Progress pf LaborNCT05823610
Intrapartum Ultrasonography in Evaluation of the Progress of Labor
An observational study of Progress pf Labor, run by Assiut University.
Trial summary
The optimal management of the second stage of labor is a subject of an ongoing debate. It is well established that prolonged second stage of labor is associated with increased maternal and neonatal morbidity. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Progress pf Labor
- What is being tested?
- ultrasound
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Sep 2025
- 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
- No healthy volunteers
- Adult
Study population: women presented in labor
Who may be able to join
- Primigravida patients
- At the onset of active phase
- Cephalic vertex presentation
- Estimated Fetal Weight 3Kg - 4Kg
- Gestational Age ≥37 weeks
Who cannot join
- Multiple Pregnancy
- Patients refused to participate in our study
- Induced labor
- Any Obstetrical Complication or Disease
- Malpresentation
About this study
The optimal management of the second stage of labor is a subject of an ongoing debate. It is well established that prolonged second stage of labor is associated with increased maternal and neonatal morbidity.
Diagnosing the onset of labour is one of the most critical and complex judgments made by care providers in the delivery room. Measurement of cervical dilatation is considered the most crucial parameter for labour progress during childbirth and the main reason for doing digital vaginal examination (DVE) in women with signs of labour onset.
DVE was the most common method for measuring cervical dilatation in the past and has been the gold standard for assessing labour progress. However, it can be subjective, inaccurate, and uncomfortable for women. Also, only 50% of assessments are accurate, and there is an increased risk of infection with frequent DVE. Therefore, vaginal examination cannot be a correct scale for measuring cervical dilatation, mainly when done by different examiners. Because of the poor reliability and pain associated with DVE, the use of intrapartum ultrasound to measure cervical dilation has been suggested as an alternative method. Abdominal, vaginal, trans-labial, and trans-perineal 2D and 3D ultrasounds have been used to measure cervical dilatation during labour.
- Conditions
- Progress pf Labor
- Being tested
- ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDiagnostic test
The ultrasound parameters to be collected included the angle of progression, head-perineum distance and head-symphysis distance at rest and while pushing during contraction and the data between measurements taken at rest and while pushing. Also anatomical scanning for the episiotomy, perineal tears and obstetric anal sphincter injuries (OASI), also trauma to the levator ani muscle. All demographic, clinical and ultrasound variables were compared between women who had a spontaneous vaginal delivery (SVD) and those who eventually had an operative delivery (OD), vacuum -assisted or cesarean section (CS).
| Study group | Role | What they receive |
|---|---|---|
| study group | The ultrasound parameters to be collected included the angle of progression, head-perineum distance and head-symphysis distance at rest and while pushing during contraction and the data between measurements taken at rest and while pushing. Also anatomical scanning for the episiotomy, perineal tears and obstetric anal sphincter injuries (OASI), also trauma to the levator ani muscle. All demographic, clinical and ultrasound variables were compared between women who had a spontaneous vaginal delivery (SVD) and those who eventually had an operative delivery (OD), vacuum -assisted or cesarean section (CS). Receives: Diagnostic Test: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the intrapartum sonographic parameters between women who had spontaneous vaginal delivery (SVD) vs those who required CS
Ultrasound evaluation of the parameters of progress of labour
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study startJun 2023 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progress pf LaborStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823610
- Sponsor's protocol ID
- IPUS
- Status last verified
- Apr 2023
- First submitted
- 9 Apr 2023
- Last updated
- 21 Apr 2023
- 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 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrapartum Ultrasonography in Evaluation of the Progress of Labor
- ClinicalTrials.gov ID
- NCT05823610
- Acronym / sponsor ID
- IPUS
- Conditions
- Progress pf Labor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 21 Apr 2023 (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.
The optimal management of the second stage of labor is a subject of an ongoing debate. It is well established that prolonged second stage of labor is associated with increased maternal and neonatal morbidity.
Diagnosing the onset of labour is one of the most critical and complex judgments made by care providers in the delivery room. Measurement of cervical dilatation is considered the most crucial parameter for labour progress during childbirth and the main reason for doing digital vaginal examination (DVE) in women with signs of labour onset.
DVE was the most common method for measuring cervical dilatation in the past and has been the gold standard for assessing labour progress. However, it can be subjective, inaccurate, and uncomfortable for women. Also, only 50% of assessments are accurate, and there is an increased risk of infection with frequent DVE. Therefore, vaginal examination cannot be a correct scale for measuring cervical dilatation, mainly when done by different examiners. Because of the poor reliability and pain associated with DVE, the use of intrapartum ultrasound to measure cervical dilation has been suggested as an alternative method. Abdominal, vaginal, trans-labial, and trans-perineal 2D and 3D ultrasounds have been used to measure cervical dilatation during labour.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: ultrasoundThe ultrasound parameters to be collected included the angle of progression, head-perineum distance and head-symphysis distance at rest and while pushing during contraction and the data between measurements taken at rest and while pushing. Also anatomical scanning for the episiotomy, perineal tears and obstetric anal sphincter injuries (OASI), also trauma to the levator ani muscle. All demographic, clinical and ultrasound variables were compared between women who had a spontaneous vaginal delivery (SVD) and those who eventually had an operative delivery (OD), vacuum -assisted or cesarean section (CS). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- women presented in labor
Key inclusion criteria (5 listed)
- Primigravida patients
- At the onset of active phase
- Cephalic vertex presentation
- Estimated Fetal Weight 3Kg - 4Kg
- Gestational Age ≥37 weeks
Key exclusion criteria (5 listed)
- Multiple Pregnancy
- Patients refused to participate in our study
- Induced labor
- Any Obstetrical Complication or Disease
- Malpresentation
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 |
|---|---|---|
| ultrasoundThe ultrasound parameters to be collected included the angle of progression, head-perineum distance and head-symphysis distance at rest and while pushing during contraction and the data between measurements taken at rest and while pushing. Also anatomical scanning for the episiotomy, perineal tears and obstetric anal sphincter injuries (OASI), also trauma to the levator ani muscle. All demographic, clinical and ultrasound variables were compared between women who had a spontaneous vaginal delivery (SVD) and those who eventually had an operative delivery (OD), vacuum -assisted or cesarean section (CS). | Diagnostic test | study group |
Primary outcome
compare the intrapartum sonographic parameters between women who had spontaneous vaginal delivery (SVD) vs those who required CS
Time frame: one hour
Ultrasound evaluation of the parameters of progress of labour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Progress pf Labor, run by Assiut 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 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: status not confirmed, as of the sponsor's last update on 21 Apr 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare the intrapartum sonographic parameters between women who had spontaneous vaginal delivery (SVD) vs those who required CS (time frame: one hour). 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 21 Apr 2023.