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Uterocervical Angle and Preterm Labour

NCT ID: NCT04532086

Last Updated: 2020-11-16

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

197 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-20

Study Completion Date

2021-09-30

Brief Summary

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To determine whether a novel ultrasonographic marker, uterocervical angle, correlates with risk of spontaneous preterm birth

Detailed Description

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The uterocervical angle is the triangular segment measured between the lower uterine segment and the cervical canal, yielding a measurable angle. The first ray was placed from the internal os to the external os. The calipers were placed where the anterior and posterior walls of the cervix touch the internal and external os along the endocervical canal. If the cervix was curved, the first ray was also drawn from the internal os to the external os as a straight line. A second ray was then drawn to delineate the lower uterine segment. This ray was traced up the anterior uterine segment to a distance allowed by the preloaded image. Ideally, the second ray would reach 3cm up the lower uterine segment in order to establish an adequate measurement. The anterior angle in between the two rays was measured with a protractor. In the presence of funneling, the first ray was placed to measure the length of remaining cervix. The second caliper was placed from the innermost portion of measurable cervix and extended to the lower uterine segment. In the event that the lower uterine segment was found to be irregular, the second caliper was placed centrally along the segment. In the event of a retroverted uterus, the angle should be measured in a similar fashion with the first ray along the measurable cervix and the second ray traced along the lower uterine segment. Unlike in an anteverted or axial positioned uterus, however, the posterior side of the angle closer to the intrauterine contents should then be measured.

Conditions

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Preterm Labor

Keywords

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uterocervical angle Preterm birth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Uterocervical angle

Transvaginal ultrasound examination will be performed at 18-28 weeks gestation in (197) pregnant women with live singleton fetuses, attending routine prenatal care services. Measuring length of uterine cervix at (18-28) weeks \& evaluation of dilatation of internal os \& measurement of uterocervical angle between(18-28)weeks gestational age.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Maternal age (18\_40).
* BMI (20\_34).
* singleton gestations between (18 - 28) weeks.
* Multiparity.
* History of previous preterm deliveries or mid-trimesteric abortions.

Exclusion Criteria

* Loss of follow up.
* Preterm premature rupture of membranes(PPROM).
* Placental abnormalities.
* Past history of cervical operations.
* Multifetal pregnancy.
* Polyhydramnios.
* Steroids intake .
* Medically or obstetric indicated pregnancy termination.
* Serious maternal or fetal problems.
* Cerclage during current pregnancy before the screening.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams Maternity Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Shaaban Abd Al Razik Ibrahim

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Osama Is Kamel, lecturer

Role: STUDY_DIRECTOR

Lecturer

Wessam Mg Abuelghar, Professor

Role: STUDY_DIRECTOR

Professor

Ahmed Kh Makled, Professor

Role: STUDY_DIRECTOR

Professor

Central Contacts

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Mohammed Sh Abd Al Razik

Role: CONTACT

Phone: +2001098988160

Email: [email protected]

References

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Daskalakis G, Theodora M, Antsaklis P, Sindos M, Grigoriadis T, Antsaklis A, Papantoniou N, Loutradis D, Pergialiotis V. Assessment of Uterocervical Angle Width as a Predictive Factor of Preterm Birth: A Systematic Review of the Literature. Biomed Res Int. 2018 Dec 26;2018:1837478. doi: 10.1155/2018/1837478. eCollection 2018.

Reference Type BACKGROUND
PMID: 30687736 (View on PubMed)

Swanson K, Grobman WA, Miller ES. Is Uterocervical Angle Associated with Gestational Latency after Physical Exam Indicated Cerclage? Am J Perinatol. 2018 Jul;35(9):840-843. doi: 10.1055/s-0037-1621734. Epub 2018 Jan 24.

Reference Type BACKGROUND
PMID: 29365330 (View on PubMed)

van der Merwe J, Couck I, Russo F, Burgos-Artizzu XP, Deprest J, Palacio M, Lewi L. The Predictive Value of the Cervical Consistency Index to Predict Spontaneous Preterm Birth in Asymptomatic Twin Pregnancies at the Second-Trimester Ultrasound Scan: A Prospective Cohort Study. J Clin Med. 2020 Jun 8;9(6):1784. doi: 10.3390/jcm9061784.

Reference Type BACKGROUND
PMID: 32521741 (View on PubMed)

Oskovi Kaplan ZA, Ozgu-Erdinc AS. Prediction of Preterm Birth: Maternal Characteristics, Ultrasound Markers, and Biomarkers: An Updated Overview. J Pregnancy. 2018 Oct 10;2018:8367571. doi: 10.1155/2018/8367571. eCollection 2018.

Reference Type BACKGROUND
PMID: 30405914 (View on PubMed)

Other Identifiers

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UCA in preterm birth

Identifier Type: -

Identifier Source: org_study_id