Intrapartum Translabial Ultrasonography Reliability

Active, not recruiting

• Conditions: Ultrasound Therapy; Complications; Delivery Problem for Fetus; Labour;Obstructed; Progression
• Interventions: Diagnostic Test: Transperineal ultrasound

• Registration Number: NCT04844437
• Lead Sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Brief Summary

In a present study vaginal examination of the fetal head station is compared with transperineal ultrasonography evaluation of fetal head station and the ability of ultrasonography evaluation in predicting the time and mode of delivery will be investigated.

Detailed Description

The sonographically measured head station, 'ITU station', was measured along the longest visible axis of the fetal head, between the intersections with the infra pubic line and the deepest bony part of the fetal head, subtracting 3 cm for the level of the ischial spines. This parameter is useful to determine the level of engagement of the fetal head and its progression throughout labor.

The labor is divided into a latent phase (stage 0), an active phase (stage 1 and 2), and a third stage defined as the time period between the delivery of the baby and the delivery of the placenta. According to the classic definition, the onset of labor is when regular contractions have been established. The latent phase is characterized by painful contractions and cervical dilatation up to 5 cm in accordance with WHO.

The fetal descent in the birth canal is assessed by vaginal digital examinations and related to the ischial spine. ACOG has defined five stations above (-5) and below (+5) the level of the spine (0 stations). Minus five corresponds to the pelvic inlet, zero to the level of the ischial spine, and plus four corresponds to the pelvic floor.

Traditionally, labor progression has been assessed by digital examination of cervical dilatation and fetal descent. Recent studies, however, dispute these findings and found the clinical examination of fetal descent and position to be unprecise and subjective with a high interobserver variation. Dupuis et al. made an important contribution to this debate when he rigorously assessed the accuracy of station diagnosis with digital examinations. . This study provides evidence that digital assessment of fetal head station is unreliable.

However, a study from 2019 found a good correlation between clinical assessments and ultrasound examinations when only one experienced clinician and one trained ultrasound examiner compared their results.

In this study, we aim to evaluate the accuracy of and consistency between vaginal examination and transperineal ultrasound head station measurements.

Study Timeline

• Study Start: 2021-02-20
• Study First Submitted: 2021-04-10
• Study First Submitted QC: 2021-04-10
• Study First Posted: 2021-04-14
• Primary Completion: 2022-09-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-20
• Last Update Posted: 2023-03-21
• Study Completion: 2023-03-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• At or over 36 weeks pregnant women
• Pregnant women at the active phase of the first stage of labor
• Pregnant women at the second stage of labor

Exclusion Criteria

• Breech presentation
• Fetal anomaly
• In utero ex fetus cases
• Trial of labor after cesarean cases
• Pregnant women at the latent phase of the first sage of labor

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transperineal assessment of fetal head decent in pregnant women	Transperineal ultrasound	Pregnant women at 36 weeks or over gestational age in the active phase of the first stage or second stage of labor were examined by transperineal ultrasound and fetal head station evaluated by two experienced clinicians.

Primary Outcome Measures

Name	Time	Method
Acuracy of the fetal head progression distance	At any time in active phase of first stage or second stage of labor	Transperineal measurement of fetal head station will be compared with vaginal examination of fetal head descent and these two measurements correlated with delivery outcomes

Secondary Outcome Measures

Name	Time	Method
Interobserver agreement between vaginal examination fetal head station	At any time in active phase of first stage or second stage of labor	The examination of fetal head levels by two clinicians compared with eachother.
Interobserver agreement between ultrasonographic fetal head station measurement	At any time in active phase of first stage or second stage of labor	The correlation between two clinicians in measuring ultrasonographic fetal head station.

Trial Locations

Locations (1)

Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital; 🇹🇷 Istanbul, Turkey