Breech PresentationECVNCT06816563
Prediction of Version Outcomes for External Maneuvers of Breech Fetus by Assessment of Breech Progression Angle
An observational study of Breech Presentation, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
Trial summary
Breech presentation complicates about 3-4% of single pregnancies at term. Although vaginal delivery is also possible in breech presentations, this is associated with an increased risk of fetal morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Breech Presentation
- How many people
- 200 participants
- Where
- 2 sitesItaly
- Study dates
- 11 Jan 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with a single full-term pregnancy (37-42 gestational weeks) with a fetus in breech presentation
Who may be able to join
- Women >18 years of age with a single pregnancy at term (37-42 gestational weeks) with a fetus in breech presentation
- Acquisition of Informed Consent Form
Who cannot join
- Oligohydramnios: maximum flap < 2cm
- Placenta previa
- Uterine malformations
- Regular uterine dynamics
- Metrorrhagia
- Contraindications to vaginal delivery
Show all 9Show fewer
- Premature rupture of membranes
- Nonreassuring cardiotocographic tracing
- Previous uterine surgery
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Ospedale Maggiore Carlo Alberto Pizzardi
Bologna, Bologna, 40133
Maria Segata, MD
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD, 0512144412, aly.youssef@aosp.bo.it
About this study
Official title: Prediction of Version Outcomes for External Maneuvers of Breech Fetus by Assessment of Breech Progression Angle (breech Progression Angle)
Breech presentation complicates about 3-4% of single pregnancies at term. Although vaginal delivery is also possible in breech presentations, this is associated with an increased risk of fetal morbidity and mortality. The cephalic version for external maneuvers is an obstetric procedure that allows conversion of an abnormal presentation/situation (breech or transverse) to a cephalic presentation by applying pressure to the maternal abdomen. Over the years, many authors have analyzed numerous factors that might be associated with an increased likelihood of successful maneuvering. Over time, transperineal ultrasonography has proven to be a valid, objective, and highly reproducible tool for the assessment of fetal head progression during delivery in conjunction with examination. The Angle of Progression (AoP) is the angle between the line passing through the longitudinal axis of the pubic symphysis and the line passing through the inferior border of the pubic symphysis and tangent to the fetal skull. AoP is an accurate and reproducible parameter for the assessment of fetal head descent during labor, with a strong correlation with the mode of delivery. The investigators are not aware of any studies that have established the role of transperineal ultrasound in assessing podietal engagement and its role in predicting the success of the cephalic version maneuver, an aspect the investigators want to explore with this study.
Read the detailed description
Patients will be recruited before starting the cephalic version for external maneuvers. An ultrasound evaluation will be performed for each patient before the external maneuver version of breech fetus; specifically, the following will be performed:
- Transabdominal ultrasound for evaluation of the following parameters: type of breech presentation, estimated fetal weight (according to Hadlock), maximum amniotic fluid flap, position of the placenta (anterior/posterior or fundic), angle between the fetal spine at the cervical level and the fetal occiput (occipital-spine angle).
- Transperineal ultrasound for evaluation of the following parameters: Breech Progression Angle (BPA), Subpubic Arch (SPA).
If the external maneuver version is successful, an additional transperineal ultrasound will be performed for evaluation of Angle of Progression (AoP).
After delivery, data will be recorded regarding mode of delivery, indication for operative delivery (in case of cesarean section or obstetric suction), neonatal arterial and venous pH, possible admission to the NICU. These data will be collected by consulting the medical records of recruited patients. The population will be recruited as part of the normal care pathway.
- Conditions
- Breech Presentation
- Keywords
- Breech fetus
- Medical subject headings
- Breech Presentation
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of new ultrasound indexes (Breech Progression Angle, BPA)
Evaluation using transperineal ultrasonography, the role of a new ultrasound index (Breech Progression Angle, BPA) in predicting the success of external maneuver version of breech fetus
Measured: During the ultrasound performed before the version for external maneuvers of breech fetus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start11 Jan 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breech PresentationStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816563
- Sponsor's protocol ID
- ECV
- Acronym
- ECV
- Status last verified
- Nov 2024
- First submitted
- 30 Dec 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Version Outcomes for External Maneuvers of Breech Fetus by Assessment of Breech Progression Angle (breech Progression Angle)
- ClinicalTrials.gov ID
- NCT06816563
- Acronym / sponsor ID
- ECV / ECV
- Conditions
- Breech Presentation
- Keywords
- Breech fetus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Feb 2025 (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.
Breech presentation complicates about 3-4% of single pregnancies at term. Although vaginal delivery is also possible in breech presentations, this is associated with an increased risk of fetal morbidity and mortality. The cephalic version for external maneuvers is an obstetric procedure that allows conversion of an abnormal presentation/situation (breech or transverse) to a cephalic presentation by applying pressure to the maternal abdomen. Over the years, many authors have analyzed numerous factors that might be associated with an increased likelihood of successful maneuvering. Over time, transperineal ultrasonography has proven to be a valid, objective, and highly reproducible tool for the assessment of fetal head progression during delivery in conjunction with examination. The Angle of Progression (AoP) is the angle between the line passing through the longitudinal axis of the pubic symphysis and the line passing through the inferior border of the pubic symphysis and tangent to the fetal skull. AoP is an accurate and reproducible parameter for the assessment of fetal head descent during labor, with a strong correlation with the mode of delivery. The investigators are not aware of any studies that have established the role of transperineal ultrasound in assessing podietal engagement and its role in predicting the success of the cephalic version maneuver, an aspect the investigators want to explore with this study.
Detailed description
Patients will be recruited before starting the cephalic version for external maneuvers. An ultrasound evaluation will be performed for each patient before the external maneuver version of breech fetus; specifically, the following will be performed:
- Transabdominal ultrasound for evaluation of the following parameters: type of breech presentation, estimated fetal weight (according to Hadlock), maximum amniotic fluid flap, position of the placenta (anterior/posterior or fundic), angle between the fetal spine at the cervical level and the fetal occiput (occipital-spine angle).
- Transperineal ultrasound for evaluation of the following parameters: Breech Progression Angle (BPA), Subpubic Arch (SPA).
If the external maneuver version is successful, an additional transperineal ultrasound will be performed for evaluation of Angle of Progression (AoP).
After delivery, data will be recorded regarding mode of delivery, indication for operative delivery (in case of cesarean section or obstetric suction), neonatal arterial and venous pH, possible admission to the NICU. These data will be collected by consulting the medical records of recruited patients. The population will be recruited as part of the normal care pathway.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with a single full-term pregnancy (37-42 gestational weeks) with a fetus in breech presentation
Key inclusion criteria (2 listed)
- Women >18 years of age with a single pregnancy at term (37-42 gestational weeks) with a fetus in breech presentation
- Acquisition of Informed Consent Form
Key exclusion criteria (9 listed)
- Oligohydramnios: maximum flap < 2cm
- Placenta previa
- Uterine malformations
- Regular uterine dynamics
- Metrorrhagia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of new ultrasound indexes (Breech Progression Angle, BPA)
Time frame: During the ultrasound performed before the version for external maneuvers of breech fetus
Evaluation using transperineal ultrasonography, the role of a new ultrasound index (Breech Progression Angle, BPA) in predicting the success of external maneuver version of breech fetus
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
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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.
Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breech Presentation, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
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 2 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD (0512144412, aly.youssef@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of new ultrasound indexes (Breech Progression Angle, BPA) (time frame: During the ultrasound performed before the version for external maneuvers of breech fetus). 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 10 Feb 2025.