Study of compliance with a new, targeted antenatal D immunization prevention programme in Denmark

Damkjaer, Merete Berthu; Perslev, A.; Clausen, Frederik Banch; Dziegiel, Morten Hanefeld; Jørgensen, Finn Stener

doi:10.1111/j.1423-0410.2012.01602.x

Cited by 12 publications

(10 citation statements)

References 6 publications

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“…In contrast, in Denmark, as well as in Sweden, the prophylaxis program changed from postnatal prophylaxis only to targeted prenatal prophylaxis; thus, the routine administration of prenatal anti‐D was a new procedure. The Danish compliance for administering prenatal anti‐D was reported to be 86% within the first 6 months . This result is comparable with recent observations in Canada, where 85.7% of the RhD negative women received universal prenatal anti‐D .…”

Section: Prenatal Fetal Rhd Typingsupporting

confidence: 83%

Integration of noninvasive prenatal prediction of fetal blood group into clinical prenatal care

Clausen

2014

Prenat Diagn

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Incompatibility of red blood cell blood group antigens between a pregnant woman and her fetus can cause maternal immunization and, consequently, hemolytic disease of the fetus and newborn. Noninvasive prenatal testing of cell-free fetal DNA can be used to assess the risk of hemolytic disease of the fetus and newborn to fetuses of immunized women. Prediction of the fetal RhD type has been very successful and is now integrated into clinical practice to assist in the management of the pregnancies of RhD immunized women. In addition, noninvasive prediction of the fetal RhD type can be applied to guide targeted prenatal prophylaxis, thus avoiding unnecessary exposure to anti-D in pregnant women. The analytical aspect of noninvasive fetal RHD typing is very robust and accurate, and its routine utilization has demonstrated high sensitivities for fetal RHD detection. A high compliance with administering anti-D is essential for obtaining a clinical effect. Noninvasive fetal typing of RHC/c, RHE/e, and KEL may become more widely used in the future.

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Section: Prenatal Fetal Rhd Typingsupporting

confidence: 83%

Integration of noninvasive prenatal prediction of fetal blood group into clinical prenatal care

Clausen

2014

Prenat Diagn

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“…The GA was between 10–39 weeks as previously observed [46], which may result from the fact that this analysis and accompanying procedure was recently implemented. However, 73% of the samples were taken at GA 23–28 weeks, which is an improvement from the previously observed 63% figure from the first half of 2010 [46]. Nevertheless, our aim is for more than 95% of the samples to be collected at GA 23–28 weeks.…”

Section: Discussionmentioning

confidence: 72%

“…We were not able to obtain reliable information about compliance for the administration of the antenatal prophylaxis recommended by the results of antenatal screening. A previous minor-scale assessment of compliance from early 2010 showed a compliance of 86% [46], and this figure is anticipated to have improved. We roughly estimate that 90–95% of the expected samples arrive for antenatal RHD analysis [46].…”

Section: Discussionmentioning

confidence: 90%

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Pre-Analytical Conditions in Non-Invasive Prenatal Testing of Cell-Free Fetal RHD

et al. 2013

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BackgroundNon-invasive prenatal testing of cell-free fetal DNA (cffDNA) in maternal plasma can predict the fetal RhD type in D negative pregnant women. In Denmark, routine antenatal screening for the fetal RhD gene (RHD) directs the administration of antenatal anti-D prophylaxis only to women who carry an RhD positive fetus. Prophylaxis reduces the risk of immunization that may lead to hemolytic disease of the fetus and the newborn. The reliability of predicting the fetal RhD type depends on pre-analytical factors and assay sensitivity. We evaluated the testing setup in the Capital Region of Denmark, based on data from routine antenatal RHD screening.MethodsBlood samples were drawn at gestational age 25 weeks. DNA extracted from 1 mL of plasma was analyzed for fetal RHD using a duplex method for exon 7/10. We investigated the effect of blood sample transportation time (n = 110) and ambient outdoor temperatures (n = 1539) on the levels of cffDNA and total DNA. We compared two different quantification methods, the delta Ct method and a universal standard curve. PCR pipetting was compared on two systems (n = 104).ResultsThe cffDNA level was unaffected by blood sample transportation for up to 9 days and by ambient outdoor temperatures ranging from -10°C to 28°C during transport. The universal standard curve was applicable for cffDNA quantification. Identical levels of cffDNA were observed using the two automated PCR pipetting systems. We detected a mean of 100 fetal DNA copies/mL at a median gestational age of 25 weeks (range 10–39, n = 1317).ConclusionThe setup for real-time PCR-based, non-invasive prenatal testing of cffDNA in the Capital Region of Denmark is very robust. Our findings regarding the transportation of blood samples demonstrate the high stability of cffDNA. The applicability of a universal standard curve facilitates easy cffDNA quantification.

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“…We have retrospectively examined the compliance of the new program 2–5 months after its start [2]. We chose the largest obstetrical department in Denmark for the study.…”

Section: Resultsmentioning

confidence: 99%

Noninvasive prenatal screening for RHD: the 1st national antenatal directed anti‐D prophylaxis program – the Danish model or a guide to robust prediction of need of anti‐D

Dziegiel

2012

ISBT Science Series

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Background As of January 1, 2010, Denmark implemented a national antenatal directed anti‐D prophylaxis program. Prior to this, only postnatal prophylaxis directed by serology of cord blood was practiced. A preparatory work for modernization and optimization of fetal care was carried out by the National Board of Health with participation of leading obstetricians, specialists in fetal medicine, general practitioners, midwives, clinical immunologists and administrators. The promising results of non‐invasive prenatal diagnosis based on cell free fetal DNA enabled an antenatal directed use of anti‐D to those with a D positive fetus, thus eliminating approximately 40% of the antenatal use of anti‐D. The complete program now includes an antenatal RHD screening in gestational week 25, and a postnatal serological RhD typing of cord blood, in both instances followed by administration of anti‐D to those found positive. Aim The explicit aim of the RHD screening was to obtain the highest possible sensitivity to recommend anti‐D in all cases where it might be indicated whereas specificity was of secondary priority. Methods Health services in Denmark are organized in five regions; accordingly screening has been implemented in every region, each using its own in‐house screening methodology. However, all regions have implemented automated DNA purification and the assays are variations over a theme of multiple PCRs covering several exons. A control reaction for DNA purification is obligatory. However, a control for fetal DNA is not included. A working group with members from all regions has implemented a national scheme for quality control. Digital on‐line delivery of results to general practitioners, midwives and obstetricians is implemented in most regions thus cutting down on cost and time. Results The continuation of postnatal serology has allowed a quality control of RHD screening. During the first six months of screening only two false negative results occurred out of 2312 tested (0·087%) suggesting a sensitivity of 99·9%. Due to the sacrifice of specificity some unnecessary use of anti‐D occurred, 39 cases or 1·7%. Discussion The elimination of 38·3% of the use of anti‐D, that is unnecessary and the related clinical contacts balances the expenses for the screening. An unforeseen benefit of the screening has emerged. The availability of the antenatal RHD results at the time of delivery has simplified logistics and preliminary clinical action is taken based on the antenatal result. Only in the very rare occasions of a (false negative) discrepancy between antenatal and postnatal results is communication needed between laboratory, clinician, and patient. The challenge will be to maintain the high standards in a possible future setting without serology serving as a benchmark for quality control.

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Study of compliance with a new, targeted antenatal D immunization prevention programme in Denmark

Abstract: These compliance results are acceptable as they were obtained only a few months after the initiation of the new prophylaxis regime. However, suggestions to further improve compliance are presented.

Cited by 12 publications

References 6 publications

Integration of noninvasive prenatal prediction of fetal blood group into clinical prenatal care

Integration of noninvasive prenatal prediction of fetal blood group into clinical prenatal care

Pre-Analytical Conditions in Non-Invasive Prenatal Testing of Cell-Free Fetal RHD

Noninvasive prenatal screening for RHD: the 1st national antenatal directed anti‐D prophylaxis program – the Danish model or a guide to robust prediction of need of anti‐D

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