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 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT02484820
Eligibility Criteria:
Inclusion Criteria:
* Minimal age of 18 years
* Informed consent
* Confirmation of dating of pregnancy by first trimester echography.
* Episode of threatened preterm labour
* Singleton between 24 and 34 weeks of gestation
* Cervical length ≤20mm in cervimetry
* Pulmonary maturation completed
* ≤6 contractions by hour after 24 hours of tocolysis.
Exclusion Criteria:
* Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
* Spontaneous rupture of membranes at the time of randomization
* Cervical cerclage in situ
* Uterus malformations
* Antecedent of conisation
* Active vaginal bleeding, placenta previa
* Intra-amniotic infection
* Hydramnios
* Maternal chronic pathology (hypertension, diabetes)
* Anomaly of breathing foetal rate
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02484820
Study Brief:
Protocol Section:
NCT02484820