Effectiveness and costs of non-invasive foetal RHD genotyping in rhesus-D negative mothers: a French multicentric two-arm study of 850 women View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2018-12-14

AUTHORS

Meryl Darlington, Bruno Carbonne, Agnès Mailloux, Yves Brossard, Annie Levy-Mozziconacci, Anne Cortey, Hassani Maoulida, Tabassome Simon, Alexandra Rousseau, Isabelle Durand-Zaleski

ABSTRACT

BackgroundThe determination of foetal Rhesus D (RHD) status allows appropriate use of IgRh prophylaxis by restricting its use to cases of RHD feto-maternal incompatibilities. There is a degree of uncertainty about the cost-effectiveness of foetal RHD determination, yet screening programs are being introduced into clinical practice in many countries.This paper evaluates the impact of non-invasive foetal Rhesus D (RHD) status determination on the costs of managing RHD-negative pregnant women and on the appropriate use of anti-D prophylaxis in a large sample of RHD-negative pregnant women using individual prospectively collected clinical and economic data.MethodsA prospective two-armed trial of RHD negative pregnant women was performed in 11 French Obstetric Departments. Non-invasive foetal RHD genotyping was performed before 26 weeks' gestation in the experimental arm whereas the control arm participants received usual care. The costs associated with patient management in relation to their RHD negative status (biological tests, anti-D prophylaxis and visits) were calculated from inclusion to the end of the postpartum period. The costs of hospital admissions during pregnancy and delivery were also determined.ResultsA total of 949 patients were included by 11 centres between 2009 and 2012, and 850 completed follow-up, including medical and biological monitoring. Patients were separated into two groups: the genotyping group (n=515) and the control group (n=335). The cost of the genotyping was estimated at 140 euros per test. The total mean cost per patient was estimated at €3,259 (SD ± 1,120) and €3,004 (SD ± 1,004) in the genotyping and control groups respectively. The cost of delivery represented three quarters of the total cost in both groups. The performance of managing appropriately RHD negative anti-D prophylaxis was 88% in the genotyping group, versus 65% in the control group. Using the costs related to RHD status (biological tests, anti-D immunoglobulin injections and visits) the incremental cost-effectiveness ratio (ICER) was calculated to be €578 for each percentage gain in women receiving appropriate management.ConclusionEarly knowledge of the RHD status of the foetus using non-invasive foetal RHD genotyping significantly improved the management of RHD negative pregnancies with a small increase in cost.Trial registrationClinical trials registry-NCT00832962–13 January 2009 - retrospectively registered. More... »

PAGES

496

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s12884-018-2114-5

DOI

http://dx.doi.org/10.1186/s12884-018-2114-5

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1110648735

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30547830


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    "description": "BackgroundThe determination of foetal Rhesus D (RHD) status allows appropriate use of IgRh prophylaxis by restricting its use to cases of RHD feto-maternal incompatibilities. There is a degree of uncertainty about the cost-effectiveness of foetal RHD determination, yet screening programs are being introduced into clinical practice in many countries.This paper evaluates the impact of non-invasive foetal Rhesus D (RHD) status determination on the costs of managing RHD-negative pregnant women and on the appropriate use of anti-D prophylaxis in a large sample of RHD-negative pregnant women using individual prospectively collected clinical and economic data.MethodsA prospective two-armed trial of RHD negative pregnant women was performed in 11 French Obstetric Departments. Non-invasive foetal RHD genotyping was performed before 26 weeks' gestation in the experimental arm whereas the control arm participants received usual care. The costs associated with patient management in relation to their RHD negative status (biological tests, anti-D prophylaxis and visits) were calculated from inclusion to the end of the postpartum period. The costs of hospital admissions during pregnancy and delivery were also determined.ResultsA total of 949 patients were included by 11 centres between 2009 and 2012, and 850 completed follow-up, including medical and biological monitoring. Patients were separated into two groups: the genotyping group (n=515) and the control group (n=335). The cost of the genotyping was estimated at 140 euros per test. The total mean cost per patient was estimated at \u20ac3,259 (SD \u00b1 1,120) and \u20ac3,004 (SD \u00b1 1,004) in the genotyping and control groups respectively. The cost of delivery represented three quarters of the total cost in both groups. The performance of managing appropriately RHD negative anti-D prophylaxis was 88% in the genotyping group, versus 65% in the control group. Using the costs related to RHD status (biological tests, anti-D immunoglobulin injections and visits) the incremental cost-effectiveness ratio (ICER) was calculated to be \u20ac578 for each percentage gain in women receiving appropriate management.ConclusionEarly knowledge of the RHD status of the foetus using non-invasive foetal RHD genotyping significantly improved the management of RHD negative pregnancies with a small increase in cost.Trial registrationClinical trials registry-NCT00832962\u201313 January 2009 - retrospectively registered.", 
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24 schema:description BackgroundThe determination of foetal Rhesus D (RHD) status allows appropriate use of IgRh prophylaxis by restricting its use to cases of RHD feto-maternal incompatibilities. There is a degree of uncertainty about the cost-effectiveness of foetal RHD determination, yet screening programs are being introduced into clinical practice in many countries.This paper evaluates the impact of non-invasive foetal Rhesus D (RHD) status determination on the costs of managing RHD-negative pregnant women and on the appropriate use of anti-D prophylaxis in a large sample of RHD-negative pregnant women using individual prospectively collected clinical and economic data.MethodsA prospective two-armed trial of RHD negative pregnant women was performed in 11 French Obstetric Departments. Non-invasive foetal RHD genotyping was performed before 26 weeks' gestation in the experimental arm whereas the control arm participants received usual care. The costs associated with patient management in relation to their RHD negative status (biological tests, anti-D prophylaxis and visits) were calculated from inclusion to the end of the postpartum period. The costs of hospital admissions during pregnancy and delivery were also determined.ResultsA total of 949 patients were included by 11 centres between 2009 and 2012, and 850 completed follow-up, including medical and biological monitoring. Patients were separated into two groups: the genotyping group (n=515) and the control group (n=335). The cost of the genotyping was estimated at 140 euros per test. The total mean cost per patient was estimated at €3,259 (SD ± 1,120) and €3,004 (SD ± 1,004) in the genotyping and control groups respectively. The cost of delivery represented three quarters of the total cost in both groups. The performance of managing appropriately RHD negative anti-D prophylaxis was 88% in the genotyping group, versus 65% in the control group. Using the costs related to RHD status (biological tests, anti-D immunoglobulin injections and visits) the incremental cost-effectiveness ratio (ICER) was calculated to be €578 for each percentage gain in women receiving appropriate management.ConclusionEarly knowledge of the RHD status of the foetus using non-invasive foetal RHD genotyping significantly improved the management of RHD negative pregnancies with a small increase in cost.Trial registrationClinical trials registry-NCT00832962–13 January 2009 - retrospectively registered.
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30 schema:keywords D status
31 Department
32 Obstetrics Department
33 RHD
34 ResultsA total
35 RhD status
36 RhD-negative pregnancies
37 RhD-negative pregnant women
38 RhD-negative status
39 Rhesus D status
40 admission
41 appropriate management
42 appropriate use
43 arm
44 arm participants
45 biological monitoring
46 care
47 cases
48 center
49 clinical practice
50 control arm participants
51 control group
52 cost
53 cost of delivery
54 cost-effectiveness ratio
55 countries
56 data
57 degree
58 degree of uncertainty
59 delivery
60 determination
61 economic data
62 effectiveness
63 end
64 euro
65 experimental arm
66 feto-maternal incompatibility
67 fetuses
68 foetal RHD
69 gain
70 genotyping
71 gestation
72 group
73 hospital admission
74 impact
75 inclusion
76 incompatibility
77 increase
78 incremental cost-effectiveness ratio
79 knowledge
80 large sample
81 management
82 mean cost
83 monitoring
84 mothers
85 negative mothers
86 negative pregnancy
87 negative pregnant women
88 negative status
89 non-invasive foetal RHD
90 paper
91 participants
92 patient management
93 patients
94 percentage gain
95 performance
96 period
97 postpartum period
98 practice
99 pregnancy
100 pregnant women
101 program
102 prophylaxis
103 quarter
104 ratio
105 relation
106 rhesus
107 samples
108 small increase
109 status
110 status determination
111 study
112 test
113 total
114 total cost
115 total mean cost
116 trials
117 two-arm study
118 two-armed trial
119 uncertainty
120 use
121 usual care
122 weeks' gestation
123 women
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