Actively Recruiting
Prediction of Version Outcomes for External Maneuvers of Breech Fetus by Assessment of Breech Progression Angle
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-02-10
200
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore the use of transperineal ultrasound to assess fetal head progression in women with breech fetus presentations at term. Breech presentation complicates about 3-4% of single pregnancies near delivery and is linked with higher risks for the baby. The study focuses on measuring the Breech Progression Angle (BPA) and its potential role in predicting the success of external cephalic version maneuvers, which are procedures to turn the fetus to a head-down position. Participants will undergo ultrasound evaluations before the external version maneuver. These include transabdominal ultrasound to assess fetal presentation, estimated weight, amniotic fluid, placenta position, and fetal spine angle. Transperineal ultrasound will measure the BPA and Subpubic Arch. If the version is successful, another ultrasound will measure the Angle of Progression (AoP). Data about delivery mode, any operative interventions, newborn blood pH, and NICU admissions will be collected from medical records. During the study, participants will be monitored with ultrasound evaluations and their delivery outcomes recorded. Researchers will evaluate new ultrasound indexes like BPA to understand their value in predicting version success. The study includes women aged 18 to 45 with single pregnancies at term and breech presentation. Participation involves ultrasound scans before and possibly after the version procedure, with follow-up data collected after delivery as part of routine care.
CONDITIONS
Brief Title
Prediction of Version Outcomes for External Maneuvers of Breech Fetus by Assessment of Breech Progression Angle
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women over 18 years old with a single pregnancy at term (37-42 weeks) and a fetus in breech presentation
- Signed informed consent form
You will not qualify if you...
- Oligohydramnios with maximum amniotic fluid flap less than 2 cm
- Placenta previa
- Uterine malformations
- Regular uterine contractions
- Metrorrhagia
- Contraindications to vaginal delivery
- Premature rupture of membranes
- Nonreassuring cardiotocographic tracing
- Previous uterine surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - A few hours on the day of the external maneuver
Participants undergo ultrasound evaluations before the external maneuver version of the breech fetus to assess fetal position and other parameters.
1 visit (in-person)
Duration - Up to delivery and shortly after birth
After delivery, participants' medical records are reviewed to collect data on delivery outcomes and newborn health as part of routine care.
Trial Site Locations
Total: 2 locations
1
Ospedale Maggiore Carlo Alberto Pizzardi
Bologna, Bologna, Italy, 40133
Actively Recruiting
2
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy, 40138
Actively Recruiting
Research Team
A
Aly Mohamed Alaaeldin Kamaleldin Aly Youssef, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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