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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT03497234
Eligibility Criteria:
Inclusion Criteria:
1. Subject is ≥ 18 years of age
2. Subject has singleton gestation
3. Subject has fetus with gestational age ≥ 22 0/7 weeks and ≤ 33 6/7 weeks
4. Subject has had evidence of spontaneous preterm labor as evidenced by documented regular uterine contractions (≥4 per hour) and one or more of the following:
1. Cervical dilation \> 2cm
2. Cervical length of ≤25 mm via transvaginal ultrasound
5. Subject has onset of contractions was within 48 hours of enrollment in the study
6. Subject has documented intact amniotic membranes
7. Subject's care provider plans to perform an amniocentesis procedure -
Exclusion Criteria:
* 1\. Subject has documented ruptured amniotic membranes 2. Subject has a fetus with major fetal or genetic anomaly or chromosomal aneuploidy 3. Subject has maternal or fetal indication for preterm birth (e.g., pre-eclampsia) 4. Subject is unable to provide written informed consent 5. Subject has evidence of non-reassuring fetal heart rate tracing requiring immediate delivery 6. Subject has vaginal bleeding within the past 24 hours 7. Subject has advanced labor (cervix \>4 cm dilated) 8. Subject has HIV, hepatitis 9. Subject has not been enrolled previously in this study and/or is participating in another study (that in the opinion of the Investigator) may interfere with participation in this study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03497234
Study Brief:
Protocol Section:
NCT03497234