Intravenous immunoglobulin treatment for secondary recurrent miscarriage: a randomised, double‐blind, placebo‐controlled trial. (21st November 2014)

• Record Type: Journal Article
• Authors: Christiansen, OB; Larsen, EC; Egerup, P; Lunoee, L; Egestad, L; Nielsen, HS
• Is Part Of: BJOG. Volume 122:Number 4(2015:Apr.)
• Page Start: 500
• Page End: 508
• Publication Date: 2014-11-21
• Subjects: Obstetrics -- Periodicals; Gynecology -- Periodicals; 618
• DOI: 10.1111/1471-0528.13192
• Languages: English
• ISSNs: 1470-0328

Abstract

<abstract abstract-type="main" id="bjo13192-abs-0001"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="bjo13192-sec-0001" sec-type="section"> <title>Objective</title> <p>To determine whether infusions with intravenous immunoglobulin (IVIg) during early pregnancy increase live birth rate in women with secondary recurrent miscarriage compared with placebo.</p> </sec> <sec id="bjo13192-sec-0002" sec-type="section"> <title>Design</title> <p>A single‐centre, randomised, double‐blind, placebo‐controlled trial.</p> </sec> <sec id="bjo13192-sec-0003" sec-type="section"> <title>Setting</title> <p>A tertiary centre for recurrent miscarriage in Copenhagen, Denmark.</p> </sec> <sec id="bjo13192-sec-0004" sec-type="section"> <title>Population</title> <p>A group of 82 women with unexplained secondary recurrent miscarriage and at least four miscarriages.</p> </sec> <sec id="bjo13192-sec-0005" sec-type="section"> <title>Methods</title> <p>Women were randomly assigned to repeated infusions with IVIg or placebo (albumin) from the time of positive pregnancy test to gestational week 15 or pregnancy loss.</p> </sec> <sec id="bjo13192-sec-0006" sec-type="section"> <title>Main outcome measure</title> <p>Primary outcome was birth with neonatal survival in all randomised women.</p> </sec> <sec id="bjo13192-sec-0007" sec-type="section"> <title>Results</title> <p>In the intention‐to‐treat analyses, live birth rates were 23/42 (54.8%) in the IVIg and 20/40 (50.0%) in the placebo group, relative risk 1.11 (95% CI 0.70–1.74). In a per protocol analysis, almost identical results were found. The median gestational length at delivery was higher in the IVIg than the placebo group (282 versus 272 days, <italic>P </italic>=<italic> </italic>0.02) but the mean birthweight was not significantly increased.</p> </sec> <sec id="bjo13192-sec-0008" sec-type="section"> <title>Conclusions</title> <p>In this trial, which is the largest so far, IVIg did not increase the live birth rate in patients with secondary recurrent miscarriage and the treatment cannot be recommended in clinical practice.</p> </sec> </abstract>