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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT00994058
Eligibility Criteria:
Inclusion Criteria:
1. 24 to 34 weeks pregnant
2. preterm labor
* at least one contraction every 5 minutes for 30 minutes
* \> 3 cm cervical dilation; \> 80% cervical effacement
3. Have received tocolysis therapy
4. Anticipate a normal spontaneous vaginal delivery (NSVD)
5. Be at least 18 years of age
6. Have signed a written informed consent document
7. Be willing and able to comply with study requirements
Exclusion Criteria:
1. Severe preeclampsia
2. Severe abruption placenta
3. Rupture of amnionic membranes
4. Frank chorioamnionitis
5. Fetal death
6. Fetal anomaly incompatible with life
7. Severe fetal growth restriction (estimated fetal weight \<5%)
8. Mature fetal lung studies
9. Maternal cardiac arrythmias
10. A permanent cardiac pacemaker
11. A fetal cardiac arrhythmia
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00994058
Study Brief:
Protocol Section:
NCT00994058