Maternal and fetal safety of intravenous immunoglobulin in women with reproductive failure.
intravenous immunoglobulin G
obstetric complication
pregnancy
teratogenicity
Journal
American journal of reproductive immunology (New York, N.Y. : 1989)
ISSN: 1600-0897
Titre abrégé: Am J Reprod Immunol
Pays: Denmark
ID NLM: 8912860
Informations de publication
Date de publication:
12 2021
12 2021
Historique:
revised:
04
06
2021
received:
21
01
2021
accepted:
04
08
2021
pubmed:
8
8
2021
medline:
29
3
2022
entrez:
7
8
2021
Statut:
ppublish
Résumé
Intravenous immunoglobulin G (IVIG) is an emerging regimen for women with reproductive failures (RF) during- or pre-pregnancy who have aberrant cellular immune reactions. Studies investigating teratogenicity of IVIG have been limited. Herein, we evaluated the fetal teratogenicity of IVIG and IVIG-related obstetric complications. Women who used IVIG during pregnancy due to RF with cellular immune aberrances were enrolled from four medical centers in Korea. The pregnancy outcomes were collected. A total of 370 RF women who used IVIG during their pregnancy were enrolled. Most of the patients started the IVIG therapy before 12 weeks of gestation and 229 women continued IVIG treatment beyond 12 weeks of gestation. The mean age of the subjects was 34.8 years and the mean total dosage of IVIG was 125.3 g. A total of 307 women had livebirths and six of them were twins. Of 301 singleton livebirths, obstetric complications were developed as follows: preterm births (12.0%), gestational diabetes (7.0%), preeclampsia (4.0%), placental abruption (1.3%), placenta previa (4.3%), and placenta accrete (1.7%). Total six cases (1.99%) had major fetal anomalies in livebirths. The incidence of birth defects is similar to those of the general population in Korea and the previous report in infertile women. No IVIG -related viral contamination was noted. IVIG use during pregnancy did not increase obstetric complications and fetal teratogenicity. This study can be an evidence of maternal and fetal safety of IVIG administration during pregnancy.
Substances chimiques
Immunoglobulins, Intravenous
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e13492Informations de copyright
© 2021 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Références
Mascarenhas MN, Flaxman SR, Boerma T, Vanderpoel S, Stevens GA. National, regional, and global trends in infertility prevalence since 1990: a systematic analysis of 277 health surveys. PLoS Med. 2012;9(12):e1001356.
Zinaman MJ, Clegg ED, Brown CC, O'Connor J, Selevan SG. Estimates of human fertility and pregnancy loss. Fertil Steril. 1996;65(3):503-509.
Collaborators GBDCM. Global, regional, national, and selected subnational levels of stillbirths, neonatal, infant, and under-5 mortality, 1980-2015: a systematic analysis for the global burden of disease study 2015. Lancet. 2016;388(10053):1725-1774.
Organization WH. Preterm birth. . Nov 2016; http://www.who.int/mediacentre/factsheets/fs363/en/
Chaigne B, Mouthon L. Mechanisms of action of intravenous immunoglobulin. Transfus Apher Sci. 2017;56(1):45-49.
Schiff RI. Transmission of viral infections through intravenous immune globulin. N Engl J Med. 1994;331(24):1649-1650.
CoDCaP (CDC. Epidemiologic notes and reports outbreak of hepatitis c associated with intravenous immunoglobulin administration - united states, october 1993-June 1994. MMWR Morb Mortal Wkly Rep. 1994;43:505-509.
Razvi S, Schneider L, Jonas MM, Cunningham-Rundles C. Outcome of intravenous immunoglobulin-transmitted hepatitis C virus infection in primary immunodeficiency. Clin Immunol. 2001;101(3):284-288.
Thornton CA, Ballow M. Safety of intravenous immunoglobulin. Arch Neurol. 1993;50(2):135-136.
Kinney J, Mundorf L, Gleason C, et al. Efficacy and pharmacokinetics of intravenous immune globulin administration to high-risk neonates. Am J Dis Child. 1991;145(11):1233-1238.
Ohlsson A, Lacy J. Intravenous immunoglobulin for suspected or subsequently proven infection in neonates. Cochrane Database Syst Rev. 2010(3):CD001239.
Services USDoHH. FDA Pregnancy Categories. 2019; https://chemm.nlm.nih.gov/pregnancycategories.htm. Accessed October 1, 2019.
Agency EM. Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration. In: 2018.
Bashiri A, Halper KI, Orvieto R. Recurrent implantation failure-update overview on etiology, diagnosis, treatment and future directions. Reprod Biol Endocrinol. 2018;16(1):121.
EGGo RPL, Bender Atik R, Christiansen OB, et al. ESHRE guideline: recurrent pregnancy loss. Hum Reprod Open. 2018;2018(2):hoy004.
Lee SK, Kim JY, Han AR, et al. Intravenous immunoglobulin g improves pregnancy outcome in women with recurrent pregnancy losses with cellular immune abnormalities. Am J Reprod Immunol. 2016;75(1):59-68.
Lee S, Kim J, Jang B, et al. Fluctuation of peripheral blood T, B, and NK cells during a menstrual cycle of normal healthy women. J Immunol. 2010;185(1):756-762.
Simister NE. Placental transport of immunoglobulin G. Vaccine. 2003;21(24):3365-3369.
Levi Setti PE, Moioli M, Smeraldi A, et al. Obstetric outcome and incidence of congenital anomalies in 2351 IVF/ICSI babies. J Assist Reprod Genet. 2016;33(6):711-717.
Materna-Kiryluk A, Wieckowska B, Wisniewska K, et al. Maternal reproductive history and the risk of isolated congenital malformations. Paediatr Perinat Epidemiol. 2011;25(2):135-143.
Palmeira P, Quinello C, Silveira-Lessa AL, Zago CA, Carneiro-Sampaio M. IgG placental transfer in healthy and pathological pregnancies. Clin Dev Immunol. 2012;2012:985646.
Boschetti N, Stucki M, Spath PJ, Kempf C. Virus safety of intravenous immunoglobulin: future challenges. Clin Rev Allergy Immunol. 2005;29(3):333-344.
Giorgio E, De Oronzo MA, Iozza I, et al. Parvovirus B19 during pregnancy: a review. J Prenat Med. 2010;4(4):63-66.
Zuercher AW, Spirig R, Baz Morelli A, Rowe T, Kasermann F. Next-generation Fc receptor-targeting biologics for autoimmune diseases. Autoimmun Rev. 2019;18(10):102366.
Romero R, Gotsch F, Pineles B, Kusanovic JP. Inflammation in pregnancy: its roles in reproductive physiology, obstetrical complications, and fetal injury. Nutr Rev. 2007;65(12 Pt 2):S194-202.
Jivraj S, Anstie B, Cheong YC, Fairlie FM, Laird SM, Li TC. Obstetric and neonatal outcome in women with a history of recurrent miscarriage: a cohort study. Hum Reprod. 2001;16(1):102-106.
Sheiner E, Levy A, Katz M, Mazor M. Pregnancy outcome following recurrent spontaneous abortions. Eur J Obstet Gynecol Reprod Biol. 2005;118(1):61-65.
Pandian Z, Bhattacharya S, Templeton A. Review of unexplained infertility and obstetric outcome: a 10 year review. Human reproduction (Oxford, England). 2001;16(12):2593-2597.
Chin TH, Hsu YC, Soong YK, et al. Obstetric and perinatal outcomes of pregnancy in patients with repeated implantation failure. Taiwan J Obstet Gynecol. 2019;58(4):487-491.
Han AR, Ahn H, Vu P, et al. Obstetrical outcome of anti-inflammatory and anticoagulation therapy in women with recurrent pregnancy loss or unexplained infertility. Am J Reprod Immunol. 2012;68(5):418-427.
Korea S, Final Results of Birth Statistics in 2014. In: 2015.
Ryu HM. Prevalence and risk factors of pregnancy complications. Cheil General Hospital & Women's Healthcare Center; 2014:11-1352173-000082-01.
Field K, Murphy DJ. Perinatal outcomes in a subsequent pregnancy among women who have experienced recurrent miscarriage: a retrospective cohort study. Hum Reprod. 2015;30(5):1239-1245.
Oliver-Williams C, Fleming M, Wood AM, Smith G. Previous miscarriage and the subsequent risk of preterm birth in Scotland, 1980-2008: a historical cohort study. BJOG. 2015;122(11):1525-1534.
Basso O, Baird DD. Infertility and preterm delivery, birthweight, and caesarean section: a study within the danish national birth cohort. Human reproduction (Oxford, England). 2003;18(11):2478-2484.
Luke B, Gopal D, Cabral H, Stern JE, Diop H. Pregnancy, birth, and infant outcomes by maternal fertility status: the massachusetts outcomes study of assisted reproductive technology. Am J Obstet Gynecol. 2017;217(3):327 e321-327 e314.
Pandey S, Shetty A, Hamilton M, Bhattacharya S, Maheshwari A. Obstetric and perinatal outcomes in singleton pregnancies resulting from IVF/ICSI: a systematic review and meta-analysis. Human Reproduction Update. 2012;18(5):485-503.
Chen KH, Chen IC, Yang YC, Chen KT. The trends and associated factors of preterm deliveries from 2001 to 2011 in taiwan. Medicine (Baltimore). 2019;98(13):e15060.
Trogstad L, Magnus P, Moffett A, Stoltenberg C. The effect of recurrent miscarriage and infertility on the risk of pre-eclampsia. BJOG. 2009;116(1):108-113.
Sugiura M. Genetic factors as a cause of recurrent miscarriage. Acta Obst Gynaec Jpn. 2011;63:10.