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The use of Rho(D) immune globulin in Rh-negative pregnant women has become standard of care, but many practicing clinicians do not know the dosing recommendations for this essential medication. In this article, we describe a case of a 15-year-old girl who presented with intrauterine fetal demise and was found to have massive fetomaternal hemorrhage. Kleihauer-Betke testing results indicated nearly 460 mL of fetal blood in the maternal circulation. The patient ultimately received 4800 µg of Rho(D) immune globulin, a dose that required close coordination with the obstetrical service and pharmacy. Although this is an unusual case of large-volume, potentially chronic, fetomaternal hemorrhage, it is also an excellent illustration of the principles for diagnosing this condition, as well as providing dosing guidelines for Rho(D) immunoglobulin to prevent alloimmunization. [ABSTRACT FROM AUTHOR]

Blood transfusion is life-saving in massive hemorrhage. Before pre-transfusion tests with ABO and RhD typing results are available, O RhD negative packed red blood cell (PRBC) units are used without cross-matching in emergency. RhD negative girls and women of child-bearing age should always receive RhD negative blood transfusions to prevent RhD-alloimmunization because anti-D-related hemolytic disease of fetus and newborn (HDFN) can result in mild to severe anemia, and in a worst-case scenario death of an RhD positive fetus and/or newborn. However, "wrong blood to wrong patient" happens unintentionally. Here we report an emergency blood transfusion with one unit of RhD positive PRBCs to an RhD negative young woman when estimated blood loss was 2500 mL during delivery and surgical removal of retained placenta. Realizing the mistake, management with high dose anti-D immunoglobulin (Ig) was initiated to remove the RhD positive red blood cells (RBCs) from the patient's circulation. Such mitigation is recommended only for girls and women of child-bearing age. Follow-up was performed by flow cytometry until RhD positive RBCs were no longer detected. Ten months after the delivery, antibody screening was negative. However, we still do not know whether we managed to prevent RhD-alloimmunization. [ABSTRACT FROM AUTHOR]

Background: Rh(D) alloimmunization prophylaxis should be administered to unsensitized Rh(D)-negative pregnant women. A routine antenatal dose and a postpartum dose for women that delivered an Rh(D)-positive neonate are recommended. Due to a very low prevalence of Rh(D)-negative blood type in Thai population, awareness of this specific management may be lacking. Objective: To determine the proportion of unsensitized Rh(D)-negative pregnant women that delivered at Siriraj Hospital who received a complete course of anti-D immunoglobulin and to determine the factors associated with the failure to achieve a complete administration as well as pregnancy and neonatal outcomes. Materials and Methods: Medical records of 133 unsensitized Rh(D)-negative pregnant women were reviewed to determine the proportion of cases receiving a complete anti-D prophylaxis. Possible reasons for missing anti-D administration were postulated. Comparison between cases receiving and not receiving antenatal anti-D prophylaxis was performed in terms of associated factors. Pregnancy and neonatal outcomes were compared between women who received complete prophylaxis and those who did not. Results: A complete anti-D prophylaxis was obtained in 71.4% of the women with antenatal dose given to 78.2%. Late antenatal care (OR 2.6, 95% CI 1.4 to 4.9) and late or no antenatal care at Siriraj Hospital (OR 7.1, 95% CI 2.8 to 17.9) were associated with missing antenatal anti-D administration. Desire for tubal sterilization and positive maternal Rh(D)-antibody in the third trimester appeared to be the causes of postpartum dose omission. Pregnancy and neonatal outcomes were comparable between women receiving and not receiving a complete anti-D prophylaxis. Conclusion: The proportion of unsensitized Rh(D)-negative pregnant women delivering at Siriraj Hospital who received a complete anti-D prophylaxis was 71.4%. Late antenatal care, late or no antenatal care at Siriraj Hospital, desire for tubal sterilization, and positive maternal Rh(D)-antibody in the third trimester were associated with the incomplete Rh(D) alloimmunization prophylaxis. [ABSTRACT FROM AUTHOR]

Introduction: Hepatitis C virus (HCV) infection is a serious health problem. It is a major contributor to end-stage liver disease. Worldwide, 1–8% of all pregnant women were infected. Women with viral hepatitis may be at an increased risk of pregnancy complications. There are several obstetrics intervention acts as risk factors, which are specific to women pertaining the HCV infection; anti-D immunoglobulin (Ig) therapy may be one of them. Our objectives were to estimate the prevalence of HCV antibodies (anti-HCV), RNA, and genotype distribution among women with anti-D Ig therapy. Materials and methods: A cross sectional study was conducted. A sample of 154 Rhesus negative (Rh − ve) pregnant women regardless of the anti-D Ig therapy was collected. Anti-HCV were tested using third generation enzyme immunoassay (EIA-3) and immunoblot assay (Lia Tek-111), subsequently. In addition, 89 serum samples were subjected to molecular analysis using RT-PCR and DNA enzyme immunoassay (DEIA) method for the detection of HCV-RNA and genotypes. Results: Anti-HCV, and HCV-RNA seroprevalence were significantly higher (17.1, 35.5%) among women with anti-D Ig than their counter group (6.4, 13.16%), p =.038,.018, respectively. Significant direct positive dose response correlation (r = 0.78, p =.005) had been seen between number of anti-D Ig therapy and anti-HCV seropositive rate. Anti-D Ig therapy act as a risk factor (odds ratio (OR) = 3.01, 95%CI: 1.01–8.9) especially from the third dose onward. Women with anti-D Ig therapy were at higher risk (3.6 times more) of positive HCV-RNA (OR =3.6, 95%CI =1.19–10.837). Genotype HCV-1b showed higher prevalent (52.9%) among the recipients of anti-D Ig therapy while genotype HCV-3a (6.6%) was the lowest. Conclusions: Our study showed that Anti-D immunoglobulin therapy acts as a risk factor for acquiring HCV infection. Screening for HCV should be recommended for all recipients of anti-D Ig. Not only HCV antibodies but HCV-RNA detection being recommended for the diagnosis of HCV infection. A brief rational: Pregnant women with HCV infection are at risk of adverse obstetric outcome. Anti-D Ig therapy may be a risk factor for HCV infection. Hence, we conducted a cross sectional study with the objectives to estimate the prevalence of HCV antibodies (anti-HCV), RNA, and genotype distribution among women with anti-D Ig therapy. We found that anti-HCV and HCV-RNA seroprevalence were significantly higher in women with anti-D Ig. In addition, women with anti-D Ig therapy were 3.6 times more at risk of positive HCV-RNA with genotype HCV-1b showed higher prevalence. Therefore, anti-D Ig therapy is a risk factor for acquiring HCV infection and we recommend screening for HCV for all recipients of anti-D Ig. In addition, the diagnosis of HCV infection, should be made with HCV antibodies and HCV-RNA detection. [ABSTRACT FROM AUTHOR]

Background and Objectives: The purpose of the study was to evaluate a lyophilized anti‐D immunoglobulin preparation to serve as a replacement WHO International Standard for the calibration of potency assays of anti‐D immunoglobulin products. Such products are used to prevent haemolytic disease of the foetus and newborn due to maternal alloanti‐D. Materials and Methods: The candidate 3rd International Standard for anti‐D immunoglobulin (16/332) was evaluated and calibrated against the 2nd International Standard for anti‐D immunoglobulin (01/572), along with a coded duplicate, a second candidate preparation (16/278) and a comparability sample (16/272) in an international collaborative study. Twenty of 21 laboratories in 15 countries performed one or more of the three European Pharmacopoeia reference methods. Results: The overall geometric mean potency (from all methods) of the candidate 3rd International Standard, 16/332, was 296·6 IU/ampoule, with inter‐laboratory variability, expressed as % GCV, of 4·7%. SE‐HPLC of the immunoglobulin preparations demonstrated combined monomeric and dimeric IgG peak areas of >95% for all samples. Accelerated stability studies have shown both 16/332 and 16/278 to be very stable for long‐term storage at −20°C. Conclusions: Preparation 16/332 was established by the World Health Organisation Expert Committee on Biological Standardization as the 3rd International Standard for anti‐D immunoglobulin with an assigned potency of 297 IU/ampoule. [ABSTRACT FROM AUTHOR]

Introduction: Hepatitis C virus (HCV) infection is a serious health problem. It is a major contributor to end-stage liver disease. Worldwide, 1-8% of all pregnant women were infected. Women with viral hepatitis may be at an increased risk of pregnancy complications. There are several obstetrics intervention acts as risk factors, which are specific to women pertaining the HCV infection; anti-D immunoglobulin (Ig) therapy may be one of them. Our objectives were to estimate the prevalence of HCV antibodies (anti-HCV), RNA, and genotype distribution among women with anti-D Ig therapy. Materials and methods: A cross sectional study was conducted. A sample of 154 Rhesus negative (Rh - ve) pregnant women regardless of the anti-D Ig therapy was collected. Anti-HCV were tested using third generation enzyme immunoassay (EIA-3) and immunoblot assay (Lia Tek-111), subsequently. In addition, 89 serum samples were subjected to molecular analysis using RT-PCR and DNA enzyme immunoassay (DEIA) method for the detection of HCV-RNA and genotypes. Results: Anti-HCV, and HCV-RNA seroprevalence were significantly higher (17.1, 35.5%) among women with anti-D Ig than their counter group (6.4, 13.16%), p = .038, .018, respectively. Significant direct positive dose response correlation (r = 0.78, p = .005) had been seen between number of anti-D Ig therapy and anti-HCV seropositive rate. Anti-D Ig therapy act as a risk factor (odds ratio (OR) = 3.01, 95%CI: 1.01-8.9) especially from the third dose onward. Women with anti-D Ig therapy were at higher risk (3.6 times more) of positive HCV-RNA (OR =3.6, 95%CI =1.19-10.837). Genotype HCV-1b showed higher prevalent (52.9%) among the recipients of anti-D Ig therapy while genotype HCV-3a (6.6%) was the lowest. Conclusions: Our study showed that Anti-D immunoglobulin therapy acts as a risk factor for acquiring HCV infection. Screening for HCV should be recommended for all recipients of anti-D Ig. Not only HCV antibodies but HCV-RNA detection being recommended for the diagnosis of HCV infection. A brief rational: Pregnant women with HCV infection are at risk of adverse obstetric outcome. Anti-D Ig therapy may be a risk factor for HCV infection. Hence, we conducted a cross sectional study with the objectives to estimate the prevalence of HCV antibodies (anti-HCV), RNA, and genotype distribution among women with anti-D Ig therapy. We found that anti-HCV and HCV-RNA seroprevalence were significantly higher in women with anti-D Ig. In addition, women with anti-D Ig therapy were 3.6 times more at risk of positive HCV-RNA with genotype HCV-1b showed higher prevalence. Therefore, anti-D Ig therapy is a risk factor for acquiring HCV infection and we recommend screening for HCV for all recipients of anti-D Ig. In addition, the diagnosis of HCV infection, should be made with HCV antibodies and HCV-RNA detection. [ABSTRACT FROM AUTHOR]

Objective The objective of this study was to compare national guidelines on the prevention of RhD alloimmunization. Study Design We performed a review of four national guidelines on prevention of alloimmunization from the American Congress of Obstetricians and Gynecologists, Royal Collegeof Obstetricians and Gynaecologists, Society of Obstetricians and Gynaecologists of Canada, and The Royal Australian and New Zealand College of Obstetricians and Gynaecologists. We compared the indications/contraindications, timing, dosing, formulation and route of anti-D immune globulin, and management of unique circumstances. The references were compared with regard to the number of randomized control trials, Cochrane Reviews, and systematic reviews/meta-analyses cited. Results Variation exists in recommendations on the timing and need for consent prior to routine antenatal anti-D immune globulin administration, prophylaxis for unique circumstances (e.g., threatened abortion < 12 weeks, complete molar pregnancy), and the use of cell-free fetal DNA testing for fetal RhD genotype. Conclusion These variations in recommendations reflect the heterogeneity of the literature on the prevention of alloimmunization and highlight the need for synthesis of evidence to create an international guideline on prevention of alloimmunization. This may improve safety, quality, optimize outcomes, and stimulate future trials. [ABSTRACT FROM AUTHOR]

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Background: Informed decision-making around anti-D immunoglobulin (Ig) is important but complex, requiring consideration of individual factors to reach the most appropriate choices for individual women. Aims: This research aimed to develop understanding of midwives' practices when offering anti-D Ig to RhD-negative women. Methods: A descriptive, qualitative study was used. Two focus groups were held with 11 midwife participants from two Scottish maternity units. Data were analysed using thematic analysis within a framework approach. Findings: When offering anti-D Ig, midwives were limited in their ability to fully engage with women in a process of individual informed decisionmaking, due partly to their own knowledge and understanding and partly to organisational culture and support. Conclusions: When interventions are recommended and offered routinely, it is challenging to extend the principles of woman-centred individualised care to facilitate meaningful decision-making. More effort is required to understand the difficulties faced by midwives. [ABSTRACT FROM AUTHOR]

The G antigen of Rh blood group system is present in almost all D-positive or C-positive red cells but absent from red cells lacking D and C antigens. The differentiation of anti-D and anti-C from anti-G is not necessary for routine transfusion; however, during pregnancy, it is important because anti-G can masquerade as anti-D and anti-C with initial antibody testing. The false presence of anti-D will exclude the patient from receiving anti-D immunoglobulin (RhIG) when the patient actually is a candidate for RhIG prophylaxis. Moreover, patients with positive anti-D or anti-G are at risk of developing hemolytic disease of the fetus and newborn and need close monitoring. Thus, proper identification allows the clinicians to manage patients properly. This case report highlights a rare case of anti-G together with anti-D and anti-C in a pregnant woman. This report disseminates knowledge on identification of anti-G and its importance in pregnant women. [ABSTRACT FROM AUTHOR]

Background: The purpose of this scoping review was to review the literature on healthcare provider provision of anti-D prophylaxis to RhD negative pregnant women in appropriate clinical situations in various healthcare settings. Methods: A scoping review framework was used to structure the process. The following databases were searched: CINAHL (EBSCO), EBM Reviews (OvidSP), Embase (OvidSP), Medline (OvidSP), and Web of Science (ISI). In addition, hand searching of article references was conducted. The search yielded 301 articles. Thirty-five articles remained for review after screening. Two team members reviewed each article using a detailed data collection sheet. A third reviewer was utilized if discrepancies occurred amongst reviewers. Results: The review process yielded 18 included articles. The majority of the studies were conducted in the United Kingdom. Of the 18 studies, 15 were retrospective studies. The articles were largely conducted in one institution. The articles with a focus on routine antenatal provision of anti-D immunoglobulin found that it was given 80 to 90% of the time. Postpartum provision of anti-D immunoglobulin had significantly higher results of 95-100%. The review found that the delivery of anti-D immunoglobulin to RhD negative pregnant women during situations of potential sensitizing events was suboptimal. Conclusions: The included articles examine the management of RhD negative pregnancies in various countries with existing national guidelines. The existing evidence indicates an opportunity for quality improvement in situations where potential sensitizing events are not at routine times in pregnancy, such as miscarriage or fetal demise early in pregnancy. Routine care for the prevention of RhD alloimmunization in pregnancy and postpartum appears to be fairly consistent. The paucity of recent literature in this area leads to a recommendation for further research. [ABSTRACT FROM AUTHOR]

Background: Since its introduction in the 1960s Anti-D immunoglobulin (Anti-D Ig) has been highly successful in reducing the incidence of haemolytic disease of the fetus and newborn (HDFN) and achieving improvements to maternal and fetal health. It has protected women from other invasive interventions during pregnancy and prevented deaths and damage amongst newborns and is a technology which has been adopted worldwide. Currently about one third of pregnant women with the blood group Rhesus D (RhD) negative in the UK (approximately 40,000 women per year in England and Wales), receive antenatal Anti-D Ig in pregnancy when they do not require it because they are carrying a RhD negative fetus. Since 1997, a test using cell free fetal DNA (cffDNA) in maternal blood has been developed to identify the genotype of the fetus and can be used to predict the fetal RhD blood group. Discussion: This paper considers whether it is ethically acceptable to continue administering antenatal Anti-D Ig to all RhD negative women when fetal RHD genotyping using maternal blood could identify those women who do not need this product. Summary: The antenatal administration of Anti-D Ig to a third of RhD negative pregnant women who carry a RhD negative fetus and therefore do not need it raises important ethical issues. If fetal RHD genotyping using maternal blood was offered to all RhD negative pregnant women it would assist them to make an informed choice about whether or not to have antenatal Anti-D Ig. [ABSTRACT FROM AUTHOR]

Background In patients with immune thrombocytopenia (ITP) who are Rhesus (Rh) D positive and who have not undergone splenectomy, the platelet count can be supported by anti-D Ig therapy. The response rate to plasma-derived intravenous anti-D at a dose of 50-75 μg/kg is 70-80% with an increase in platelet count after 24-72 h and duration for more than 21 days in 50% of responders. Rozrolimupab is a mixture of 25 fully human IgG1 recombinant monoclonal anti-D antibodies produced in CHO cells using a single-batch manufacturing strategy from a polyclonal cell bank. Materials & Methods The primary objective of the phase I/II study was to evaluate safety of a single dose in adult RhD-positive non-splenectomized patients with ITP. The secondary objectives were evaluations of the efficacy and appropriate dose for pivotal study. Patients were dosed with a single rozrolimupab dose ranging from 75 to 300 μg/kg, infused intravenously over 15-20 min. Results Rozrolimupab was well tolerated with no unexpected toxicities. The most frequent adverse events were headache, pyrexia, chills and fatigue. Serious adverse events were observed in nine patients, mainly in cohorts treated with doses of 200 μg/kg and 250 μg/kg, but only considered related to rozrolimupab in four patients: decrease in Hb (one patient), extravascular haemolysis (one patient) and transient increase of D-dimers (two patients). Hb decreased by ≥3.0 g/dl in six patients, but decrease by ≥5 g/dl was not observed. Seven patients required blood transfusions. Across all cohorts, 21 of 61 patients (34%) met the response criterion on day 7. The best response was noted in the 300 μg/kg dose cohort with response observed in eight of 13 patients (62%). Median time to response was 2 days and median duration of response was 14 days. Discussion The advantage of rozrolimupab over polyclonal anti-D immunoglobulin is unlimited supply, high and reproducible specificity and activity, and an improved safety profile. Conclusion In conclusion, our data suggest that rozrolimupab is safe, well tolerated and has efficacy similar to plasma-derived anti-D immunoglobulin in the treatment of primary ITP. [ABSTRACT FROM AUTHOR]

Objective To highlight the errors associated with the use of anti- D immunoglobulin in Rh D antigen-negative women, and their resultant clinical impact during and after pregnancy, and to suggest strategies to reduce these errors. Design Retrospective review of cumulative reporting to the UK confidential haemovigilance scheme, Serious Hazards of Transfusion ( SHOT), between 1996 and 2011. Setting Obstetric departments in the UK. Population Mothers who require anti- D immunoglobulin to prevent Rh D sensitisation during pregnancy or after birth. Methods Hospital transfusion teams reported adverse events to the SHOT database. Main outcome measures Reported number of events and their causes, and morbidity and mortality associated with errors. Results In 15 years of reporting, SHOT haemovigilance has shown a total of 1211 errors related to the administration of anti-D immunoglobulin, particularly regarding omission or late administration (157/249 or 63% reported in 2011). Anti-D immunoglobulin errors comprised 13.7% (249/1815) of all SHOT reports in 2011. Failure to recognise women who already have Rh D sensitisation occurred in 19 cases, and was followed by suboptimal monitoring of the pregnancy. Nine of the infants suffered haemolytic disease of the fetus and newborn ( HDFN): one resulted in neonatal death and three required red cell transfusion. Conclusions Babies as well as their mothers remain at risk from avoidable errors. More active attention at national and local levels to further education and training, particularly for midwives, is an absolute necessity. We recommend the use of a SHOT-devised anti- D administration flowchart, adapted locally into a checklist, to help reduce errors. [ABSTRACT FROM AUTHOR]

This study aimed to evaluate the efficacy, cost, and effects of anti-D immunoglobulin (anti-D Ig), methylprednisolone, or intravenous immunoglobulin (IVIG) therapy on the development of chronic disease in children who are Rh-positive with diagnosed immune thrombocytopenic purpura (ITP). Children with newly diagnosed ITP and platelet count <20,000/mm were prospectively randomized to treatment with anti-D Ig (50 μg/kg), methylprednisolone (2 mg/kg/day), or IVIG (0.4 g/kg/day, 5 days). Sixty children with a mean age of 6.7 years were divided into three equal groups. No difference was observed between platelet counts before treatment and on day 3 of treatment. However, platelet counts at day 7 were lower in the methylprednisolone group than in the IVIG group ( P = 0.03). In the anti-D Ig group, hemoglobin and hematocrit levels were significantly lower at the end of treatment ( P < 0.05). Chronic ITP developed in 30 % of the anti-D Ig group, 35 % of the methylprednisolone group, and 25 % of the IVIG group, but no significant difference was noted among the groups. The cost analysis revealed that the mean cost of IVIG was 7.4 times higher than anti-D Ig and 10.9 times higher than methylprednisolone. In the treatment of ITP in childhood, one 50 μg/kg dose of anti-D Ig has similar effects to IVIG and methylprednisolone. Among patients who were treated with anti-D Ig, serious anemia was not observed, and the cost of treatment was less than that of IVIG treatment. [ABSTRACT FROM AUTHOR]

Background: Idiopathic thrombocytopenic purpura (ITP) is an autoimmune disorder with a variable clinical course. Methods: A retrospective analysis was carried out of ITP patients presenting to a pediatric hematology-oncology department during a period of 20 years, with a focus on treatment and outcome. Results: One hundred and twenty-four cases were recorded (mean patient age, 8.4 years). Forty-nine children (39.5%) had platelet counts <10 000/µL at diagnosis. No episode of severe bleeding was observed. Peak incidence was observed during spring and summer. Respiratory infections proceeded in 58% of cases. Treatment consisted of i.v. immunoglobulin (IVIG) in 93 children at four dosing schedules. Sixteen children received corticosteroids, 10 children received anti-D immunoglobulin and 14 received no treatment. Recovery was observed in 67% of children on IVIG and in 50% on anti-D globulin. Eight patients did not respond initially and received corticosteroids. Three children with refractory thrombocytopenia received anti-CD20 (rituximab). Fourteen children (11%) had persistent/chronic disease. In 10 of them recovery was observed in 13 months-8 years. Splenectomy was performed in six children with resistant/chronic disease. Conclusion: ITP has a benign course in the majority of cases. Anti-D globulin can effectively be used as an alternative first-line treatment. Rituximab can successfully be used in refractory cases, while splenectomy has currently limited indications. [ABSTRACT FROM AUTHOR]

Objective. We present a pharmacokinetic study evaluating a single intramuscular dose of 250 μg anti-D immunoglobulin in the third trimester of pregnancy. The aim of the study was to determine the kinetic profile and duration of detectable levels of anti-D. Design. Prospective observational study. Setting. Antenatal outpatient clinic. Population. Healthy Rhesus D (RhD)-negative pregnant women with an RHD-positive fetus. Methods. Serial plasma anti-D quantitations following antenatal administration of anti-D immunoglobulin were performed using flow cytometry. Kinetic profiles for anti-D levels were generated from the concentration values at predetermined sampling time points. The half-lives were calculated by linear regression analysis. Main outcome measures. Time vs. concentration profile, half-life and anti-D concentration ≥1 ng/mL close to term. Results. The maximal plasma concentration of anti-D was usually seen at 3-10 days postinjection, with a median value of 25 ng/mL. The half-life varied between individuals, with a median of 23 days. We found detectable levels of anti-D IgG within two weeks of parturition in 11 of 12 women. Conclusions. The preparation of anti-D immunoglobulin used in the present study, if administrated in pregnancy week 28-30, is associated with detectable levels of anti-D in most women at the time of delivery. Although the half-time is 23 days, it is uncertain whether all mothers have adequate anti-D concentrations at term. Alternative strategies may be evaluated in the future, with repeated administration of antenatal prophylaxis at term rather than conventional postpartum administration of anti-D. [ABSTRACT FROM AUTHOR]

Abstract: The preparation anti-D immunoglobulin is an important therapy for both treatment and protection. Titer of anti-D immunoglobulin preparation is an important factor to determine the dose of treatment. Many methods are used to evaluate the titer of anti-D immunoglobulin preparation. One of the new methods developed recently is column agglutination test. To evaluate the BioVue column agglutination test, it was compared to conventional tube agglutination test using anti-D immunoglobulin preparations from three different producers, ten lots each. Results showed that the BioVue column agglutination test is comparable to conventional tube agglutination test but with much ease. In conclusion, the BioVue column agglutination test is accurate and easy to use in determination of anti-D titer for quality control purposes. [Copyright &y& Elsevier]

The aim of this study was to determine the compliance rates for women being offered routine antenatal anti-D prophylaxis in two obstetric units in the UK. Haemolytic disease of the newborn (HDN) is a potentially serious condition that can result in substantial morbidity and sometimes death. Current guidelines recommend that 500 IU anti-D immunoglobulin G (IgG) should be offered to all non-sensitized RhD-negative women at 28 and 34 weeks’ gestation in order to prevent the risk of RhD sensitization in pregnancy. Implementing guidance, however, remains a challenge. We conducted a retrospective audit of 207 RhD-negative, non-sensitized pregnant women attending obstetric units during 2004 to assess compliance with national guidance on the provision of antenatal anti-D prophylaxis. Informed consent for routine antenatal anti-D prophylaxis was documented for 185 of these women. In total, 86·5% of women received the two doses of anti-D IgG. The majority of women received their first and second doses within 1 week of 28 and 34 weeks’ gestation (87·0 and 86·0%, respectively). Accurate records of prophylactic anti-D IgG were maintained and updated. This audit demonstrates that the level of patient compliance with the two-dose regimen was high. [ABSTRACT FROM AUTHOR]

Background: Chronic idiopathic (immune) thrombocytopenic purpura (ITP) develops in approximately 20% of children with acute ITP. Six years ago, low-dose intravenous immunoglobulin (IVIG) treatment of childhood ITP was started at the Pediatric Hematology Unit, Ain Shams University, while intravenous anti-D has been introduced in Egypt in 2001. Objectives: To assess the efficacy and safety of intravenous anti-D compared to low-dose IVIG in the treatment of children with chronic ITP. Patients and Methods: This randomized trial comprised 34 patients with chronic ITP (18 boys and 16 girls) with recurrent bleeding episodes . Median age of the patients was 6.5 years, duration of thrombocytopenia was >6 months, and platelet count (PC) was <30 × 109/l (30 K). The patient cohort was divided into two subgroups: group A comprised 18 patients treated with anti-D in a dose of 50 μg/kg i.v. initially, and in 12 of them repeated doses (50 μg/kg) were given every 4 weeks, and group B consisted of 16 children who received IVIG in a dose of 250 mg/kg for 2 consecutive days. Bleeding manifestations, complete blood cell and reticulocyte counts were assessed at baseline and 3, 7, 14 and 28 days after infusion. Results: Clinically, more than 80% of the patients (82.3%) showed good control of bleeding. On day 3, 33.3% of group A versus 37.5% of group B, and on day 7: 66.6% of group A versus 75% of group B patients demonstrated a good response (PC >50 K and/or doubling of baseline PC). On days 14 and 21, no significant changes in PCs were observed between both groups. However, only 11.1% of group A and 12.5% of group B patients could maintain PC >100 K on day 28, while 38.8 versus 37.5% of group A and group B, respectively, still had PC ≥ double the initial count. The peak response to anti-D was noticed 7 and 14 days following infusion and to IVIG on days 3 and 7. Repeated doses of anti-D could maintain PC > 50 K (or > double the baseline PC) in 75% of patients 1 week after infusion, and in 60% of them by day 28, with good control of bleeding. Splenectomy was postponed and/or avoided in 4 (33.3%) patients on anti-D maintenance therapy who experienced recurrent severe bleeding episodes before starting therapy. The safety of anti-D was judged by the degree of intravascular hemolysis. The mean hemoglobin decrease was 0.8 ± 0.4 g/dl; in 61.1% of patients the Hb level dropped but none of them experienced a drop of more than 3 g/dl or required transfusion. Conclusion: Both single intravenous anti-D and low-dose IVIG effectively increased PC in children with chronic ITP at risk of bleeding or those with previous bleeding episodes. Repeated doses of anti-D could maintain PC above the critical values or double baseline counts in nearly two thirds of the patients showing good control of bleeding and may serve as an alternative to splenectomy in these patients. Copyright © 2006 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

In hepatitis C virus (HCV) infection, serum viral load is important in the prediction of therapeutic efficacy. However, factors that affect the viral load remain poorly understood. To identify viral genomic elements responsible for the viral load, we investigated samples from a population of Irish women who were iatrogenically infected from a single HCV source by administration of HCV 1b-contaminated anti-D immune globulin between 1977 and 1978 (Kenny-Walsh, N Engl J Med 1999; 340: 1228). About 15 patients were divided into two groups, viral load increasing group (11 patients) and decreasing group (4 patients). Pairs of sera were collected from each patient at interval between 1.1 and 5.8 years. Full-length sequences of HCV genome were determined, and analyzed for changes in each patient. Sliding window analysis showed that the decreasing group had significantly higher mutation rates in a short segment of NS5B region that may affect the activity of RNA-dependent RNA polymerase. By comparing each coding regions, significantly higher mutation numbers were accumulated in NS5A region in the increasing group than the decreasing group (0.92 vs 0.16 nucleotides/site/year, P = 0.021). The mutation in certain positions of the HCV genome may be determinant factors of the viral load in a relatively homogeneous patient population. [ABSTRACT FROM AUTHOR]

. Our objectives were to investigate possible overestimation of maternal anti-D due to co-existing anti-C and/or anti-G, and to confirm the presence of anti-D in plasma presumed to contain anti-D+C. We investigated 96 samples (from 22 antenatal patients and 74 blood donors) initially identified as containing anti-D+C using routine investigation procedures. Anti-D quantification was performed using an Astoria Pacific International 300 (API 300) continuous flow analyser with R1R1 and R2R2 reagent red cells. Where possible, samples were tested manually using a rare D+, C-, G- cell, to confirm the presence of anti-D. Fifty-two of 96 samples (11/22 antenatal patients and 41/74 blood donors) gave > 50% higher anti-D quantification results with R1R1 cells than with R2R2 cells. Anti-D was not detected using manual techniques in 16 of 73 samples tested (10/22 antenatal patients and 6/51 blood donors). Anti-D quantification using R1R1 reagent red cells may cause inaccurate estimation of anti-D levels, when anti-C and/or anti-G are present. Indeed, a significant number of cases, where apparent anti-D+C is identified, may contain only anti-C+G and lack an anti-D component. This may in turn lead to a failure to administer prophylactic anti-D immunoglobulin to RhD negative patients in cases where anti-D is not present, putting these patients at risk from immunization with possible consequences to future pregnancies. [ABSTRACT FROM AUTHOR]

Background: High-throughput non-invasive prenatal testing (NIPT) for fetal Rhesus D (RhD) status could avoid unnecessary treatment with anti-D immunoglobulin for RhD-negative women found to be carrying an RhD-negative fetus. We aimed to assess the diagnostic accuracy of high-throughput NIPT for fetal RhD status in RhD-negative women not known to be sensitized to the RhD antigen, by performing a systematic review and meta-analysis.Methods: Prospective cohort studies of high-throughput NIPT used to determine fetal RhD status were included. The eligible population were pregnant women who were RhD negative and not known to be sensitized to RhD antigen. The index test was high-throughput, NIPT cell-free fetal DNA tests of maternal plasma used to determine fetal RhD status. The reference standard considered was serologic cord blood testing at birth. Databases including MEDLINE, EMBASE, and Science Citation Index were searched up to February 2016. Two reviewers independently screened titles and abstracts and assessed full texts identified as potentially relevant. Risk of bias was assessed using QUADAS-2. The bivariate and hierarchical summary receiver-operating characteristic (HSROC) models were fitted to calculate summary estimates of sensitivity, specificity, false positive and false negative rates, and the associated 95% confidence intervals (CIs).Results: A total of 3921 references records were identified through electronic searches. Eight studies were included in the systematic review. Six studies were judged to be at low risk of bias. The HSROC models demonstrated high diagnostic performance of high-throughput NIPT testing for women tested at or after 11 weeks gestation. In the primary analysis for diagnostic accuracy, women with an inconclusive test result were treated as having tested positive. The false negative rate (incorrectly classed as RhD negative) was 0.34% (95% CI 0.15 to 0.76) and the false positive rate (incorrectly classed as RhD positive) was 3.86% (95% CI 2.54 to 5.82). There was limited evidence for non-white women and multiple pregnancies.Conclusions: High-throughput NIPT is sufficiently accurate to detect fetal RhD status in RhD-negative women and would considerably reduce unnecessary treatment with routine anti-D immunoglobulin. The applicability of these findings to non-white women and women with multiple pregnancies is uncertain. [ABSTRACT FROM AUTHOR]

Background: The 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.Methods: A 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.Results: A 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.Conclusion: Early 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 Registration: Clinical trials registry- NCT00832962 -13 January 2009 - retrospectively registered. [ABSTRACT FROM AUTHOR]