A Study of the Relationship Between Fetal (Pre-birth Infant) DNA and the Maternal Immune Response
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 13-008482
Sponsor Protocol Number: 13-008482
About this study
The purpose of this study is to learn the relationship between fetal (pre-birth infant) DNA and the mother's immune system. Fetal DNA can be found in the Mother's blood as early as 4 weeks after conception. The study wants to know if high levels of fetal DNA cause a maternal immune response that leads to problems like preterm birth.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Age ≥18 and ≤35 years at study entry
- Healthy women
- First pregnancy (to eliminate any potential confusion related to alterations in immunity that may remain from previous pregnancies)
- No known pregnancy complications at the first obstetrics visit (uncomplicated pregnancy)
- Ability to provide written informed consent.
- Weight greater than 110 pounds (50 kilograms, a standard requirement in obstetrics studies that include blood draws).
Exclusion Criteria
- Known immunodeficiency.
- Chronic, active viral infections, including HIV-1/2, HTLV-1/2, hepatitis B/C.
- Known autoimmune disease (e.g., rheumatoid arthritis or systemic lupus erythematosus).
- Solid organ or transplant recipient.
- Prior pregnancy termination or known miscarriage.
- Current smokers (tobacco exposure within 30 days of registration).
- Conceptions from assisted reproductive technology. Prior Clomid® use is allowed.
- Multiple gestations.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available