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 @ 2:50 PM
Ignite Modification Date:
2025-12-24 @ 2:50 PM
NCT ID:
NCT03033459
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 years or older
2. Female
3. Pregnant
4. At least 27 weeks pregnant
5. Able to read, write, speak, and understand English
6. Has access to a phone (either mobile or landline)
7. Lives within driving distance of Morgantown, WV, or is willing to travel to a location that is within driving distance to Morgantown, WV
Exclusion Criteria:
1. Multiple pregnancy
2. Within one week of due date
3. Has any of the following conditions:
* Developmental or intellectual disability
* Schizophrenia
* Untreated, active tuberculosis
* Human immunodeficiency virus (HIV)/Acquired immunodeficiency syndrome (AIDS)
* Human T-cell lymphotropic virus type I or type II
* History of lumpectomy or radiation to breast
4. Uses or is dependent upon any of the following substances (Moretti, Lee, \& Ito, 2000):
* Heroin
* Cocaine
* Methamphetamines
* Marijuana
* Phencyclidine (PCP)
* Non-prescription opioids (e.g., morphine, oxycodone, hydrocodone)
5. Undergoing any of the following medications/treatments (American Academy of Pediatrics, 2001):
* Antiretrovirals
* Cancer chemotherapy (e.g., antimetabolites)
* Radiation therapy
* Acebutolol
* Atenolol
* Bromocriptine
* Aspirin (salicylates)
* Ergotamine
* Lithium
* Phenobarbital
* Primidone
* Sulfasalazine (salicylazosulfapyridine)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT03033459
Study Brief:
Protocol Section:
NCT03033459