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 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT02430233
Eligibility Criteria:
Inclusion Criteria:
1. 18 years of age
2. Tocolytic treatment between 24+0 and 34+0 weeks
3. Patient's consent to participate in this study
4. 24 hours after tocolytic initiation and up to 3 days after finishing the tocolytic treatment
5. Arrest of preterm labor
Exclusion Criteria
1. Contraindication to ongoing pregnancy including:
1. Suspected amnionitis during testing for eligibility- evidence of active infection including temperature ≥ 38.0°C and uterine tenderness, foul-smelling vaginal discharge, maternal tachycardia of 120 beats per minute or greater, or sustained fetal tachycardia of 160 beats per minute or greater
2. Evidence of significant placental abruption (contractions and significant bleeding from placental origin)
3. Intrauterine fetal death diagnosed at the time of admission
2. Major fetal malformation
3. Known maternal allergy to progesterone
4. Current use of progesterone at the time of admission
5. Epilepsy
6. Breast cancer
7. PPROM (preterm premature rupture of membranes) during testing for eligibility
8. Age below 18 years
9. Known active liver disease (elevated liver enzymes at twice the upper normal limit according to medical history or blood test that were taking doring standard medical care)
10. History of deep vein thrombosis
11. Major active psychiatric disorders (major affective disorders and psychotic disorders)
12. Uncontrolled chronic hypertension
13. Heart failure
14. Chronic renal failure
15. Pre-gestational diabetes with known target organ damage
16. History of spontaneous preterm delivery
17. Previous tocolytic treatment during the current pregnancy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02430233
Study Brief:
Protocol Section:
NCT02430233