ITUSR: Intrapartum Translabial Ultrasonography Reliability

Sponsor
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04844437
Collaborator
(none)
80
1
19.3
4.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Transperineal ultrasound

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
80 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Intrapartum Translabial Ultrasonography Reliability in Comparison With Traditional Digital Examination
Actual Study Start Date :
Feb 20, 2021
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital Istanbul Turkey

Sponsors and Collaborators

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

Investigators

  • Study Director: Murat Yassa, MD, Specialist

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Arzu Bilge Tekin, Specialist, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04844437
Other Study ID Numbers:
  • ITUSR
First Posted:
Apr 14, 2021
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Arzu Bilge Tekin, Specialist, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2022