Ultrasound Parameters for the Outcome Prediction of External Cephalic Version for Fetuses with Br… (NCT06593795) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Ultrasound Parameters for the Outcome Prediction of External Cephalic Version for Fetuses with Breech Presentation
120 participantsStarted 2024-10
Plain-language summary
This study aims to evaluate possible predictors for the successful od external cephalic version (ECV), a procedure that is indicated in your case due to breech presentation of your baby and your desire to avoid cesarean section. Before the procedure, a detailed ultrasound scan will be performed to measure several parameters. After the procedure we will collect data about the duration, outcome and eventual complications of ECV.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.