Antenatal intravenous immunoglobulins in pregnancies at risk of fetal and neonatal alloimmune thrombocytopenia: comparison of neonatal outcome in treated and nontreated pregnancies - 23/08/22
Abstract |
Background |
Maternal alloantibodies to human platelet antigen-1a can cause severe intracranial hemorrhage in a fetus or newborn. Although never evaluated in placebo-controlled clinical trials, most Western countries use off-label weekly administration of high-dosage intravenous immunoglobulin in all pregnant women with an obstetrical history of fetal and neonatal alloimmune thrombocytopenia. In Norway, antenatal intravenous immunoglobulin is only recommended in pregnancies wherein a previous child had intracranial hemorrhage (high-risk) and is generally not given in other human platelet antigen-1a alloimmunized pregnancies (low-risk).
Objective |
To compare the frequency of anti-human platelet antigen-1a-induced intracranial hemorrhage in pregnancies at risk treated with intravenous immunoglobulin vs pregnancies not receiving this treatment as a part of a different management program.
Study Design |
This was a retrospective comparative study where the neonatal outcomes of 71 untreated human platelet antigen-1a-alloimmunized pregnancies in Norway during a 20-year period was compared with 403 intravenous-immunoglobulin-treated pregnancies identified through a recent systematic review. We stratified analyses on the basis of whether the mothers belonged to high- or low-risk pregnancies. Therefore, only women who previously had a child with fetal and neonatal alloimmune thrombocytopenia were included.
Results |
Two neonates with brain bleeds were identified from 313 treated low-risk pregnancies (0.6%; 95% confidence interval, 0.2–2.3). There were no neonates born with intracranial hemorrhage of 64 nontreated, low-risk mothers (0.0%; 95% confidence interval, 0.0–5.7). Thus, no significant difference was observed in the neonatal outcome between immunoglobulin-treated and untreated low-risk pregnancies. Among high-risk mothers, 5 of 90 neonates from treated pregnancies were diagnosed with intracranial hemorrhage (5.6%; 95% confidence interval, 2.4–12.4) compared with 2 of 7 neonates from nontreated pregnancies (29%; 95% confidence interval, 8.2–64.1; P=.08).
Conclusion |
The most reliable data hitherto for the evaluation of intravenous immunoglobulins treatment in low-risk pregnancies is shown herein. We did not find evidence that omitting antenatal intravenous immunoglobulin treatment in low-risk pregnancies increases the risk of neonatal intracranial hemorrhage.
Le texte complet de cet article est disponible en PDF.Key words : alloimmunization, antenatal management, human platelet antigen 1a, intracranial hemorrhage, intravenous immunoglobulins, neonatal alloimmune thrombocytopenia, newborn
Plan
| J.K.K. and H.T. share senior authorship. |
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| J.K.K. belongs to a group of founders and owners of Prophylix AS—a Norwegian biotech company that has produced a hyperimmune antihuman platelet antigen (HPA)-1a immunoglobulin G (IgG) (NAITgam) for the prevention of HPA-1a-alloimmunization and fetal and neonatal alloimmune thrombocytopenia (FNAIT). J.K.K. is also a consultant for Rallybio IPA, LLC—a US biotech company that will continue the development of NAITgam until licensure. H.T. reports previous payment from Prophylix AS related to a patent on a monoclonal anti-HPA-1a antibody and is funded as a research consultant by Janssen since August 2021. H.T. will also be a local study site principal investigator in a planned multicenter natural history study on FNAIT sponsored by Rallybio. The other authors report no conflict of interest. |
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| This study received no external funding. No entity other than the authors listed played any role in the design of the study; the collection, analysis, or interpretation of data; writing of the report; or the decision to submit the paper for publication. |
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| Cite this article as: Ernstsen SL, Ahlen MT, Johansen T, et al. Antenatal intravenous immunoglobulins in pregnancies at risk of fetal and neonatal alloimmune thrombocytopenia: comparison of neonatal outcome in treated and nontreated pregnancies. Am J Obstet Gynecol 2022;227:506.e1-12. |
Vol 227 - N° 3
P. 506.e1-506.e12 - septembre 2022 Retour au numéro
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