Ultrasound Parameters for the Outcome Prediction of External Cephalic Version for Fetuses with Breech Presentation

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 y.o.;

Pregnant women with a diagnosis of fetal breech presentation eligible and desirous for ECV;

Singleton;

At term (≥ 37 weeks);

Disqualifiers

Age <18 y.o.;

Preterm gestational age;

Multiple pregnancies;

Indications for elective cesarean section;

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • ultrasound

    Procedure/Surgery

    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

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Group ECV1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: