CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 82 enrolled
Drug / intervention
Intravenous immunoglobulin +1 moredrug
Likely dose
Intravenous immunoglobulin 35 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00722475
NCT00722475Phase 3Completed

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

Rigshospitalet, Denmark·interventional·Posted Jul 25, 2008·Updated Nov 6, 2014

In Brief

A Phase 3 clinical trial evaluating Intravenous immunoglobulin and Human albumin for Secondary Recurrent Miscarriage. Completed, enrolled 82 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark

Timeline

Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 25, 2008
Enrollment StartAug 1, 2008
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 17.9 years ago

Interventions

Intravenous immunoglobulindrug

Intravenous infusions, 25-35 g each time, 4th to 15th gestational week

Human albumindrug

Repeated infusions of Human Albumin 5%, 250-350 ml between 4th and 15th gestational week