A Study to Identify Microbiome Markers Associated with Preterm Labor
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: 14-002960
Sponsor Protocol Number: 14-002960
About this study
The purpose of this study is to identify components of the vaginal microbiology environment that contribute to the occurance of preterm labor and preterm delivery.
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
- Ability to provide written informed consent
- Willingness to participate in the mandatory translational research component of the study
- Pregnant
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
- Multiple gestations
- Oral or IV antibiotic treatment within the last 4 weeks
- Known uterine anomalies
- Evaluation following trauma event
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Margaret Dow, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available