Preeclampsia Clinical Trial
Official title:
The Correlation Between Immunological Reaction of the Seminal Fluid in the Mother's Blood and Pregnancy Complications
It is known that if there isn't an efficient exposure to the paternal antigens before conception, there is an increased risk for the pre-eclampsia (PE) cascade and other pregnancy complications to take place. It is possible that maternal immune system that doesn't develop tolerance to the paternal antigens that the seminal fluid carries, doesn't developed an adequate immune tolerance to the trophoblast cells and due to that, they are being under greater attack during placentation. Thus, the cells don't go through a normal differentiation, don't perform normal pseudo-vasculogenesis and the PE cascade is more likely to be carried out. Both the maternal immune system and the paternal alloantigens have a role in the development of PE. Although the specific etiology remains unclear and can be only hypothesized. In this study the investigators aim is to try and prove that there is a difference in the immunological reactions to semen prior to conception and that these changes are related to PE and/or other obstetric complications. Hence the investigators aim to study the immune response to semen of women that will be exposed to the culprit semen for the first time compare to women that have been exposed to a culprit semen more than once previously (namely more than 1 insemination prior to the time of evaluation). After that, in a prospective cohort study the investigators would follow those women through their pregnancies and check for different pregnancy outcomes. In this manner, the investigators are hoping to create a screening tool that will help to predict pregnancy and fetal complications before conception related to maternal immune responses of paternal antigens.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 1, 2024 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 46 Years |
Eligibility | Inclusion Criteria: - Age 18-45 - 50 women for each group. - Primigravid or first insemination from a new partner/sperm donor (group I) - Women exposed to sperm (from the same donor/partner = 2 times) (Group II) - Singleton gestation - Obtained verbal/written consent to participate in study Exclusion Criteria: - o Multiple gestation - Multifetal gestation - Chronic hypertension - Chronic renal disease - Autoimmune disease (antiphospholipid syndrome, systemic lupus erythematosus) - Vascular disease - Pregestational diabetes mellitus |
Country | Name | City | State |
---|---|---|---|
Israel | Sheba medical center | Ramat Gan | |
Israel | Tel Hashomer Hospital | Ramat Gan |
Lead Sponsor | Collaborator |
---|---|
Sheba Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pregnancy complications | Pregnancy complications including PE, placental abruption, IUGR | 2 years (Anticipated) | |
Secondary | Other pregnancy complications (Clinical or sonographic) | Sonographic indices of placental insufficiency, abortion, Intra uterine fetal death, Oligohidramnion, fetal anomalies, preterm delivery, preterm premature rupture of membranes, mode of delivery and conception success rates. | 2 years (Anticipated) |
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