Evidence map›Paper›PMID 20634190›Full record

SynthesisHuman reproduction (Oxford, England)2010

Intravenous immunoglobulin and idiopathic secondary recurrent miscarriage: a multicentered randomized placebo-controlled trial.

Mary D Stephenson, William H Kutteh, Susan Purkiss, Cliff Librach, Patricia Schultz, Edwina Houlihan, Chuanhong Liao

Open access · bronzeAbstract readMeta-AnalysisMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Human reproduction (Oxford, England), 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 8 pooled it
3.7field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 8 syntheses or guidelines pooled it, 152 citations in OpenAlex.

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  8. Immunotherapy for recurrent miscarriage.The Cochrane database of systematic reviews · 2014
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  9. Trial
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 2 countries.

Mary D StephensonUniversity 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
William H Kutteh
Susan Purkiss
Cliff Librach
Patricia Schultz
Edwina Houlihan
Chuanhong Liao
University of British Columbia · CAUniversity of Chicago · USUniversity of Tennessee at Knoxville · USUniversity of Toronto · CA

Funding

TRANSLATIONAL RESEARCH UNIVERSITY OF CHICAGO: CLINICAL TRIALSUL1RR024999 · NCRR · UNIVERSITY OF CHICAGO · PI SOLWAY, JULIAN · 2007 to 2011
$25.3M
NCRR NIH HHS 5M01 RR0021141NCRR NIH HHS UL1 RR024999
6 · The paper itself

Abstract

backgroundIdiopathic 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.

methodsWe 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.

resultsA 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).

conclusionsThis 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.

Indexed as

Abortion, HabitualAdultDouble-Blind MethodEarly Termination of Clinical TrialsFemaleHumansImmunoglobulins, IntravenousPregnancyPregnancy OutcomePregnancy RateImmunoglobulins, Intravenous

Identifiers

PMID20634190
PMCPMC2923000
OpenAlexW2144437930

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.