Ultrasound Therapy; ComplicationsNCT04862182
Intrapartum Ultrasound in Predicting Mode of Delivery
An observational study of Ultrasound Therapy; Complications, run by Cairo University.
Trial summary
Determine the value of intrapartum scan measurement(s) in predicting the mode of delivery. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Ultrasound Therapy; Complications
- What is being tested?
- Trans-perineal ultrasound
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to Jun 2022
- 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 to 40 years
- Women only
- Adult
Study population: Women who present to the labour ward in the first stage of labour and willing to participate in the study.
Who may be able to join
- Nulliparous women
- Full Term pregnancy
- Vertex presentation
- Singleton pregnancy
- In labour
Who cannot join
- Multiparous women
- Preterm labour
- Non vertex presentation
- Multi-fetal pregnancy
- Planned for elective Cesarean Section
- Underlying medical diseases
- Those unwilling to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Value of Intrapartum Ultrasound in Predicting Mode of Delivery
Determine the value of intrapartum scan measurement(s) in predicting the mode of delivery.
Read the detailed description
The assessment and management of progress of labour is based on subjective clinical findings. The diagnosis of delay in labour and decisions regarding the timing and / or type of intervention(s) rely on clinical abdominal examination and digital vaginal assessment of the degree of cervical dilatation, the position of the presenting part of the baby and its station in relation to the maternal pelvis . Several studies have demonstrated the inaccuracy and the lack of consistency in such assessment between different practitioners especially in certain malpositions, malpresentations or with excessive subcutaneous tissue oedema .
One of the important clinical parameters that is assessed in labour is the position of the fetal head. Precise knowledge of fetal occiput position in labour is essential because some malpositions, like a persistent occiput posterior position is associated with higher risk of operative delivery and maternal and perinatal morbidity. The correct determination of head position is crucial before attempting any operative vaginal delivery. Moreover, knowing the exact presentation is also of paramount importance. For example, the differentiation between a face and a brow presentation is important in clinical management particularly that the engaging diameters of the latter presentation are too big in a term baby for a safe vaginal birth to occur, Sonographic assessment of fetal head position is best performed by transabdominal imaging in axial and sagittal planes .
Another parameter that is important in evaluating the progress of labour is the fetal head station. The fetal head station is the level of the fetal head in the birth canal relative to the plane of the maternal ischial spines. Serial clinical assessments by digital vaginal examination give an indication of the progress in head decent throughout the labour process, Sonographic assessment of fetal head station is best performed by transperineal ultrasound in the midsagittal or axial plane .
Several authors reported that ultrasound examination is more accurate and reproducible than clinical examination in the diagnosis of fetal head position and station and in the prediction of arrest of labor . It has also been suggested that ultrasound examination has the potential to stratify women who have a spontaneous vaginal delivery from those who end up having an operative birth Furthermore, it has been demonstrated that it is feasible to rely on ultrasound to predict the outcome of a planned operative vaginal birth .
However, currently, there is no consensus regarding the best timing of intrapartum scanning, at least for some of these measurements. Similar there is no general agreement regarding which measurements should be obtained and how useful if some of these measurements are integrated into a prediction model together with demographic or other clinical parameters.
- Conditions
- Ultrasound Therapy; Complications
- Being tested
- Trans-perineal ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-perineal ultrasoundDiagnostic test
Intrapartum trans-perineal ultrasound in predicting the mode of delivery.
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of intrapartum Cesarean Section
number of women that failed to progress to normal vaginal delivery and need for intrapartum Cesarean Section (ICS)
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ultrasound Therapy; ComplicationsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamal Omar Abdel Ghany hussein, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862182
- Sponsor's protocol ID
- Intrapartum Ultrasound
- Status last verified
- Apr 2021
- First submitted
- 23 Apr 2021
- Last updated
- 29 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barak O, Levy R, Flidel O, Zaks S, Gillor M, Hagay Z, Vaisbuch E. The Routine Use of Intrapartum Ultrasound in Clinical Decision-Making during the Second Stage of Labor - Does It Have Any Impact on Delivery Outcomes? Gynecol Obstet Invest. 2018;83(1):9-14. doi: 10.1159/000455847. Epub 2017 Feb 22.
PubMed 28222431Brunelli E, Del Prete B, Casadio P, Pilu G, Youssef A. The dynamic change of the anteroposterior diameter of the levator hiatus under Valsalva maneuver at term and labor outcome. Neurourol Urodyn. 2020 Nov;39(8):2353-2360. doi: 10.1002/nau.24494. Epub 2020 Aug 31.
PubMed 32865824Sherer DM, Abulafia O. Intrapartum assessment of fetal head engagement: comparison between transvaginal digital and transabdominal ultrasound determinations. Ultrasound Obstet Gynecol. 2003 May;21(5):430-6. doi: 10.1002/uog.102.
PubMed 12768551Lipschuetz M, Cohen SM, Lewkowicz AA, Amsalem H, Haj Yahya R, Levitt L, Yagel S. [PROLONGED SECOND STAGE OF LABOR: CAUSES AND OUTCOMES]. Harefuah. 2018 Nov;157(11):685-690. Hebrew.
PubMed 30457229
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Intrapartum Ultrasound in Predicting Mode of Delivery
- ClinicalTrials.gov ID
- NCT04862182
- Acronym / sponsor ID
- Intrapartum Ultrasound
- Conditions
- Ultrasound Therapy; Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 27 Apr 2021 (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.
Determine the value of intrapartum scan measurement(s) in predicting the mode of delivery.
Detailed description
The assessment and management of progress of labour is based on subjective clinical findings. The diagnosis of delay in labour and decisions regarding the timing and / or type of intervention(s) rely on clinical abdominal examination and digital vaginal assessment of the degree of cervical dilatation, the position of the presenting part of the baby and its station in relation to the maternal pelvis . Several studies have demonstrated the inaccuracy and the lack of consistency in such assessment between different practitioners especially in certain malpositions, malpresentations or with excessive subcutaneous tissue oedema .
One of the important clinical parameters that is assessed in labour is the position of the fetal head. Precise knowledge of fetal occiput position in labour is essential because some malpositions, like a persistent occiput posterior position is associated with higher risk of operative delivery and maternal and perinatal morbidity. The correct determination of head position is crucial before attempting any operative vaginal delivery. Moreover, knowing the exact presentation is also of paramount importance. For example, the differentiation between a face and a brow presentation is important in clinical management particularly that the engaging diameters of the latter presentation are too big in a term baby for a safe vaginal birth to occur, Sonographic assessment of fetal head position is best performed by transabdominal imaging in axial and sagittal planes .
Another parameter that is important in evaluating the progress of labour is the fetal head station. The fetal head station is the level of the fetal head in the birth canal relative to the plane of the maternal ischial spines. Serial clinical assessments by digital vaginal examination give an indication of the progress in head decent throughout the labour process, Sonographic assessment of fetal head station is best performed by transperineal ultrasound in the midsagittal or axial plane .
Several authors reported that ultrasound examination is more accurate and reproducible than clinical examination in the diagnosis of fetal head position and station and in the prediction of arrest of labor . It has also been suggested that ultrasound examination has the potential to stratify women who have a spontaneous vaginal delivery from those who end up having an operative birth Furthermore, it has been demonstrated that it is feasible to rely on ultrasound to predict the outcome of a planned operative vaginal birth .
However, currently, there is no consensus regarding the best timing of intrapartum scanning, at least for some of these measurements. Similar there is no general agreement regarding which measurements should be obtained and how useful if some of these measurements are integrated into a prediction model together with demographic or other clinical parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women who present to the labour ward in the first stage of labour and willing to participate in the study.
Key inclusion criteria (5 listed)
- Nulliparous women
- Full Term pregnancy
- Vertex presentation
- Singleton pregnancy
- In labour
Key exclusion criteria (7 listed)
- Multiparous women
- Preterm labour
- Non vertex presentation
- Multi-fetal pregnancy
- Planned for elective Cesarean Section
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 |
|---|---|---|
| Trans-perineal ultrasoundIntrapartum trans-perineal ultrasound in predicting the mode of delivery. | Diagnostic test | – |
Primary outcome
The rate of intrapartum Cesarean Section
Time frame: 3 hours
number of women that failed to progress to normal vaginal delivery and need for intrapartum Cesarean Section (ICS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Results publication: PubMed 28222431Barak O, Levy R, Flidel O, Zaks S, Gillor M, Hagay Z, Vaisbuch E. The Routine Use of Intrapartum Ultrasound in Clinical Decision-Making during the Second Stage of Labor - Does It Have Any Impact on Delivery Outcomes? Gynecol Obstet Invest. 2018;83(1):9-14. doi: 10.1159/000455847. Epub 2017 Feb 22.
- Results publication: PubMed 32865824Brunelli E, Del Prete B, Casadio P, Pilu G, Youssef A. The dynamic change of the anteroposterior diameter of the levator hiatus under Valsalva maneuver at term and labor outcome. Neurourol Urodyn. 2020 Nov;39(8):2353-2360. doi: 10.1002/nau.24494. Epub 2020 Aug 31.
- Results publication: PubMed 12768551Sherer DM, Abulafia O. Intrapartum assessment of fetal head engagement: comparison between transvaginal digital and transabdominal ultrasound determinations. Ultrasound Obstet Gynecol. 2003 May;21(5):430-6. doi: 10.1002/uog.102.
- Results publication: PubMed 30457229Lipschuetz M, Cohen SM, Lewkowicz AA, Amsalem H, Haj Yahya R, Levitt L, Yagel S. [PROLONGED SECOND STAGE OF LABOR: CAUSES AND OUTCOMES]. Harefuah. 2018 Nov;157(11):685-690. Hebrew.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound Therapy; Complications, run by Cairo University.
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 5 inclusion and 7 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 29 Apr 2021. 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 Gamal Omar hussein, Specialist (01112677418, gamalomar448@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of intrapartum Cesarean Section (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04862182, which also lists 4 linked publications.
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 29 Apr 2021.