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 @ 7:16 PM
Ignite Modification Date:
2025-12-24 @ 7:16 PM
NCT ID:
NCT00536003
Eligibility Criteria:
Inclusion Criteria:
* Gestational age between 240/7 et 336/7 weeks of gestation (based on a reliable estimate by ultrasound performed before 22 weeks)
* Singleton pregnancy
* Intact membranes
* Preterm labor defined as:
* 2 or more regular and painful uterine contractions in 10 minutes plus one or plus of the following criteria:
* short cervix detected by vaginal ultrasound scanning (cervical length less than 30 mm until 31 weeks and less than 25 mm from 32 weeks)
* cervical changes detected clinically (cervical length less or equal 10 mm or Bishop score less than 6
* cervical changes during hospitalization (more or equal 5 mm between two clinical or US exams)
* positive fetal fibronectin
* Age ≥ 18 years old
* Signed informed consent
* Possible and accepted follow-up
Exclusion Criteria:
* Multiple gestation
* Cervical cerclage
* Hydramnios (AFI \>95th percentile for gestational age or greatest pocket \>8 cm)
* Premature rupture of membranes
* Chorioamnionitis (criteria for clinical diagnosis are: elevated WBC, elevated CRP, maternal tachycardia, fetal tachycardia, uterine tenderness and/or amniotic fluid foul odor)
* Cervical dilatation \> 3 cm
* Placenta praevia or abruptio placentae
* Intra-uterine growth restriction or non-reassuring fetal status
* Pre-eclampsia or severe hypertension
* Any other maternal or fetal pathology which should indicate medically preterm delivery
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00536003
Study Brief:
Protocol Section:
NCT00536003