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 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT04696003
Eligibility Criteria:
Inclusion Criteria:
* Singleton pregnancy (from 22/0 to 26/0 weeks of gestation)
* Evidence of PPROM from clinical and instrumental investigations
* Oligo/anhydramnion (\< 2 cm deepest amniotic fluid pocket)
Exclusion Criteria:
* fetal death
* placental abnormalities
* labor
* evidence of major structural or chromosomal abnormalities
* signs of chorioamnionitis (maternal fever \> 38° C and one or more of the following criteria: uterine tenderness, malodorous vag-inal discharge, maternal leukocytosis \> 15000 cells/mm3, maternal tachycardia \> 100 beats/min, and fetal heart rate \> 160 bpm).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04696003
Study Brief:
Protocol Section:
NCT04696003