Primary recurrent pregnancy loss with unknown risk factors Habitual Abortions, Recurrent Abortion, Recurrent Miscarriage, Recurrent Early Pregnancy Loss
Conditions
Interventions
Intravenous drip infusion administration of 400 mg/kg of 10% formulation of intact type human immunoglobulin G (Venoglobulin IH, the Japan Blood Products Organization) for five consecutive days. Trea
Immune Globulin, Intravenous
Sponsors
Deguchi Masashi
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Primary recurrent pregnancy loss (RPL) and no children 2) Four or more losses of clinical pregnancy 3-a) no risk factors of abnormal uterine morphology, thyroid dysfunction with abnormal levels of free T4 or TSH, chromosome abnormality in a couple, a positive test of antiphospholipid antibody, or deficiencies of factor XII, protein S, and protein C, and have experienced at least one miscarriage of a fetus with normal chromosome karyotype or 3-b) Experienced at least one miscarriage of a fetus with normal chromosome karyotype after having been treated for risk factors as follows: surgical treatment of septate uterus, medical therapy for thyroid dysfunction, and combination therapy with low dose aspirin and heparin for occasional positive of antiphospholipid antibody test, deficiencies of factor XII, protein S, and protein C 4) Less than 42 years old. 5) Patients who have given their written consent to participate in this study
Exclusion criteria
Exclusion criteria: 1) Chromosome abnormality in a couple, antiphospholipid syndrome defined according to the updated Sydney classification criteria, or the most recent positive test of antiphospholipid antibody 2) No treatment despite having diabetes mellitus or impaired glucose tolerance 3) History of IVIG therapy for RPL 4) History of stillbirth on and after 22 weeks of gestation 5) Treatment for malignancy 6) History of Thromboembolism 7) History of shock or hypersensitivity to immunoglobulin 8) IgA deficiency or serum IgA level less than 5 mg/dL 9) Patients who have received any drug under clinical trial within 12 weeks prior to acquiring consent, or who are currently participating in another clinical trial and receiving medication 10) Patients considered by the investigator to be unsuitable as a subject for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ongoing pregnancy at 22 weeks of gestation of women who received the study drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| Live birth of women who received the study drug Gestational weeks at delivery or pregnancy loss Occurrence of fetal malformations Occurrence of obstetric complications Occurrence of disease | — |
Contacts
Public ContactMasashi Deguchi
Kobe University Hospital
Outcome results
None listed