Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT04638257
Eligibility Criteria:
Inclusion Criteria:
1. Pregnant women \<18 weeks gestational age
2. \>18 years old and able provide informed consent
3. No clinical bacterial vaginosis requiring anti-microbial treatment
4. BV Blue test positive on screening
5. Planned or probable delivery at UTMB, Galveston
Exclusion Criteria:
1. Taking antibiotics or any other microbial at the time of recruitment
2. Documented need for cervical cerclage
3. Multi fetal pregnancy
4. Known aneuploidy or lethal fetal anomalies
5. Illicit drug use
6. Serious maternal medical conditions
1. Renal insufficiency with serum creatinine \>1.5, known proteinuria \>300mg/24 hours or receiving dialysis.
2. Chronic liver disease with liver transaminases \>2 times the upper limit of the normal range
3. Organ transplant recipients.
4. Severe pulmonary disorder (such as significant obstructive/restrictive disorder, pulmonary hypertension, cystic fibrosis, and chronic oxygen requirement).
5. Severe heart disease (such as cardiomyopathy with decreased left ventricular ejection fraction, obstructive valvular disease, replaced heart valve, uncorrected aortic coarctation or tetrology).
6. Established lupus anticoagulant syndrome or antiphospholipid syndrome).
7. Diabetes class C and greater
8. Chronic conditions requiring medications for control (such as chronic hypertension, SLE, inflammatory bowel disease, and asthma).
9. Acquired Immunodeficiency Syndrome or HIV infection without AIDS.
7. Medical complications of pregnancy
1. Pre-eclampsia
2. Thrombophilia
3. Pregnancy induced hypertension
4. Gestational diabetes
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT04638257
Study Brief:
Protocol Section:
NCT04638257