A Study to Evaluate Placental Pathologies Using Ultrasound of the Human Placenta
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: 20-000991
NCT ID: NCT04506970
Sponsor Protocol Number: 20-000991
About this study
The purpose of this study is to develop an ultrasound method to identify villitis of unknown etiology (VUE)-induced inflammation in the human placenta during gestation.
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.
Registration – Inclusion Criteria IUGR Cohort:
- Age ≥ 18 and ≤ 45 years at study entry.
- Diagnosis of IUGR before admission to labor and delivery.
- Ability to provide written informed consent.
- Weight greater than 110 pounds (50 kilograms, a standard requirement in obstetrics studies that include blood draws).
- > 28 weeks gestation.
Registration – Inclusion Criteria Control Cohort:
- Age ≥ 18 and ≤ 45 years at study entry.
- No known pregnancy complications at obstetrics visit (+/- 1 week gestational age of IUGR cohort).
- Ability to provide written informed consent.
- Weight greater than 110 pounds (50 kilograms, a standard requirement in obstetrics studies that include blood draws).
- > 28 weeks gestation.
Registration – 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.
- Not planning on delivering at Mayo Clinic.
- Ruptured membranes.
- < 28 weeks gestation.
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 Mauro Schenone, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available