Clinical Trial: Trial of the Efficacy of Intravenous Immunoglobulin for Treating Women With Unexplained Secondary Recurrent Miscarriage

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Placebo-controlled, Double-blind Trial of Intravenous Immunoglobulin for Women With Unexplained Secondary Recurrent Miscarriage

Brief Summary: The investigators want to test whether infusions of intravenous immunoglobulin - a blood product known to modify immune responses - in early pregnancy will increase the chance of a subsequent live birth in women with three or more miscarriages after a birth and a total of at least four miscarriages. This will be done in a trial where 82 patients will be randomly allocated to infusions with intravenous immunoglobulin or placebo during pregnancy.

Detailed Summary:
Sponsor: Rigshospitalet, Denmark

Current Primary Outcome: The difference in the subsequent livebirth rate among patients with secondary recurrent miscarriage who, during the trial, receive intravenous immunoglobulin or placebo, respectively, without any exclusions (ITT analysis) [ Time Frame: August 2008 to June 2011 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: The difference in the subsequent livebirth rate among women with secondary recurrent miscarriage who receive intravenous immunoglobulin or placebo, respectively, after relevant and predefined exclusions (PP analysis). [ Time Frame: August 2008 to June 2011 ]

Original Secondary Outcome: Same as current

Information By: Rigshospitalet, Denmark

Dates:
Date Received: July 23, 2008
Date Started: August 2008
Date Completion:
Last Updated: November 5, 2014
Last Verified: November 2014