An observational study in Breech Fetal Presentation, Breech Presentation of Fetus with Successful Version and Vaginal Delivery, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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.
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 following anonymous data will be recorded:
Before ECV attempt, the following evaluations will be performed:
Fetal transvaginal ultrasound reporting:
Then, all the participants will undergo a transabdominal ultrasound-guided ECV in a semi-sitting position by the same expert operator (B.C.). After the procedure, the following data will be collected:
41 studies on the registry are indexed under Breech Presentation; 10 are open to participants now.
This study's planned enrollment of 120 is below the median of 135 across 10 observational studies indexed under Breech Presentation.
Browse Breech Presentation studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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We will consecutively enroll all pregnant women at the term of gestation with a fetal breech presentation undergoing ECV attempt after counseling at Fondazione Policlinico Universitario Agostino Gemelli IRCCS of Rome, satisfying the inclusion criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pregnant women with a fetus in breech presentation at term of pregnancy undergoing an external cephalic version (ECV) maneuver. This procedure is aimed to induce fetal cephalic position allowing vaginal delivery instead of cesarean section
Procedure: ultrasound
before ECV procedure, an ultrasound will be performed to evaluate * fetal biometry (BPD, HC, AC, FL, EFW); * Occiput position (right, left); * Back position (anterior, posterior, right, left); * Breech variant (footling, frank, complete); * Fetal leg posture (extended, flexed) * Placental localization; * Amniotic Fluid Index (AFI); * Fore-bag of amniotic fluid; * Eventual presence of nuchal cords; * Fetal head ballottement (yes, no); * Occiput-spine angle These parameters will be compared to find predictive factors for successful ECV
To evaluate ECV success rate.
to evaluate clinical and ultrasound parameters possibly predictive of the success of ECV. This will allow the creation of a predictive model for adequate counseling for the women undergoing the procedure for the cephalic version of fetuses in breech presentation at term of pregnancy
Time frame: during the procedure
No study locations are listed for this record.
Plan to share: No — this is an internal database
No publications or documents are linked to this record.
Start is estimated for Oct 2024; primary completion for Oct 2025, 12 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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