Intrapartum Translabial Ultrasonography Reliability

NCT04844437 | Unknown

• 1 other identifier: ITUSR
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

labor; intrapartum ultrasonography; head station

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Interobserver agreement between vaginal examination fetal head station

  At any time in active phase of first stage or second stage of labor

• Interobserver agreement between ultrasonographic fetal head station measurement

  At any time in active phase of first stage or second stage of labor

Study Arms (2)

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

Interventions

Transperineal ultrasound DIAGNOSTIC_TEST

The fetal head station is evaluated by transperineal ultrasonography in valsalva.

Transperineal assessment of fetal head decent in pregnant women

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 27418223 BACKGROUND

• 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.

  PMID: 12768552 BACKGROUND

• 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.

  PMID: 24720273 BACKGROUND

• 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.

  PMID: 15746684 BACKGROUND

• 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.

  PMID: 31422727 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Dystocia; Disease Progression

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Murat Yassa, MD

  Specialist

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist

Study Record Dates

• First Submitted: April 10, 2021
• First Posted: April 14, 2021
• Study Start: February 20, 2021
• Primary Completion: September 30, 2022
• Study Completion: March 30, 2023
• Last Updated: March 21, 2023

Record last verified: 2023-03

Locations

TU (1)