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 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT02392650
Eligibility Criteria:
Inclusion Criteria:
* Gravidae at risk for preterm birth, defined as: History of prior spontaneous preterm birth at 16w0d-36w6d gestational age confirmed by review of medical records. If efforts to retrieve medical records are unsuccessful, eligibility will depend upon the events surrounding the prior birth and birthweight under 2 kg; Documented shortened cervix \<2.5 cm by transvaginal ultrasound performed by experienced sonographer at \<24 weeks gestational age; Documented and culture-proven complicated lower or upper urinary tract infection defined as a urinary tract infection requiring hospitalization (e.g., pyelonephritis); Documented periodontal disease, treated or untreated; Documented recurrent lower genital infection; Smoking or other chemical dependency that would convey an increased risk of preterm birth; Other clinical concern for high risk of preterm birth (and cleared by PI Dr. Aagaard at BCM or Dr. Saade at UTMB)
* Enrollment at less than or equal to 20 weeks gestation by best obstetrical estimate
* Able to speak English or work with an interpreter
* Cognitively aware enough to be able to participate in the study
* Gravidae with viable pregnancy \>10 weeks gestational age
* Willingness to consent to all required aspects of protocol - There will be additional non-required aspects that we will recruit 20% of subjects to participate in. These will be voluntary opt-in aspects
* 16 years of age or older
Exclusion Criteria:
* Multifetal gestation at any time during the pregnancy
* Known HIV or Hepatitis C infection
* Known immunosuppressive disease
* Use of any of the following drugs within the last 6 months; Cytokines; Methotrexate or immunosuppressive cytotoxic agents
* History of cancer except for squamous or basal cell carcinomas of the skin or thyroid cancer that have been managed and fully treated.
* Major surgery of the GI tract (including gastric bypass), with the exception of cholecystectomy and appendectomy in the past five years. Any major bowel resection at any time. If conditions arise that require such surgeries during participation in the study, subjects will not be excluded after enrollment. If patient develops need for such surgery after enrollment, they will not be excluded.
* Documented chronic GI disorders, (e.g., Crohn's diseae)
* Chronic conditions with GI symptoms, (e.g. cystic fibrosis)
* Autism spectrum disorder or significant developmental delay, psychosis, major depressive disorder, or a history of bipolar disorder if there is concern about ability to consent
* Treatment for or suspicion of ever having had toxic shock syndrome.
* Fatal fetal anomaly. Will exclude after enrollment if not previously identified
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
64 Years
Study:
NCT02392650
Study Brief:
Protocol Section:
NCT02392650