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Search / Trial NCT06593795

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

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Sep 10, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Breech External Cephalic Version Ultrasound C Section

ClinConnect Summary

This clinical trial is studying a procedure called external cephalic version (ECV), which is used to turn babies that are positioned feet-first (breech) into a head-down position before delivery. The goal is to see if certain ultrasound measurements taken before the procedure can help predict whether ECV will be successful. This is important for pregnant women who want to avoid a cesarean section and have a vaginal delivery. Participants will undergo a detailed ultrasound scan, and afterwards, researchers will gather information about how long the procedure took, its outcomes, and any complications that may arise.

To be eligible for this trial, women must be at least 18 years old, pregnant with a single baby that is breech and at least 37 weeks along, and they should be interested in the ECV procedure. They should not have any prior uterine surgeries or conditions that would require a cesarean section. If they decide to participate, they will need to provide written consent. It's important to note that the trial is not yet recruiting participants, so women interested in this study will need to wait until it begins.

Gender

FEMALE

Eligibility criteria

  • 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.

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Patients applied

0 patients applied

Trial Officials

silvio tartaglia, MD

Study Director

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported