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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT02441335
Eligibility Criteria:
Cases:
Inclusion Criteria:
* 18-45 years of age
* Singleton pregnancy between 20 0/7 and 36 6/7 weeks gestational age who is admitted with preterm labor or cervical insufficiency (greater than 2 cm dilation) or Preterm Premature Rupture of Membranes
Exclusion Criteria:
* Multiple gestation
* Fetal chromosomal abnormality
* Major fetal anomaly
* Intra-uterine fetal demise
* Gestational hypertension/preeclampsia
Controls:
Inclusion Criteria:
* 18-45 years of age
* Singleton pregnancy that delivers at term (38 to 41 weeks gestational age)
* Admitted to the hospital with spontaneous labor (regular contractions, cervical dilation) or spontaneous rupture of membranes
Exclusion Criteria:
* Multiple gestation
* Fetal chromosomal abnormality
* Major fetal anomaly
* Intra-uterine fetal demise
* Intra-uterine growth restriction
* Gestational hypertension/preeclampsia
* Clinical chorioaminionitis
* Induction of labor
* Elective c-section
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02441335
Study Brief:
Protocol Section:
NCT02441335