A Multicenter, Randomized, Open-Label Trial Comparing the Efficacy and Safety of Monoclonal Anti-Rh (D) Immunoglobulin with Polyclonal Anti-Rh (D) Immunoglobulin for the Prevention of Maternal Rh-Isoimmunization (original) (raw)
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Indian Journal of Obstetrics and Gynecology Research, 2023
Background: AntiD ® is a recombinant anti-D immunoglobulin approved as an immunoprophylaxis treatment in Rh-negative mothers carrying an Rh-positive fetus. This study was conducted to assess the safety and tolerability of AntiD in clinical settings. Materials and Methods: This was a prospective, multicenter, phase IV, post-marketing safety study of AntiD. The study was conducted at 29 hospitals in India as per regulatory requirements. Three hundred eligible Rh-negative women were administered a single intramuscular dose of either 150 mcg or 300 mcg AntiD within 72 hours of a sensitizing event as per the approved indication. Safety and tolerability were evaluated based on the assessment of adverse events (AEs) and serious adverse events (SAEs) reported during the study. Results: Out of the 300 participants enrolled, 290 completed the study procedures. A total of 54 AEs and 34 treatment-emergent adverse events (TEAEs) were reported by 47 (15.7%) and 30 (10.0%) participants, respectively. Most reported TEAEs were mild, unrelated to the study drug, and were completely resolved during the study. Except for two participants with clinically significant hematological and urinalysis findings consistent with their underlying medical conditions, none of the participants exhibited abnormal clinical or laboratory parameters. Conclusion: Based on the assessment of the different safety parameters, AntiD administered at a dose of either 150 mcg or 300 mcg did not raise any new or significant safety concerns. The current study demonstrated that AntiD is well-tolerated and safe to use for anti-D prophylaxis as per product label indications for the prevention of Rh-isoimmunization in a clinical setting. This is an Open Access (OA) journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.
Risk factors for RhD immunisation despite antenatal and postnatal anti-D prophylaxis
BJOG: An International Journal of Obstetrics & Gynaecology, 2009
Objective To identify risk factors for Rhesus D (RhD) immunisation in pregnancy, despite adequate antenatal and postnatal anti-D prophylaxis in the previous pregnancy. To generate evidence for improved primary prevention by extra administration of anti-D Ig in the presence of a risk factor.
Acta Obstetricia et Gynecologica Scandinavica, 2013
Objective. To analyze the timing of Rhesus D (RhD) immunization in pregnancy and the consequences for the index pregnancy and for subsequent pregnancies to be able to optimize the design of antenatal screening and prevention programs. Design. Retrospective cohort study. Setting. Stockholm county, Sweden. Population. All RhD immunized pregnant women 1990-2008 before the introduction of routine antenatal anti-D prophylaxis. Methods. Data were collected from transfusion medicine registers and databases, medical records, the Swedish Medical Birth Register and the National Perinatal Quality Register and entered into a standardized database before analysis. Main outcome measures. The order of pregnancy and trimester when immunization occurred and treatment of hemolytic disease of the fetus and newborn. Results. A total of 290 RhD immunized women were included in the study. In 147/290 (51%) of the women, sensitization occurred with their first-born child and in 96/290 (33%) it occurred with their second-born child. Anti-D antibodies developed during the second or third trimester in 212/290 (73%) and in 61/290 (21%) at term or after delivery. In subsequent pregnancies 56% (144/259) of the neonates required treatment for hemolytic disease of the fetus and newborn.
Obstetrics & Gynecology Science
ObjectiveTo compare the efficacy and safety of recombinant anti-D (R-anti-D) with conventional polyclonal anti-D (Poly anti-D)in preventing maternal-fetal rhesus D (RhD) alloimmunization and to investigate the immunogenicity of R-anti-D.MethodsThis was a randomized, open-label, multi-center clinical trial conducted in RhD-negative pregnant women who didnot receive antenatal anti-D who delivered RhD-positive babies and showed negative indirect Coombs tests (ICTs)at baseline. The women were randomized in a 2:1 ratio to R-anti-D or Poly anti-D groups and were administered300 mcg (IM) of the corresponding drug within 72 hours of delivery. ICT was performed 72 hours, 90 days, and 180days after anti-D injection. Serum samples were collected to check for the development of antibodies against R-anti-Dat days 90 and 180, using bridging enzyme-linked immunosorbent assay. The proportion of subjects who had positiveICT results at days 90 and 180 were compared between the groups using Fisher’s e...
Should anti-Rh immunoglobulin be given to D variant women?
British Journal of Haematology, 1989
D variant women occasionally form anti-D during or following pregnancy with a D-positive fetus. It is not known whether Rh immunization could be suppressed by using anti-Rh immunoglobulin (Rh Ig), or whether the injected antibodies would be absorbed by the woman's D variant cells. In order to predict the likely outcome, three anti-Rh Ig preparations were absorbed independently with five examples of D variant red cells: RIV'r ( n = 3). RIsr(n= 21, and with cells of common Rh-positive and Rh-negative phenotypes: Ro, r'r, r"r or rr cells (n= 1 each). The titres of the Ig preparations against all these cells were compared after three, six, nine and 12 absorptions.
International Journal of Women's Health, 2010
Transplacental or fetomaternal hemorrhage (FMH) may occur during pregnancy or at delivery and lead to immunization to the D antigen if the mother is Rh-negative and the baby is Rh-positive. This can result in hemolytic disease of the fetus and newborn (HDFN) in subsequent D-positive pregnancies. The aim of this study is to highlight the challenges associated with the effective management and prevention of Rh alloimmunization among Rh-negative women in Sub-Saharan Africa. In most Sub-Saharan African countries, there is poor and sometimes no alloimmunization prevention following potentially sensitizing events and during medical termination of pregnancy in Rh-negative women. Information about previous pregnancies and termination are often lacking in patients' medical notes due to poor data management. These issues have made the management of Rh-negative pregnancy a huge challenge. Despite the fact that the prevalence of Rh-negative phenotype is significantly lower among Africans than Caucasians, Rh alloimmunization remains a major factor responsible for perinatal morbidity in Sub-Saharan Africa and may result in the compromise of the woman's obstetric care due to the unaffordability of anti-D immunoglobulin. There is the urgent need for the implementation of universal access to anti-D immunoglobulin for the Rh-negative pregnant population in Africa. Anti-D immunoglobulin should be available in cases of potentially sensitizing events such as amniocentesis, cordocentesis, antepartum hemorrhage, vaginal bleeding during pregnancy, external cephalic version, abdominal trauma, intrauterine death and stillbirth, in utero therapeutic interventions, miscarriage, and therapeutic termination of pregnancy. There is also the need for the availability of FMH measurements following potentially sensitizing events. The lowcost acid elution method, a modification of the Kleihauer-Betke (KB) test, can become a readily available, affordable, and minimum alternative to flow cytometric measurement of FMH. Knowledge of anti-D prophylaxis among obstetricians, biomedical scientist, midwives, traditional birth attendants, pharmacists, and nurses in Africa needs to be improved. This will facilitate quality antenatal and postnatal care offered to Rh-negative pregnant population and improve perinatal outcomes.
Acta Clinica Belgica, 2009
In Belgium, prevention of anti-D immunization is currently based on systematic postnatal prophylaxis associated with targeted antenatal injection in high-risk situations of foeto-maternal haemorrhage. The failures of prevention are mainly due to the non-respect of established guidelines for RhIG prophylaxis, and to spontaneous undetected foetal-maternal haemorrhages without any obvious cause during the third trimester of pregnancy. In order to reduce the rate of residual post-pregnancy anti-D immunization, several countries decided to associate the classical prophylaxis to a routine antenatal anti-D prophylaxis (RAADP) during the 28th or 29th week of gestation. Since a few years, the foetal RHD genotyping in maternal plasma enables us to limit the antenatal prophylaxis only to those D-women carrying a D+ foetus. This paper deals with: the advantages of an antenatal prevention in the light of non-invasive foetal RHD genotyping, the rules rendering prevention protocols effi cient whatever the algorithm applied, and the recommended immuno-haematology follow-up of women who received RhIG.