PMID- 20634190
OWN - NLM
STAT- MEDLINE
DCOM- 20101222
LR  - 20220317
IS  - 1460-2350 (Electronic)
IS  - 0268-1161 (Print)
IS  - 0268-1161 (Linking)
VI  - 25
IP  - 9
DP  - 2010 Sep
TI  - Intravenous immunoglobulin and idiopathic secondary recurrent miscarriage: a 
      multicentered randomized placebo-controlled trial.
PG  - 2203-9
LID - 10.1093/humrep/deq179 [doi]
AB  - BACKGROUND: Idiopathic secondary recurrent miscarriage may be associated with an 
      abnormal maternal immune response to subsequent pregnancies. Intravenous 
      immunoglobulin (IVIG) has been studied in randomized controlled trials (RCTs) 
      with conflicting results. Therefore, a definitive trial was proposed. METHODS: We 
      conducted an investigator-initiated, multicentered, randomized, double-blinded, 
      placebo-controlled trial comparing IVIG with saline in women with idiopathic 
      secondary recurrent miscarriage, defined as a history of at least one prior 
      ongoing pregnancy followed by three or more consecutive unexplained miscarriages. 
      Subjects received either IVIG 500 mg/kg or the equivalent volume of normal 
      saline. Preconception infusions were administered 14-21 days from the projected 
      next menstrual period. With documentation of pregnancy, the subject received the 
      same infusion every 4 weeks until 18-20 weeks of gestation. The primary outcome 
      was an ongoing pregnancy of at least 20 weeks of gestation. RESULTS: A total of 
      82 patients enrolled, of whom 47 had an index pregnancy. All ongoing pregnancies 
      resulted in live births. Therefore, the live birth rates were 70% (16/23) in the 
      IVIG group and 63% (15/24) in the control group (P = 0.760); odds ratio (OR) 1.37 
      [95% confidence interval (CI) 0.41-4.61]. Including only clinical pregnancies 
      (embryo with cardiac activity at 6 weeks of gestation), the live birth rates were 
      equivalent, 94% (16/17) and (15/16), respectively (P > 0.999); OR 1.07 (95% CI 
      0.06-18.62). Meta-analysis of randomized controlled trials (RCTs) evaluating IVIG 
      for idiopathic secondary recurrent miscarriage revealed live birth rates of 70% 
      (31/44) in the IVIG group and 62% (28/45) in the control group (P = 0.503); 
      common OR 1.44 (95% CI 0.59-3.48). CONCLUSIONS: This is the largest RCT to date 
      in which IVIG was evaluated in women with idiopathic secondary recurrent 
      miscarriage; no treatment benefit was found. The meta-analysis, which combined 
      our study results with two prior RCTs, also showed no significant effect of 
      treatment with IVIG.
FAU - Stephenson, Mary D
AU  - Stephenson MD
AD  - University of Chicago Recurrent Pregnancy Loss Program, Department of Obstetrics 
      and Gynecology, University of Chicago, 5841 S. Maryland Avenue (MC 2050), 
      Chicago, IL 60637, USA. mstephen@babies.bsd.uchicago.edu
FAU - Kutteh, William H
AU  - Kutteh WH
FAU - Purkiss, Susan
AU  - Purkiss S
FAU - Librach, Cliff
AU  - Librach C
FAU - Schultz, Patricia
AU  - Schultz P
FAU - Houlihan, Edwina
AU  - Houlihan E
FAU - Liao, Chuanhong
AU  - Liao C
LA  - eng
SI  - ClinicalTrials.gov/NCT00606905
GR  - 5M01 RR0021141/RR/NCRR NIH HHS/United States
GR  - UL1 RR024999/RR/NCRR NIH HHS/United States
PT  - Journal Article
PT  - Meta-Analysis
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20100715
PL  - England
TA  - Hum Reprod
JT  - Human reproduction (Oxford, England)
JID - 8701199
RN  - 0 (Immunoglobulins, Intravenous)
SB  - IM
CIN - Hum Reprod. 2011 Sep;26(9):2586-7; author reply 2587-9. PMID: 21705372
MH  - Abortion, Habitual/immunology/*prevention & control
MH  - Adult
MH  - Double-Blind Method
MH  - Early Termination of Clinical Trials
MH  - Female
MH  - Humans
MH  - Immunoglobulins, Intravenous/*therapeutic use
MH  - Pregnancy
MH  - Pregnancy Outcome
MH  - Pregnancy Rate
PMC - PMC2923000
EDAT- 2010/07/17 06:00
MHDA- 2010/12/24 06:00
PMCR- 2011/09/01
CRDT- 2010/07/17 06:00
PHST- 2010/07/17 06:00 [entrez]
PHST- 2010/07/17 06:00 [pubmed]
PHST- 2010/12/24 06:00 [medline]
PHST- 2011/09/01 00:00 [pmc-release]
AID - deq179 [pii]
AID - 10.1093/humrep/deq179 [doi]
PST - ppublish
SO  - Hum Reprod. 2010 Sep;25(9):2203-9. doi: 10.1093/humrep/deq179. Epub 2010 Jul 15.