Recurrent Pregnancy Loss Neo-self antibody
Conditions
Interventions
None listed
Sponsors
Hirota Yasushi
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1 Women diagnosed with recurrent pregnancy loss, defined as having a history of two or more miscarriages (excluding biochemical pregnancies), who wish to conceive and give birth. 2 Patients who can provide informed consent prior to the initiation of the study. 3 Patients who agree to understand and comply with the planned study procedures. 4 Patients aged 18 years or older at the time of consent.
Exclusion criteria
Exclusion criteria: 1 Patients with causes of recurrent pregnancy loss other than immunological abnormalities, such as uterine malformations or parental chromosomal abnormalities (patients diagnosed with antiphospholipid syndrome are not excluded). 2 Patients deemed inappropriate for inclusion in the study by the principal investigator or co-investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positivity rate of beta-2 glycoprotein I (beta2GPI) neo-self antibodies A value of 73.3 U or higher is defined as positive. The positivity rate will be calculated among those tested for beta2GPI neo-self antibodies. It will also be calculated for the overall cohort as well as stratified by the number of previous miscarriages. Live birth rate and pregnancy continuation rate beyond 22 weeks of gestation Among those who tested positive for beta2GPI neo-self antibodies and achieved an initial clinical pregnancy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Live birth rate and pregnancy continuation rate after 22 weeks of gestation, categorized by medication status at the time of clinical pregnancy, in both beta 2 glycoprotein I neo self antibody positive and negative groups. Live birth rate and pregnancy continuation rate after 22 weeks of gestation, categorized by medication status at the time of clinical pregnancy, according to the number of previous pregnancies and miscarriages (excluding biochemical pregnancies). Live birth rate and pregnancy continuation rate after 22 weeks of gestation, categorized by beta 2 glycoprotein I neo self antibody levels divided into four groups: less than or equal to 59.7 units, 59.7 to 73.3 units, 73.3 to 100 units, and more than or equal to 100 units. Time from beta 2 glycoprotein I neo self antibody testing to the first live birth or delivery after 22 weeks of gestation, within the antibody positive and negative groups. Incidence of thrombotic disorders up to the time of follow-up in beta 2 glycoprotein I neo self antibody positive and negative groups. Relationship between menstrual cycle or gynecological disorders and beta 2 glycoprotein I neo self antibody levels. Relationship between beta 2 glycoprotein I neo self antibody positivity and obstetric complications other than miscarriage, such as hypertensive disorders of pregnancy. Relationship between beta 2 glycoprotein I neo self antibody levels and blood test markers related to vasculitis, antiphospholipid syndrome, or known thrombotic risk factors. | — |
Contacts
Public ContactMari Ichinose
The University of Tokyo
Outcome results
None listed