Intrapartum Translabial Ultrasonography Reliability

NCT ID: NCT04844437

Last Updated: 2023-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-20

Study Completion Date

2023-03-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

Transperineal ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Transperineal ultrasound

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Arzu Bilge Tekin

Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murat Yassa, MD

Role: STUDY_DIRECTOR

Specialist

Locations

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Sehit Prof Dr Ilhan Varank Sancaktepe Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 27418223 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12768552 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24720273 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15746684 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31422727 (View on PubMed)

Related Links

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https://apps.who.int/iris/bitstream/handle/10665/260178/9789241550215-eng.pdf

World Health Organization. Intrapartum care for a positive childbirth experience. 2018. ISBN 978-92-4-155021-5

https://link.springer.com/chapter/10.1007/978-3-030-57595-3_2

Brief History of Intrapartum Ultrasonography

Other Identifiers

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ITUSR

Identifier Type: -

Identifier Source: org_study_id

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