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

Prediction of External Cephalic Version Success in Case of Breech Presentation At Term of Pregnancy: a Prospective Observational Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06593795
Acronym
REVERSO
Enrollment
120
Registered
2024-09-19
Start date
2024-10-31
Completion date
2026-10-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breech Fetal Presentation, Breech Presentation of Fetus with Successful Version, Cesarean Section, Vaginal Delivery

Keywords

breech, external cephalic version, ultrasound, c-section

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 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.

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 following anonymous data will be recorded: * Demographic and anthropometric data (i.e., age (y), ethnicity, height (m), weight (kg), BMI); * Parity * Gestational Age (weeks + days) Before ECV attempt, the following evaluations will be performed: * Vaginal examination to evaluate the cervical dilatation and the level of presenting part (floating or not floating) * Fetal transvaginal ultrasound reporting: * 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 (see Figure 1) 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: * Success (yes, no) * Duration of the procedure (min); * Direction of fetal flip in case of success (frontside flip, backside flip) * Pain perception in Numerical Rating Scale (NRS) (1-10); * Reason for terminating the procedure (success, failure, pain, uterine contractions, non-reassuring fetal conditions)

Interventions

PROCEDUREultrasound

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

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
To evaluate ECV success rate.during the procedureto 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

Contacts

Primary ContactSilvio Tartaglia, MD
silvio.tartaglia@guest.policlinicogemelli.it(555) 555-1234
Backup ContactSascia Moresi, MD
sascia.moresi@policlinicogemelli.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026