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 -