NCT07736183

Brief 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 compared with simultaneous vaginal examination.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
Last Updated

July 30, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

April 5, 2026

Last Update Submit

July 25, 2026

Conditions

Transperineal UltrasoundEpisiotomy

Keywords

transperineal ultrasounddeliveryultrasoundintrapartumepisiotomy

Outcome Measures

Primary Outcomes (1)

  • 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.

    Onset of active labor - 1st week postpartum

Secondary Outcomes (1)

  • Mode of delivery (vaginal delivery vs cesarean section)

    during labor

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswoman
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

primiparous

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sbü Gaziosmanpaşa Eah

Istanbul, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2026

First Posted

July 30, 2026

Study Start

June 1, 2024

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

July 30, 2026

Record last verified: 2026-03

Locations

TU(1)