Status:
NOT_YET_RECRUITING
Ultrasound Parameters for the Outcome Prediction of External Cephalic Version for Fetuses with Breech Presentation
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Breech Fetal Presentation
Breech Presentation of Fetus with Successful Version
Eligibility:
FEMALE
18+ years
Brief 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 desir...
Detailed Description
Pregnant women with a diagnosis of fetal breech presentation, desirous of an attempt of ECV after counseling and written consent and hospitalized for the procedure will be consecutively enrolled. The ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06593795
Start Date
October 1 2024
End Date
October 1 2026
Last Update
September 19 2024
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