Transperineal UltrasoundNCT07736183
INTRAPARTUM TRANSPERINEAL ULTRASOUND MEASUREMENT OF HEAD-PERINEUM DISTANCE
An observational study of Transperineal Ultrasound and Episiotomy, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Intrapartum ultrasonography has been used as a current alternative method to vaginal examination. In this study, the role of head-perineum distance (HPD) measured by transperineal ultrasonography (TPU) at the beginning of the active phase in predicting maternal outcomes related to delivery was investigated and… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Transperineal Ultrasound, Episiotomy
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Sep 2025
- How long will I take part?
- 1 Week
- 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: primiparous
Inclusion Criteria:Patients aged 18 and over, with full-term, primiparous, cephalic presentation fetus, singleton pregnancy, and active labor initiation. -
Exclusion Criteria:Patients with a body mass index of 30 or higher, those who have undergone median episiotomy, those under 18 or over 40 years of age; those with malpresentation, placental placement anomalies, cord prolapse, twin pregnancy; and those with pregnancy-related or pre-existing hemorrhoidal diseases, anal fissures, abscesses, fistulas, rectal prolapse, and anal incontinence are not suitable candidates. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: INTRAPARTUM TRANSPERINEAL ULTRASOUND MEASUREMENT OF HEAD-PERINEUM DISTANCE TO PREDICT DELIVERY-RELATED MATERNAL OUTCOMES: A PROSPECTIVE COHORT STUDY
Intrapartum ultrasonography has been used as a current alternative method to vaginal examination. In this study, the role of head-perineum distance (HPD) measured by transperineal ultrasonography (TPU) at the beginning of the active phase in predicting maternal outcomes related to delivery was investigated and compared with simultaneous vaginal examination.
- Conditions
- Transperineal Ultrasound, Episiotomy
- Keywords
- transperineal ultrasound, delivery, ultrasound, intrapartum, episiotomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between head-perineum distance (HPD) measured by transperineal ultrasound and maternal outcomes
we investigated the association between HPD measured at the onset of the active phase of labour and delivery-related maternal outcomes, with a primary focus on perineal trauma. As secondary objectives, we explored the relationships of HPD with contemporaneous VE findings, mode of delivery, induction of labour, sociocultural indicators and other maternal complications. We hypothesized that HPD at active phase onset is significantly associated with delivery-related maternal outcomes.
Measured: Onset of active labor - 1st week postpartum
Secondary outcomes (1)
Mode of delivery (vaginal delivery vs cesarean section)
A correlation was investigated between the head-perineal distance measured at the onset of active labor and the mode of delivery. The study concluded that an increased head-perineal distance was associated with an increased likelihood of cesarean delivery.
Measured: during labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Jun 2024
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transperineal UltrasoundStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736183
- Sponsor's protocol ID
- GaziosmanpaşaTPUS
- Status last verified
- Mar 2026
- First submitted
- 5 Apr 2026
- Last updated
- 30 Jul 2026
- 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 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTRAPARTUM TRANSPERINEAL ULTRASOUND MEASUREMENT OF HEAD-PERINEUM DISTANCE TO PREDICT DELIVERY-RELATED MATERNAL OUTCOMES: A PROSPECTIVE COHORT STUDY
- ClinicalTrials.gov ID
- NCT07736183
- Acronym / sponsor ID
- GaziosmanpaşaTPUS
- Conditions
- Transperineal Ultrasound, Episiotomy
- Keywords
- transperineal ultrasound, delivery, ultrasound, intrapartum, episiotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 30 Jul 2026 (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.
Intrapartum ultrasonography has been used as a current alternative method to vaginal examination. In this study, the role of head-perineum distance (HPD) measured by transperineal ultrasonography (TPU) at the beginning of the active phase in predicting maternal outcomes related to delivery was investigated and compared with simultaneous vaginal examination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- primiparous
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
Association between head-perineum distance (HPD) measured by transperineal ultrasound and maternal outcomes
Time frame: Onset of active labor - 1st week postpartum
we investigated the association between HPD measured at the onset of the active phase of labour and delivery-related maternal outcomes, with a primary focus on perineal trauma. As secondary objectives, we explored the relationships of HPD with contemporaneous VE findings, mode of delivery, induction of labour, sociocultural indicators and other maternal complications. We hypothesized that HPD at active phase onset is significantly associated with delivery-related maternal outcomes.
1 secondary outcome
Mode of delivery (vaginal delivery vs cesarean section)
Time frame: during labor
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 30 Jul 2026.
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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?
An observational study of Transperineal Ultrasound and Episiotomy, run by Gaziosmanpasa Research and Education 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?
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 30 Jul 2026. 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?
Association between head-perineum distance (HPD) measured by transperineal ultrasound and maternal outcomes (time frame: Onset of active labor - 1st week postpartum). 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 30 Jul 2026.