Ultrasound in LaborEcoSP_21NCT06806904
The Role of Ultrasonography in Labor in Predicting the Outcomes of Childbirth
An observational study of Ultrasound in Labor, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Ultrasound in the delivery room represents a useful diagnostic tool and is used for the assessment of fetal presentation, fetal malpresentation/malposition, and prior to any operative delivery. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Ultrasound in Labor
- How many people
- 116 participants
- Where
- 1 siteItaly
- Study dates
- 31 Aug 2021to 31 Dec 2028
- 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 44 years
- Women only
- No healthy volunteers
- Adult
Study population: It is planned to enroll patients afferent to the Department of Obstetrics and Prenatal Age Medicine, Sant'Orsola-Malpighi Polyclinic.
Who may be able to join
- Women aged >= 18 years
- Single pregnancy at term (37-42 gestational weeks)
- Fetus in cephalic presentation and in expulsive period (complete cervical dilatation and premature sensation)
- Acquisition of informed consent form
Who cannot join
- Placenta previa
- Uterine malformations
- Previous uterine surgery
- Cardiotocographic tracing (CTG) abnormalities
- Any contraindication to vaginal delivery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- 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
Ultrasound in the delivery room represents a useful diagnostic tool and is used for the assessment of fetal presentation, fetal malpresentation/malposition, and prior to any operative delivery. Transperineal ultrasonography, performed by placing the ultrasound probe covered by a sterile glove at the level of the labia majora, has proven useful in providing information on the progression of the presented fetal part in the birth canal and in predicting birth outcomes. Many studies have shown a correlation between the above ultrasound indices and birth outcomes. These ultrasound indices are therefore used in clinical practice to assess the progression of the presented fetal part in the birth canal and the presence of fetal malpresentation/malposition. Despite this, to date, few studies have evaluated the correlation between dynamic changes in these ultrasound parameters between rest and maximal maternal pushing during the second stage of labor and birth outcomes.
Knowing before delivery which parameters are suggestive of possible dystocia would allow the clinician to adopt therapeutic strategies aimed at resolving them and thus increase the rate of spontaneous vaginal deliveries.
The investigators want to evaluate the role of an ultrasound parameter obtained by transabdominal ultrasound in the second stage of labor, the occiput-column angle, in predicting spontaneous delivery vaginally in fetuses with transverse occiput
Read the detailed description
Participants will be recruited at the time of admission or in the delivery room. Routine clinical practice involves transabdominal ultrasound, performed in the lithotomy position, placing the probe transversely and longitudinally at the abdominal level for evaluation of the fetal situation and presentation.
In addition to normal ultrasound, the position of the fetal occiput will also be assessed in women who agree to participate in the study, and in fetuses with a transverse occiput, the occipitecolumn angle will be measured. All study participants will then undergo transperineal ultrasound, performed by placing the probe, covered by a sterile glove, at the level of the labia majora, first longitudinally and then transversely. In this way, a series of ultrasound landmarks will be visualized: pubic symphysis, bladder, urethra, vagina, rectum, pubo-rectal muscle, and fetal head.
- Conditions
- Ultrasound in Labor
- Keywords
- labor
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Angle of Progression (AoP)
Angle of progression (AoP): the angle between the longitudinal axis of the pubic symphysis and a straight line starting from the lower edge of the symphysis and passing tangentially to the most distal part of the fetal head
Measured: At the time of delivery: at rest and during maternal pushing
Measurement of Anteroposterior Pelvic Hiatus Diameter (APD)
Anteroposterior pelvic hiatus diameter (APD): distance between the posteroinferior margin of the pubic symphysis and the anterior margin of the pubo-rectal muscle
Measured: At the time of delivery: at rest and during maternal pushing
Measurement of Head-Sympanic Distance (HSD)
Head-symphysis distance (HSD): distance between the lower edge of the pubic symphysis and the nearest point of the fetal scalp along the infrapubic line
Measured: At the time of delivery: at rest and during maternal pushing
Measurement of Head-Perineum Distance (HPD)
Head-Perineum Distance (HPD): distance between the perineum and the nearest point of the fetal scalp
Measured: At the time of delivery: at rest and during maternal pushing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start31 Aug 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound in LaborStudies 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
- 116 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
- NCT06806904
- Sponsor's protocol ID
- EcoSP_21
- Acronym
- EcoSP_21
- Status last verified
- Nov 2024
- First submitted
- 30 Dec 2024
- Last updated
- 4 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 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Ultrasonography in Labor in Predicting the Outcomes of Childbirth
- ClinicalTrials.gov ID
- NCT06806904
- Acronym / sponsor ID
- EcoSP_21 / EcoSP_21
- Conditions
- Ultrasound in Labor
- Keywords
- labor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 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.
Ultrasound in the delivery room represents a useful diagnostic tool and is used for the assessment of fetal presentation, fetal malpresentation/malposition, and prior to any operative delivery. Transperineal ultrasonography, performed by placing the ultrasound probe covered by a sterile glove at the level of the labia majora, has proven useful in providing information on the progression of the presented fetal part in the birth canal and in predicting birth outcomes. Many studies have shown a correlation between the above ultrasound indices and birth outcomes. These ultrasound indices are therefore used in clinical practice to assess the progression of the presented fetal part in the birth canal and the presence of fetal malpresentation/malposition. Despite this, to date, few studies have evaluated the correlation between dynamic changes in these ultrasound parameters between rest and maximal maternal pushing during the second stage of labor and birth outcomes.
Knowing before delivery which parameters are suggestive of possible dystocia would allow the clinician to adopt therapeutic strategies aimed at resolving them and thus increase the rate of spontaneous vaginal deliveries.
The investigators want to evaluate the role of an ultrasound parameter obtained by transabdominal ultrasound in the second stage of labor, the occiput-column angle, in predicting spontaneous delivery vaginally in fetuses with transverse occiput
Detailed description
Participants will be recruited at the time of admission or in the delivery room. Routine clinical practice involves transabdominal ultrasound, performed in the lithotomy position, placing the probe transversely and longitudinally at the abdominal level for evaluation of the fetal situation and presentation.
In addition to normal ultrasound, the position of the fetal occiput will also be assessed in women who agree to participate in the study, and in fetuses with a transverse occiput, the occipitecolumn angle will be measured. All study participants will then undergo transperineal ultrasound, performed by placing the probe, covered by a sterile glove, at the level of the labia majora, first longitudinally and then transversely. In this way, a series of ultrasound landmarks will be visualized: pubic symphysis, bladder, urethra, vagina, rectum, pubo-rectal muscle, and fetal head.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- It is planned to enroll patients afferent to the Department of Obstetrics and Prenatal Age Medicine, Sant'Orsola-Malpighi Polyclinic.
Key inclusion criteria (4 listed)
- Women aged >= 18 years
- Single pregnancy at term (37-42 gestational weeks)
- Fetus in cephalic presentation and in expulsive period (complete cervical dilatation and premature sensation)
- Acquisition of informed consent form
Key exclusion criteria (5 listed)
- Placenta previa
- Uterine malformations
- Previous uterine surgery
- Cardiotocographic tracing (CTG) abnormalities
- Any contraindication to vaginal delivery
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
Measurement of Angle of Progression (AoP)
Time frame: At the time of delivery: at rest and during maternal pushing
Angle of progression (AoP): the angle between the longitudinal axis of the pubic symphysis and a straight line starting from the lower edge of the symphysis and passing tangentially to the most distal part of the fetal head
Measurement of Anteroposterior Pelvic Hiatus Diameter (APD)
Time frame: At the time of delivery: at rest and during maternal pushing
Anteroposterior pelvic hiatus diameter (APD): distance between the posteroinferior margin of the pubic symphysis and the anterior margin of the pubo-rectal muscle
Measurement of Head-Sympanic Distance (HSD)
Time frame: At the time of delivery: at rest and during maternal pushing
Head-symphysis distance (HSD): distance between the lower edge of the pubic symphysis and the nearest point of the fetal scalp along the infrapubic line
Measurement of Head-Perineum Distance (HPD)
Time frame: At the time of delivery: at rest and during maternal pushing
Head-Perineum Distance (HPD): distance between the perineum and the nearest point of the fetal scalp
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 4 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound in Labor, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site 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 4 inclusion and 5 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 4 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 1 site 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?
Measurement of Angle of Progression (AoP) (time frame: At the time of delivery: at rest and during maternal pushing). The study lists 4 primary outcomes in all. 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 4 Feb 2025.