy vaginal bleeding.<h4>Design</h4>Economic evaluation alongside a large multi-centre randomised placebo-controlled trial.<h4>Setting</h4>Forty-eight UK NHS early pregnancy units.<h4>Population</h4>Four thousand one hundred and fifty-three women aged 16-39 years with bleeding in early pregnancy and ultrasound evidence of an intrauterine sac.<h4>Methods ...[more]

PMID: 32003141

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Project description:BackgroundLifestyle interventions (diet, physical activity and/or behavioural) to optimise gestational weight gain can prevent adverse maternal outcomes such as gestational diabetes, pre-eclampsia and caesarean section.ObjectiveWe aimed to model the cost effectiveness of lifestyle interventions during pregnancy on reducing adverse maternal outcomes.MethodsDecision tree modelling was used to determine the cost effectiveness of lifestyle interventions compared with usual care on preventing cases of gestational diabetes and hypertensive disease in pregnancy. Participants were pregnant women receiving routine antenatal care in secondary and tertiary care hospitals. The main outcome measures were cases of gestational diabetes and/or hypertensive disease in pregnancy prevented, costs, and incremental cost-effectiveness ratios. Analysis was conducted from the perspective of the Australian healthcare system, with a time horizon of early pregnancy to discharge after birth.ResultsWomen in the intervention group were 2.25% less likely to have gestational diabetes and/or hypertensive disease in pregnancy (9.53%) compared with the control group (11.78%). Intervention costs were Australian dollars (AUD) 228 per person. Costs were AUD33 per person higher in the intervention group (AUD8281) than the control group (AUD8248). The incremental cost-effectiveness ratio was AUD1470 per case prevented. Sensitivity analysis showed that base-case results were robust. In the probabilistic sensitivity analysis, 44.8% of data points fell within the north-east quadrant, and 52.2% in the south-east quadrant (cost saving), with a 95% confidence interval ranging from AUD - 50,018 to 32,779 per case prevented.ConclusionsWhile there is no formally accepted cost-effectiveness threshold for willingness-to-pay to prevent an adverse maternal event, the cost per person receiving a lifestyle intervention compared with controls was close to neutral, and therefore likely to be cost effective. Exploration of the cost effectiveness of different lifestyle delivery modes across various models of antenatal care is now required. Future cost-effectiveness studies should investigate longer time horizons, quality-adjusted life-years and productivity loss.Trial registrationNot applicable.

Project description:ObjectiveTo determine the accuracy with which a single progesterone measurement in early pregnancy discriminates between viable and non-viable pregnancy.DesignSystematic review and meta-analysis of diagnostic accuracy studies.Data sourcesMedline, Embase, CINAHL, Web of Science, ProQuest, Conference Proceedings Citation Index, and the Cochrane Library from inception until April 2012, plus reference lists of relevant studies.Study selectionStudies were selected on the basis of participants (women with spontaneous pregnancy of less than 14 weeks of gestation); test (single serum progesterone measurement); outcome (viable intrauterine pregnancy, miscarriage, or ectopic pregnancy) diagnosed on the basis of combinations of pregnancy test, ultrasound scan, laparoscopy, and histological examination; design (cohort studies of test accuracy); and sufficient data being reported.Results26 cohort studies, including 9436 pregnant women, were included, consisting of 7 studies in women with symptoms and inconclusive ultrasound assessment and 19 studies in women with symptoms alone. Among women with symptoms and inconclusive ultrasound assessments, the progesterone test (5 studies with 1998 participants and cut-off values from 3.2 to 6 ng/mL) predicted a non-viable pregnancy with pooled sensitivity of 74.6% (95% confidence interval 50.6% to 89.4%), specificity of 98.4% (90.9% to 99.7%), positive likelihood ratio of 45 (7.1 to 289), and negative likelihood ratio of 0.26 (0.12 to 0.57). The median prevalence of a non-viable pregnancy was 73.2%, and the probability of a non-viable pregnancy was raised to 99.2% if the progesterone was low. For women with symptoms alone, the progesterone test had a higher specificity when a threshold of 10 ng/mL was used (9 studies with 4689 participants) and predicted a non-viable pregnancy with pooled sensitivity of 66.5% (53.6% to 77.4%), specificity of 96.3% (91.1% to 98.5%), positive likelihood ratio of 18 (7.2 to 45), and negative likelihood ratio of 0.35 (0.24 to 0.50). The probability of a non-viable pregnancy was raised from 62.9% to 96.8%.ConclusionA single progesterone measurement for women in early pregnancy presenting with bleeding or pain and inconclusive ultrasound assessments can rule out a viable pregnancy.

Dataset Information

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

Publications

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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