Intrapartum Translabial Ultrasonography Reliability (ITUSR)

March 20, 2023 updated by: Arzu Bilge Tekin, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Intrapartum Translabial Ultrasonography Reliability in Comparison With Traditional Digital Examination

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women at 36 weeks or over gestational weeks at the active phase of the first stage and the second stage of labor.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Digital examination of fetal head decent in pregnant women
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 digital examination and fetal head station evaluated by two clinicians.
Transperineal assessment of fetal head decent in pregnant women
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.
Diagnostic test: Transperineal ultrasound
The fetal head station is evaluated by transperineal ultrasonography in valsalva.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acuracy of the fetal head progression distance
Time Frame: 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
At any time in active phase of first stage or second stage of labor

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interobserver agreement between vaginal examination fetal head station
Time Frame: 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.
At any time in active phase of first stage or second stage of labor
Interobserver agreement between ultrasonographic fetal head station measurement
Time Frame: 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.
At any time in active phase of first stage or second stage of labor

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Investigators

  • Study Director: Murat Yassa, MD, Specialist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2021

Primary Completion (Actual)

September 30, 2022

Study Completion (Anticipated)

March 30, 2023

Study Registration Dates

First Submitted

April 10, 2021

First Submitted That Met QC Criteria

April 10, 2021

First Posted (Actual)

April 14, 2021

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 20, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITUSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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