Intrapartum Translabial Ultrasonography Reliability

Ultrasound Therapy; Complications Clinical Trial

— ITUSR  

Official title:

Intrapartum Translabial Ultrasonography Reliability in Comparison With Traditional Digital Examination

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04844437
• Other study ID #: ITUSR
• Status: Active, not recruiting
• Start date: February 20, 2021
• Est. completion date: March 30, 2023

Study information

• Verified date: March 2023
• Source: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: March 30, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Delivery Problem for Fetus
• Dystocia
• Labour;Obstructed
• Progression
• Ultrasound Therapy; Complications

Intervention

Diagnostic Test:
• Transperineal ultrasound
The fetal head station is evaluated by transperineal ultrasonography in valsalva.

Locations

Country	Name	City	State
Turkey	Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At any time in active phase of first stage or second stage of labor
Secondary	Interobserver agreement between vaginal examination fetal head station	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
Secondary	Interobserver agreement between ultrasonographic fetal head station measurement	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

External Links

•   Brief History of Intrapartum Ultrasonography
•   World Health Organization. Intrapartum care for a positive childbirth experience. 2018. ISBN 978-92-4-155021-5