Evidence map›Paper›PMID 30547830›Full record

Trial reportBMC pregnancy and childbirth2018

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

Meryl Darlington, Bruno Carbonne, Agnès Mailloux, Yves Brossard, Annie Levy-Mozziconacci, Anne Cortey, Hassani Maoulida, Tabassome Simon, Alexandra Rousseau, Isabelle Durand-Zaleski and 1 more

Registry-linked trialOpen access · goldAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in BMC pregnancy and childbirth, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00832962 (Effectiveness of Routine Fetal RhD Genotyping for RhD- Pregnant Women), which is not on this map. Cited by 3 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 2 pooled it
1.6field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00832962 completednot on this map

Effectiveness of Routine Fetal RhD Genotyping for RhD- Pregnant Women

TypeobservationalSponsorAssistance Publique - Hôpitaux de ParisRan2009 to 2013Enrolled2,532ConditionsRhesus Negative Pregnant WomenArmsGenotyping, Usual prophylaxis
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 1 country.

Meryl DarlingtonAP-HP Health Economics Clinical Research Platform (URCEco), Hotel Dieu, Place de Parvis, 75004, Paris, France. meryl.darlington@urc-eco.fr.ORCID http://orcid.org/0000-0001-8029-1925
Bruno CarbonneAP-HP, Hôpital Saint Antoine, 184 Rue du Faubourg Saint-Antoine, 75012, Paris, France.
Agnès MaillouxUnité fonctionnelle biologique du centre national de référence en hémobiologie périnatale (CNRHP), Hôpital Saint Antoine, (AP-HP), 184 rue du Faubourg Saint-Antoine, 75012, Paris, France.
Yves BrossardUnité fonctionnelle biologique du centre national de référence en hémobiologie périnatale (CNRHP), Hôpital Saint Antoine, (AP-HP), 184 rue du Faubourg Saint-Antoine, 75012, Paris, France.
Annie Levy-MozziconacciAP-HM, Hôpital Nord, Chemin des Bourrely, 13915, Marseille cedex 20, France.
Anne CorteyUnité fonctionnelle clinique du centre national de référence en hémobiologie périnatale (CNRHP), Hôpital Trousseau, (AP-HP), 26 avenue du Dr Arnold-Netter, 75012, Paris, France.
Hassani MaoulidaAP-HP Health Economics Clinical Research Platform (URCEco), Hotel Dieu, Place de Parvis, 75004, Paris, France.
Tabassome SimonAP-HP, Unité de Recherche Clinique de l'Est Parisien (URC-Est), Hôpital Saint Antoine, 184 Rue du Faubourg Saint-Antoine, 75012, Paris, France.
Alexandra RousseauAP-HP, Unité de Recherche Clinique de l'Est Parisien (URC-Est), Hôpital Saint Antoine, 184 Rue du Faubourg Saint-Antoine, 75012, Paris, France.
Isabelle Durand-ZaleskiAP-HP Health Economics Clinical Research Platform (URCEco), Hotel Dieu, Place de Parvis, 75004, Paris, France.
GENIFERH1 Study Group
Sorbonne Université · FRAssistance Publique – Hôpitaux de Paris · FRHôpital Cochin · FRUniversité Paris Cité · FR

Funding

French Ministry of Health IC060673
6 · The paper itself

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.

Indexed as

Genotyping TechniquesPrenatal CareRh IsoimmunizationCost-Benefit AnalysisFemaleFetusFranceGenotypeHumansImmunologic FactorsPregnancyPregnancy OutcomePrenatal DiagnosisRh-Hr Blood-Group SystemRho(D) Immune GlobulinImmunologic FactorsRh-Hr Blood-Group SystemRHO(D) antibodyRho(D) Immune GlobulinAnti-D immunoglobulinCost-effectivenessCost evaluationNon-invasive foetal RHD genotyping

Identifiers

PMID30547830
PMCPMC6295078
OpenAlexW2903784310

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.