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 @ 1:12 PM
Ignite Modification Date:
2025-12-24 @ 1:12 PM
NCT ID:
NCT06593795
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 y.o.;
* Pregnant women with a diagnosis of fetal breech presentation eligible and desirous for ECV;
* Singleton;
* At term (≥ 37 weeks);
* Breech presentation;
* No previous uterine scars or other indications for elective C-section;
* Signed written informed consent to study participation.
Exclusion Criteria:
* Age \<18 y.o.;
* Preterm gestational age;
* Multiple pregnancies;
* Indications for elective cesarean section;
* Incomplete obstetrical data;
* Refusal to provide informed consent.
* Desire to an elective C-Section
* Controindications for ECV or vaginal delivery (placental abruption, placenta previa, uterine malformations)
* Reduction of amniotic fluid (AFI \<4 cm)
* Uterine contractions
* Vaginal bleeding
* Premature rupture of membranes
* Nonreassuring fetal heart rate patterns before the procedure.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06593795
Study Brief:
Protocol Section:
NCT06593795