An observational study in Labour;Obstructed, Progression and Delivery Problem for Fetus, sponsored by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital. Status unknown at 1 site in Turkey. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-21.
Sponsored by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital · Observational
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.
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.
55 studies on the registry are indexed under Dystocia; 12 are open to participants now.
This study's planned enrollment of 80 is below the median of 212 across 12 observational studies indexed under Dystocia.
Browse Dystocia studies →Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital is the lead sponsor of 41 studies on the registry; 14 are open to participants now.
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Pregnant women at 36 weeks or over gestational weeks at the active phase of the first stage and the second stage of labor.
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Exclusion Criteria:
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.
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.
Acuracy of the fetal head progression distance
Transperineal measurement of fetal head station will be compared with vaginal examination of fetal head descent and these two measurements correlated with delivery outcomes
Time frame: At any time in active phase of first stage or second stage of labor
Interobserver agreement between vaginal examination fetal head station
The examination of fetal head levels by two clinicians compared with eachother.
Time frame: At any time in active phase of first stage or second stage of labor
Interobserver agreement between ultrasonographic fetal head station measurement
The correlation between two clinicians in measuring ultrasonographic fetal head station.
Time frame: At any time in active phase of first stage or second stage of labor
Ran from Feb 2021 to primary completion in Sep 2022, 19 months.
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This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital