Recurrent Pregnancy Loss
Conditions
Keywords
Recurrent Pregnancy Loss, IVIg, Pregnancy Rate
Brief summary
Miscarriage occurs in about 1-2% of human pregnancies and is one of the common pregnancy problems before 12 weeks of pregnancy. Anatomical and chromosomal abnormalities, microbial factors and auto and alloimmune reactions have been speculated to attribute in recurrent miscarriage. Unexplained recurrent miscarriage (URM) is defined as three or more repeated abortions, probably caused by maternal immunological rejection . Given that maternal immune system encounters semi-allogeneic fetus, pregnancy outcome is associated with the interaction between maternal immune system and immuno-regulatory capability of the fetus. Effectiveness of treatment approaches in RM patients has been controversial and remained to be discovered. Immunomodulatory agents such as corticosteroids and allogeneic lymphocyte immunization showed variable success rates in RM patients. Therapeutic effects of IVIG in unexplained RM is controversial and most positive results were obtained from the trials in RM women with cellular immune abnormalities, such as increased NK cell level and/or cytotoxicity, and T cell abnormalities. Previous studies have shown that the incidence of genetic abnormalities in children who have received immunosuppressive drugs such as IVIg like normal people and normal society. In this study we used IVIg at the time of positive pregnancy,400 mg/kg IVIG was administered intravenously. Following the first administration, IVIG well given every 4 weeks through 32 weeks of gestation to suppress the immune system in patients with immunological causes of RPL and the results will be compared with a control group that did not receive any type of drug.
Interventions
DRUGIVIg
Patients will take 400mg/kg IVIg at the time of positive pregnancy,Following the first administration, IVIG well given every 4 weeks through 32 weeks of gestation.
Sponsors
Tabriz University of Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 41 Years
Healthy volunteers
No
Inclusion criteria
* Enrolled patients will experience at least 3 times recurrent pregnancy loss. * Patients dont have history of any type of immunotherapy. * Patients must have abnormal NK cell or NK cell cytotoxicity or Th1/Th2 ratio
Exclusion criteria
\- Our criteria for exclusion of patients from the study include the following: * Patients or their spouse has abnormal karyotype or chromosomal and genetically disorders. * Patients who have bleeding problems. * Patients who have chronic disorders those are forced to use the specific drug. * Patients who have positive test for HIV, HCV or HBV infection. * Patients who have a history of asthma and allergies. * Patients who have uterus abnormalities.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in NK cells, T reg and Th17 cells frequency. | up to 8 month of pregnancy | Flowcytometry |
| Changes in secretion levels of cytokines related to Treg and Th17 cells(IL-17,IL-21) | up to 8 month of pregnancy | Elisa |
| Changes in exoression of cytokines gene. | up to 8 month of pregnancy | RT pcr |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy rate in patients with Recurrent Pregnancy Loss (RPL) | up to 8 month of pregnancy | by sonography |
| Live berth rate in patients with Recurrent Pregnancy Loss (RPL). | up to 1 year | Monitoring by gynecologists |
Countries
Iran
Outcome results
None listed