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

NCT00722475 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2014-11-06

No results posted yet for this study

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.

Conditions

  • Secondary Recurrent Miscarriage

Interventions

DRUG

Intravenous immunoglobulin

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

DRUG

Human albumin

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

Sponsors & Collaborators

  • The Ministry of Science, Technology and Innovation, Denmark

    collaborator OTHER_GOV

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Ole B. Christiansen, MD, D.M.Sc. · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00722475 on ClinicalTrials.gov