Intravenous immunoglobulin treatment for secondary recurrent miscarriage: A randomised, double-blind, placebo-controlled trial

BJOG: An International Journal of Obstetrics and Gynaecology

Volumn 122, Issue 4, 2015, Pages 500-508

  Christiansen, O B ^a,b   Larsen, E C ^a   Egerup, P ^c   Lunoee, L ^a   Egestad, L ^a   Nielsen, H S ^a  

^a Rigshospitalet   (Denmark)

^b AALBORG UNIVERSITY HOSPITAL   (Denmark)

^c UNIVERSITY OF COPENHAGEN   (Denmark)

Author keywords

Immunotherapy; intravenous immunoglobulin; miscarriage; randomised controlled trial; recurrent miscarriage

Indexed keywords

ALBUMIN; ANTIEMETIC AGENT; ANTIHISTAMINIC AGENT; HUMAN IMMUNOGLOBULIN; IMMUNOGLOBULIN G; PARACETAMOL; PLACEBO; IMMUNOGLOBULIN; IMMUNOLOGIC FACTOR;

ADULT; ARTICLE; BIRTH RATE; BIRTH WEIGHT; CLINICAL ARTICLE; CONTROLLED STUDY; DELIVERY; DENMARK; DOUBLE BLIND PROCEDURE; DRUG COST; DRUG ERUPTION; DRUG INDUCED HEADACHE; DRUG INFUSION; FEMALE; FIRST TRIMESTER PREGNANCY; GESTATIONAL AGE; HUMAN; INTENTION TO TREAT ANALYSIS; INTERVENTION STUDY; LIVE BIRTH; MULTIPLE CYCLE TREATMENT; NAUSEA AND VOMITING; NEWBORN MORTALITY; OUTCOME ASSESSMENT; PARALLEL DESIGN; PREGNANCY TEST; PREGNANT WOMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECURRENT ABORTION; REPEATED DRUG DOSE; RISK FACTOR; SPONTANEOUS ABORTION; TERTIARY HEALTH CARE; ABORTION, HABITUAL; NEWBORN; PREGNANCY; TREATMENT FAILURE;

ABORTION, HABITUAL; ADULT; BIRTH RATE; BIRTH WEIGHT; DENMARK; DOUBLE-BLIND METHOD; FEMALE; GESTATIONAL AGE; HUMANS; IMMUNOGLOBULINS, INTRAVENOUS; IMMUNOLOGIC FACTORS; INFANT, NEWBORN; PREGNANCY; TREATMENT FAILURE;

EID: 84923382642     PISSN: 14700328     EISSN: 14710528     Source Type: Journal    
DOI: 10.1111/1471-0528.13192     Document Type: Article

References (33)

1. Jauniaux E, Farquharson RG, Christiansen OB, Exalto N,. Evidence-based guidelines for the investigation and medical treatment of recurrent miscarriage. Hum Reprod 2006; 21: 2216-22.
2. Shapira E, Ratzon R, Shoham-Vardi I, Serjienko R, Mazor M, Bashiri A,. Primary versus secondary recurrent pregnancy loss-epidemiological characteristics, etiology, and next pregnancy outcome. J Perinat Med 2012; 40: 389-96.
3. Hill JA, Polgar K, Anderson DJ,. T-helper 1-type immunity to trophoblast in women with recurrent spontaneous abortion. JAMA 1995; 273: 1933-6.
4. Quack KC, Vassiliadou N, Pudney J, Anderson DJ, Hill JA,. Leukocyte activation in the decidua of chromosomally normal and abnormal fetuses from women with recurrent abortion. Hum Reprod 2001; 16: 949-55.
5. Kruse C, Rosgaard A, Steffensen R, Varming K, Jensenius JC, Christiansen OB,. Low serum level of mannan-binding lectin is a determinant for pregnancy outcome in women with recurrent spontaneous abortion. Am J Obstet Gynecol 2002; 187: 1313-20.
6. Hiby SE, Regan L, Lo W, Farrell L, Carrington M, Moffett A,. Association of maternal killer-cell immunoglobulin-like receptors and parental HLA-C genotypes with recurrent miscarriage. Hum Reprod 2008; 23: 972-6.
7. King K, Smith S, Chapman M, Sacks G,. Detailed analysis of peripheral blood natural killer (NK) cells in women with recurrent miscarriage. Hum Reprod 2010; 25: 52-8.
8. Thangaratinam S, Tan A, Knox E., Kilby MD, Franklyn J, Coomarasamy A,. Association between thyroid autoantibodies and miscarriage and preterm birth: meta-analysis of evidence. BMJ 2011; 342: d2616.
9. Piosik ZM, Goegebeur Y, Klitkou L, Steffensen R, Christiansen OB,. Plasma TNF-α levels are higher in early pregnancy in patients with secondary compared with primary recurrent miscarriage. Am J Reprod Immunol 2013; 70: 347-58.
10. Kruse C, Steffensen R, Varming K, Christiansen OB,. A study of HLA-DR and -DQ alleles in 588 patients and 562 controls confirms that HLA-DRB1 03 is associated with recurrent miscarriage. Hum Reprod 2004; 19: 1215-21.
11. Nielsen HS, Steffensen R, Varming K, van Halteren AG, Spierings E, Ryder LP, et al. Association of HY-restricting HLA class II alleles with pregnancy outcome in patients with recurrent miscarriage subsequent to a firstborn boy. Hum Mol Genet 2009; 18: 1684-91.
12. Christiansen OB, Kolte AM, Dahl M, Larsen EC, Steffensen R, Nielsen HS, et al. Maternal homozygocity for a 14 base pair insertion in exon 8 of the HLA-G gene and carriage of HLA class II alleles restricting HY immunity predispose to unexplained secondary recurrent miscarriage and low birth weight in children born to these patients. Hum Immunol 2012; 73: 699-705.
13. Nielsen HS, Wu F, Aghai Z, Steffensen R, van Halteren AG, Spierings E, et al. H-Y antibody titers are increased in unexplained secondary recurrent miscarriage patients and associated with low male:female ratio in subsequent live births. Hum Reprod 2010; 25: 2745-52.
14. The German RSA/IVIG Group. Intravenous immunoglobulin in the prevention of recurrent miscarriage. BJOG 1994; 101: 1072-7.
15. Coulam C, Krysa L, Stern J, Bustillo M,. Intravenous immunoglobulin for treatment of recurrent pregnancy loss. Am J Reprod Immunol 1995; 34: 333-7.
16. Christiansen OB, Mathiesen O, Husth M, Rasmussen KL, Ingerslev HJ, Lauritsen JG, et al. Placebo-controlled trial of treatment of unexplained secondary recurrent spontaneous abortions and recurrent late spontaneous abortions with i.v. immunoglobulin. Hum Reprod 1995; 10: 2690-5.
17. Perino A, Vassiliadis A, Vucetich A, Colacurci N, Cignitti M, Semprini AE,. Short-term therapy for recurrent abortion using intravenous immunoglobulins: results of a double-blind placebo-controlled Italian study. Hum Reprod 1997; 12: 2388-92.
18. Stephenson MD, Dreher K, Houlihan E, Wu V,. Prevention of unexplained recurrent spontaneous abortion using intravenous immunoglobulin: a prospective, randomized, double-blinded, placebo-controlled trial. Am J Reprod Immunol 1998; 39: 82-8.
19. Jablonowska B, Selbing A, Palfi M, Ernerudh J, Kjellberg S, Lindton B,. Prevention of recurrent spontaneous abortion by intravenous immunoglobulin: a double-blind placebo-controlled study. Hum Reprod 1999; 14: 838-41.
20. Christiansen OB, Pedersen B, Rosgaard A, Husth M,. A randomized double-blind, placebo-controlled trial of intravenous immunoglobulin in the prevention of recurrent miscarriage: evidence for a therapeutic effect in women with secondary recurrent miscarriage. Hum Reprod 2002; 17: 809-16.
21. Stephenson MD, Kutteh WH, Purkiss S, Librach C, Schultz P, Houlihan E, et al. Intravenous immunoglobulin and idiopathic secondary recurrent miscarriage: a multicentred randomized placebo-controlled trial. Hum Reprod 2010; 25: 2203-9.
22. Schwab I, Nimmerjahn F,. Intravenous immunoglobulin therapy: how does IgG modulate the immune system? Nat Rev Immunol 2013; 13: 176-89.
23. Trinath J, Hegde P, Sharma M, Maddur MS, Rabin M, Vallat JM, et al. Intravenous immunoglobulin expands regulating T cells via induction of cyclogenase-2-dependent prostaglandin E2 in human dendritic cells. Blood 2013; 122: 1419-27.
24. Negi V-S, Elluru S, Siberil S, Graff-Dubois S, Mouthon L, Kazatchkine MD, et al. Intravenous immunoglobulin: an update on the clinical use and mechanisms of action. J Clin Immunol 2007; 27: 233-45.
25. Porter TF, LaCoursiere Y, Scott JR,. Immunotherapy for recurrent miscarriage. Cochrane Database Syst Rev 2006; 2:Art. No. CD000112.
26. Hutton B, Sharma R, Fergusson D, Tinmouth A, Hebert P, Jamieson J, et al. Use of intravenous immunoglobulin for treatment of recurrent miscarriage: a systematic review. BJOG 2007; 114: 134-42.
27. Ata B, Tan SL, Shehata F, Holzer H, Buckett W,. A systematic review of intravenous immunoglobulin for treatment of unexplained recurrent miscarriage. Fertil Steril 2011; 95: 1080-5.
28. Clark DA,. Intravenous immunoglobulin and idiopathic recurrent miscarriage: methodological problems (Letter to the Editor). Hum Reprod 2011; 26: 2586-7.
29. Nielsen HS, Steffensen R, Lund M, Egestad L, Mortensen LH, Andersen AM, et al. Frequency and impact of obstetric complications prior and subsequent to unexplained secondary recurrent miscarriage. Hum Reprod 2010; 25: 1543-52.
30. Seungdamrong A, Purohit M, McCulloh DH, Howland RD, Colon JM, McGovern PG,. Fetal cardiac activity at 4 weeks after in vitro fertilization predicts successful completion of first trimester of pregnancy. Fertil Steril 2008; 90: 1711-5.
31. McQuilten ZK, Wood EM, Savoia H, Cole S,. A review of pathophysiology and current treatment for neonatal alloimmune thrombocytopenia (NAIT) and introducing the Australian NAIT registry. Aust N Z J Obstet Gynaecol 2011; 51: 191-8.
32. Stephenson MD, Awartani KA, Robinson WP,. Cytogenetic analysis of miscarriages from couples with recurrent miscarriage: a case-control study. Hum Reprod 2002; 17: 446-51.
33. Annells MF, Hart PH, Mullighan CG, Heatley SL, Robinson JS, Bardy P, et al. Interleukins-1, -4, -6,-10, tumor necrosis factor, transforming growth factor-beta, FAS and mannose-binding protein C gene polymorphisms in Australian women. Risk of preterm birth. Am J Obstet Gynecol 2004; 191: 2056-67.