A Study of the Relationship Between Fetal (Pre-birth Infant) DNA and the Maternal Immune Response

Overview

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.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Elizabeth Ann Enninga, Ph.D.	Closed for enrollment	Contact information: Angela Sivly CCRP (507) 266-1734 Sivly.Angela@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Elizabeth Ann Enninga, Ph.D.

Closed for enrollment

Contact information:

Angela Sivly CCRP

(507) 266-1734

Sivly.Angela@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials