Secondary Recurrent Miscarriage
Conditions
Keywords
recurrent miscarriage, immunology, intravenous immunoglobulin, 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.
Interventions
DRUGIntravenous immunoglobulin
Intravenous infusions, 25-35 g each time, 4th to 15th gestational week
DRUGHuman albumin
Repeated infusions of Human Albumin 5%, 250-350 ml between 4th and 15th gestational week
Sponsors
The Ministry of Science, Technology and Innovation, Denmark
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* 4 or more miscarriages before the end of gestational week 14 in patients with secondary recurrent miscarriages. * At least three of these must be consecutive after the previous birth * At least two of the miscarriages with the present partner.
Exclusion criteria
* Age below 18 or above 41 years at conception * Significant uterine anomalies detected by hysterosalpingography, hysteroscopy or hydrosonography. * Significant chromosomal aberrations in the couple * Menstrual cycle \< 23 or \> 35 days * Presence of lupus anticoagulant or IgG anticardiolipin concentration \>= 40 GPL ku/l or plasma homocystein \>= 25 microg./l by repeated measurements at 8 weeks intervals * Tests positive for HIV or tests indicating carriage of hepatitis B or C * IgA deficiency * Allergy to albumin, IvIg or one of the substances added to preserve the drugs. * Presence of chronic disease, which necessitate permanent treatment with e.g. corticosteroids , non-steroidal antiinflammatory drugs, anticoagulation, simvastatin or imurel from the start of pregnancy. * Less than 2 of the previous pregnancy losses documented by ultrasound or uterine curettage. * Present pregnancy a result of donor insemination or egg donation. * Planned administration of gestagens or estrogens from the beginning of pregnancy. * 3 or more previous IVF/ICSI/FER attempts resulting in chemical pregnancy/miscarriage. * Previous participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | August 2008 to June 2011 |
Secondary
| Measure | Time frame |
|---|---|
| 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). | August 2008 to June 2011 |
Countries
Denmark
Outcome results
None listed