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:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT02576418
Eligibility Criteria:
Inclusion Criteria:
To be eligible for enrollment into this trial, each female subject must fulfill all of the following criteria at the start of enrollment:
* Pregnancies after assisted reproductive technology include singleton and twins
* Between 20 0/7 and 36 6/7 weeks with symptoms of preterm labor including uterine contractions, intermittent lower abdominal pain and pelvic pressure.
* Clinically intact membranes.
* Cervical dilatation of ≤ 2 cm
* Agree to participate in the study, and to disclose any medical events to the investigator
* Have given written informed consent
Exclusion Criteria:
To be eligible for enrollment in this study each subject must not meet any of the following criteria:
* Vaginal bleeding
* Overt rupture of the fetal membranes as indicated by visualized leakage of fluid from the cervix
* Placenta previa
* Cervical cerclage in place
* Received tocolytic medications for treatment of threatened preterm delivery prior to collection of the cervicovaginal specimens or CL measurement.
* Digital exam prior to specimen collection.
* A symptom not associated with idiopathic threatened preterm delivery (e.g trauma)
* Enrollment in a tocolytic study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02576418
Study Brief:
Protocol Section:
NCT02576418