Assessing factors for successful external maneuvers in breech pregnancies
Prediction of Version Outcomes for External Maneuvers of Breech Fetus by Assessment of Breech Progression Angle (breech Progression Angle)
This study is trying to see if certain ultrasound measurements can help predict how successful a technique is at turning breech babies into the right position for delivery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 2 sites (Bologna, Bologna and 1 other locations) |
| Trial ID | NCT06816563 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of external cephalic version maneuvers in breech pregnancies by analyzing various ultrasound parameters. Patients will undergo transabdominal and transperineal ultrasound assessments to measure factors such as breech presentation type, estimated fetal weight, and the Breech Progression Angle. The study will collect data on delivery outcomes, including mode of delivery and neonatal health indicators, to determine the success of the maneuver. The goal is to identify predictors that could improve the chances of a successful version and reduce risks associated with breech presentations.
Who should consider this trial
Good fit: Ideal candidates are women over 18 years of age with a single breech pregnancy at term.
Not a fit: Patients with conditions such as oligohydramnios, placenta previa, or contraindications to vaginal delivery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and outcomes of vaginal deliveries for breech-presenting fetuses.
How similar studies have performed: Previous studies have shown varying success rates with similar ultrasound-based approaches to assess breech presentations, indicating potential for this methodology.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Oligohydramnios: maximum flap \< 2cm * Placenta previa * Uterine malformations * Regular uterine dynamics * Metrorrhagia * Contraindications to vaginal delivery * Premature rupture of membranes * Nonreassuring cardiotocographic tracing * Previous uterine surgery
Where this trial is running
Bologna, Bologna and 1 other locations
- Ospedale Maggiore Carlo Alberto Pizzardi — Bologna, Bologna, Italy (Recruiting)
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD
- Email: aly.youssef@aosp.bo.it
- Phone: 0512144412
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.