Breech Fetal PresentationREVERSONCT06593795
Ultrasound Parameters for the Outcome Prediction of External Cephalic Version for Fetuses with Breech Presentation
An observational study of Breech Fetal Presentation and Breech Presentation of Fetus with Successful Version, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breech Fetal Presentation, Breech Presentation of Fetus with Successful Version, Vaginal Delivery
- What is being tested?
- ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- Age \<18 y.o.;
- Preterm gestational age;
- Multiple pregnancies;
- Indications for elective cesarean section;
- Incomplete obstetrical data;
- Refusal to provide informed consent.
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- 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.
Trial locations and contacts
No sites are listed yet.
Sascia Moresi, MD contact
About this study
Official title: Prediction of External Cephalic Version Success in Case of Breech Presentation At Term of Pregnancy: a Prospective Observational Study
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.
Read the 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)
- Conditions
- Breech Fetal Presentation, Breech Presentation of Fetus with Successful Version, Vaginal Delivery, Cesarean Section
- Being tested
- ultrasound
- Keywords
- breech, external cephalic version, ultrasound, c-section
- Medical subject headings
- Breech Presentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundProcedure or 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
| Study group | Role | What they receive |
|---|---|---|
| Group ECV | 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 Receives: Procedure: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breech Fetal PresentationStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carducci Brigida, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- silvio tartaglia, MD, Study director, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593795
- Sponsor's protocol ID
- 6366
- Acronym
- REVERSO
- Status last verified
- Feb 2024
- First submitted
- 10 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: this is an internal database
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of External Cephalic Version Success in Case of Breech Presentation At Term of Pregnancy: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06593795
- Acronym / sponsor ID
- REVERSO / 6366
- Conditions
- Breech Fetal Presentation, Breech Presentation of Fetus with Successful Version, Vaginal Delivery, Cesarean Section
- Keywords
- breech, external cephalic version, ultrasound, c-section
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group ECV | – | Procedure: ultrasoundPregnant 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (13 listed)
- Age \<18 y.o.;
- Preterm gestational age;
- Multiple pregnancies;
- Indications for elective cesarean section;
- Incomplete obstetrical data;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundbefore 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 | Procedure or surgery | Group ECV |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. this is an internal database
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sascia Moresi, MD contact
silvio tartaglia, MD study director
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
An observational study of Breech Fetal Presentation and Breech Presentation of Fetus with Successful Version, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvio Tartaglia, MD ((555) 555-1234, silvio.tartaglia@guest.policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate ECV success rate. (time frame: during the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.