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 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT02284867
Eligibility Criteria:
Inclusion Criteria:
1. Maternal age: 18-35 years old (to decrease the incidence of preterm labor related to age factor).
2. Women who present with viable pregnancy (between 28 and 37 weeks' gestation), and having a threatened preterm labor (which is defined as ≥ 2 uterine contractions at 28-37 weeks' gestation, The onset of labor may be determined by documented uterine contractions (at least one every 10 minutes) and ruptured fetal membranes or documented cervical change with an estimated length of less than 1cm or cervical dilation of more than 2 cm. Threatened preterm labor may be diagnosed when there are documented uterine contractions but no evidence of cervical change.
Exclusion Criteria:
1. Multiple pregnancy.
2. Documented uterine anomalies.
3. Oligohydramnios and polyhydramnios .
4. Medical disorders as Diabetes mellitus and hypertension.
5. Preterm premature rupture of membranes.
6. Conditions that may have an influence on immune reaction e.g. history of chorioamnionitis.
7. Smoking as a risk factor for preterm labor.
8. Patients having Autoimmune disorder as it may affect Uterine NK( natural killer ) cells level .
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT02284867
Study Brief:
Protocol Section:
NCT02284867