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NCT Number: NCT06593795

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

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.

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Key information

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound

Procedure

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

Primary outcomes

  1. To evaluate ECV success rate.

    Time frame: during the procedure

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Sascia Moresi, MD

CONTACT

[email protected]

Silvio Tartaglia, MD

CONTACT

[email protected]

(555) 555-1234

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: REVERSO

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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