IntrapartumNCT06177080
Transperineal Ultrasound and the Place of Sonopartograph in Travay Follow-up in Term Pregnancy
A study testing transperineal ultrasound in people with Intrapartum and Transperineal Ultrasound, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Investigators aimed to determine the progression of the descent angle and head symphysis distance measured by intrapartum transperineal ultrasound as an alternative to vaginal examination and bishop score, according to time and cervical dilatation and to draw a sonopartograph as a new indicator also aimed to evaluate… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrapartum, Transperineal Ultrasound
- What is being tested?
- transperineal ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 1 Jul 2022
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- multiparous pregnancy
- active phase in labor
- vertex position
Who cannot join
- multiple pregnancy
- BMI over 35
- preterm labor
- congenital anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Active Phase of Delivery by Transperineal Ultrasound and the Place of Sonopartograph in Travay Follow-up in Term Pregnancy
Investigators aimed to determine the progression of the descent angle and head symphysis distance measured by intrapartum transperineal ultrasound as an alternative to vaginal examination and bishop score, according to time and cervical dilatation and to draw a sonopartograph as a new indicator also aimed to evaluate the success of the use of transperineal ultrasound in the active phase of labor in predicting prolonged labor, duration and mode of of delivery.
Read the detailed description
Descent angle and head symphysis distances by transperineal ultrasound of pregnant women who are in the active phase of labor was measured hourly in the first phase of the active phase (the period from 4 cm to full dilation of the cervical opening); every 15 minutes in the second phase of the active phase (time from full dilation to delivery of the baby) Cervical dilatation and head levels were noted by simultaneous digital vaginal examination. The physician who performed the imaging and the physician who made the vajinal examination worked independently of each other and did not see each other's results.
- Conditions
- Intrapartum, Transperineal Ultrasound
- Being tested
- transperineal ultrasound
- Keywords
- head symphysis distance, angle of progression, sonopartograph
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transperineal ultrasoundOther
descent angle and head symphysis distances by transperineal ultrasound of active phase of labor women.
| Study group | Role | What they receive |
|---|---|---|
| Definitions of active phase angle of progression, head symphysis distance and examination findings | Other | Definitions of active phase AOP and HSD and examination findings measured in each period according to the type of birth Receives: Other: transperineal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transperineal ultrasound instead of digital vaginal examination
use of transperineal ultrasound in the active phase of labor in predicting prolonged labor, duration and mode of delivery.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start1 Dec 2021
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntrapartumStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 30 nulliparous and 70 multiparous total 100 singleton pregnant women measured descent angle and head symphysis distances by transperineal ultrasound in the active phase of labor.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nefise Nazlı YENIGUL, Sanliurfa Mehmet Akif Inan Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177080
- Sponsor's protocol ID
- 2011-KAEK-252021/10-13
- Status last verified
- Sep 2024
- First submitted
- 11 Dec 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Active Phase of Delivery by Transperineal Ultrasound and the Place of Sonopartograph in Travay Follow-up in Term Pregnancy
- ClinicalTrials.gov ID
- NCT06177080
- Acronym / sponsor ID
- 2011-KAEK-252021/10-13
- Conditions
- Intrapartum, Transperineal Ultrasound
- Keywords
- head symphysis distance, angle of progression, sonopartograph
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 20 Dec 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.
Investigators aimed to determine the progression of the descent angle and head symphysis distance measured by intrapartum transperineal ultrasound as an alternative to vaginal examination and bishop score, according to time and cervical dilatation and to draw a sonopartograph as a new indicator also aimed to evaluate the success of the use of transperineal ultrasound in the active phase of labor in predicting prolonged labor, duration and mode of of delivery.
Detailed description
Descent angle and head symphysis distances by transperineal ultrasound of pregnant women who are in the active phase of labor was measured hourly in the first phase of the active phase (the period from 4 cm to full dilation of the cervical opening); every 15 minutes in the second phase of the active phase (time from full dilation to delivery of the baby) Cervical dilatation and head levels were noted by simultaneous digital vaginal examination. The physician who performed the imaging and the physician who made the vajinal examination worked independently of each other and did not see each other's results.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 30 nulliparous and 70 multiparous total 100 singleton pregnant women measured descent angle and head symphysis distances by transperineal ultrasound in the active phase of labor.
| Arm | Type | Receives |
|---|---|---|
| Definitions of active phase angle of progression, head symphysis distance and examination findings | Other | Other: transperineal ultrasoundDefinitions of active phase AOP and HSD and examination findings measured in each period according to the type of birth |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- multiparous pregnancy
- active phase in labor
- vertex position
Key exclusion criteria (4 listed)
- multiple pregnancy
- BMI over 35
- preterm labor
- congenital anomalies
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 |
|---|---|---|
| transperineal ultrasounddescent angle and head symphysis distances by transperineal ultrasound of active phase of labor women. | Other | Definitions of active phase angle of progression, head symphysis distance and examination findings |
Primary outcome
Transperineal ultrasound instead of digital vaginal examination
Time frame: 7 months
use of transperineal ultrasound in the active phase of labor in predicting prolonged labor, duration and mode of delivery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transperineal ultrasound in people with Intrapartum and Transperineal Ultrasound, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 19 Sep 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Transperineal ultrasound instead of digital vaginal examination (time frame: 7 months). 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 19 Sep 2024.