Clinical trial NCT04844437: Intrapartum Translabial Ultrasonography Reliability
Official title: Intrapartum Translabial Ultrasonography Reliability in Comparison With Traditional Digital Examination
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Labour;Obstructed
Progression
Delivery Problem for Fetus
Ultrasound Therapy; Complications
Keywords: labor
intrapartum ultrasonography
head station
Lead sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acuracy of the fetal head progression distance
timeFrame: At any time in active phase of first stage or second stage of labor
Secondary outcomes:
measure: Interobserver agreement between vaginal examination fetal head station
timeFrame: At any time in active phase of first stage or second stage of labor
measure: Interobserver agreement between ultrasonographic fetal head station measurement
timeFrame: At any time in active phase of first stage or second stage of labor
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital
Study officials:
affiliation: Specialist
name: Murat Yassa, MD
role: STUDY_DIRECTOR
References:
citation: Ciaciura-Jarno M, Cnota W, Wojtowicz D, Niesluchowska-Hoxha A, Ruci A, Kierach R, Stepien A, Nowak A, Sodowska P. Evaluation of selected ultrasonography parameters in the second stage of labor in prediction mode of delivery. Ginekol Pol. 2016;87(6):448-53. doi: 10.5603/GP.2016.0024.
citation: Akmal S, Kametas N, Tsoi E, Hargreaves C, Nicolaides KH. Comparison of transvaginal digital examination with intrapartum sonography to determine fetal head position before instrumental delivery. Ultrasound Obstet Gynecol. 2003 May;21(5):437-40. doi: 10.1002/uog.103.
citation: Ramphul M, Ooi PV, Burke G, Kennelly MM, Said SA, Montgomery AA, Murphy DJ. Instrumental delivery and ultrasound : a multicentre randomised controlled trial of ultrasound assessment of the fetal head position versus standard care as an approach to prevent morbidity at instrumental delivery. BJOG. 2014 Jul;121(8):1029-38. doi: 10.1111/1471-0528.12810. Epub 2014 Apr 11.
citation: Dupuis O, Silveira R, Zentner A, Dittmar A, Gaucherand P, Cucherat M, Redarce T, Rudigoz RC. Birth simulator: reliability of transvaginal assessment of fetal head station as defined by the American College of Obstetricians and Gynecologists classification. Am J Obstet Gynecol. 2005 Mar;192(3):868-74. doi: 10.1016/j.ajog.2004.09.028.
citation: Iversen JK, Jacobsen AF, Mikkelsen TF, Eggebo TM. Structured clinical examinations in labor: rekindling the craft of obstetrics. J Matern Fetal Neonatal Med. 2021 Jun;34(12):1963-1969. doi: 10.1080/14767058.2019.1651283. Epub 2019 Aug 19.