Intravenous immunoglobulin treatment for secondary recurrent miscarriage: a
randomised, double-blind, placebo-controlled trial.
Author(s): Christiansen OB(1), Larsen EC, Egerup P, Lunoee L, Egestad L, Nielsen HS.
Affiliation(s): Author information:
(1)Fertility Clinic 4071, Rigshospitalet, Copenhagen University Hospital,
Copenhagen, Denmark; Department of Obstetrics and Gynaecology, Aalborg University
Hospital, Aalborg, Denmark.
Publication date & source: 2015, BJOG. , 122(4):500-8
OBJECTIVE: To determine whether infusions with intravenous immunoglobulin (IVIg)
during early pregnancy increase live birth rate in women with secondary recurrent
miscarriage compared with placebo.
DESIGN: A single-centre, randomised, double-blind, placebo-controlled trial.
SETTING: A tertiary centre for recurrent miscarriage in Copenhagen, Denmark.
POPULATION: A group of 82 women with unexplained secondary recurrent miscarriage
and at least four miscarriages.
METHODS: 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.
MAIN OUTCOME MEASURE: Primary outcome was birth with neonatal survival in all
randomised women.
RESULTS: 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, P = 0.02) but the mean birthweight was not
significantly increased.
CONCLUSIONS: 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.
|