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 @ 1:05 PM
Ignite Modification Date:
2025-12-24 @ 1:05 PM
NCT ID:
NCT04538261
Eligibility Criteria:
Inclusion Criteria:
1. Women delivering at AdventHealth Orlando campus.
2. Breech presenting part as diagnosed by bedside sonography.
3. No prior deliveries \>/= 20 weeks gestational age.
4. Pregnancy is between 37-40 weeks gestational age.
5. Live fetus.
6. Patient is \>/= age 18.
7. Patient speaks English or Spanish as primary language.
8. Patient able to understand verbal and written consent
Exclusion Criteria:
1. Non-breech presentation (cephalic, transverse, oblique).
2. More than 1 fetus.
3. Cervical dilation of \>/= 1cm.
4. Prior uterine incision.
5. Congenital uterine anomaly.
6. Body mass index more than 40 kg/m2.
7. Uterine fibroids causing soft tissue dystocia.
8. Extended fetal neck.
9. Oligohydramnios (4-quadrant amniotic fluid index \</= 5cm).
10. Spontaneous rupture of membranes.
11. Any contraindication to vaginal delivery.
12. Intrauterine growth restriction (estimated fetal weight \</= 10%ile).
13. Estimated fetal weight \> /= 5,000 grams for non-diabetic patient or \>/= 4,500 grams for patient with pre-existing or gestational diabetes, confirmed by ultrasound.
14. Fetal gastroschisis.
15. Fetal neural tube defect.
16. Severe-range preeclampsia.
17. Patient had regional anesthesia immediately prior to ECV.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04538261
Study Brief:
Protocol Section:
NCT04538261