Intravenous immunoglobulin treatment for secondary recurrent miscarriage: a randomised, double-blind, placebo-controlled trial
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Intravenous immunoglobulin treatment for secondary recurrent miscarriage : a randomised, double-blind, placebo-controlled trial. / Christiansen, O B; Larsen, E C; Egerup, P; Lunoee, L; Egestad, L; Nielsen, Henriette Svarre.
I: B J O G, Bind 122, Nr. 4, 03.2015, s. 500-8.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Intravenous immunoglobulin treatment for secondary recurrent miscarriage
T2 - a randomised, double-blind, placebo-controlled trial
AU - Christiansen, O B
AU - Larsen, E C
AU - Egerup, P
AU - Lunoee, L
AU - Egestad, L
AU - Nielsen, Henriette Svarre
N1 - © 2014 Royal College of Obstetricians and Gynaecologists.
PY - 2015/3
Y1 - 2015/3
N2 - 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.
AB - 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.
KW - Abortion, Habitual
KW - Adult
KW - Birth Rate
KW - Birth Weight
KW - Denmark
KW - Double-Blind Method
KW - Female
KW - Gestational Age
KW - Humans
KW - Immunoglobulins, Intravenous
KW - Immunologic Factors
KW - Infant, Newborn
KW - Pregnancy
KW - Treatment Failure
U2 - 10.1111/1471-0528.13192
DO - 10.1111/1471-0528.13192
M3 - Journal article
C2 - 25412569
VL - 122
SP - 500
EP - 508
JO - BJOG: An International Journal of Obstetrics and Gynaecology
JF - BJOG: An International Journal of Obstetrics and Gynaecology
SN - 0140-7686
IS - 4
ER -
ID: 162191024