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Completed

NCT Number: NCT07736183

INTRAPARTUM TRANSPERINEAL ULTRASOUND MEASUREMENT OF HEAD-PERINEUM DISTANCE

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.

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Key information

Conditions

Transperineal Ultrasound Episiotomy

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Sbü Gaziosmanpaşa Eah

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mode of delivery (vaginal delivery vs cesarean section)

    Time frame: during labor

    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.

Sponsors and collaborators

Lead sponsor

Gaziosmanpasa Research and Education Hospital

Other Gov

Registry information

Official study title

INTRAPARTUM TRANSPERINEAL ULTRASOUND MEASUREMENT OF HEAD-PERINEUM DISTANCE TO PREDICT DELIVERY-RELATED MATERNAL OUTCOMES: A PROSPECTIVE COHORT STUDY

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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