Uterocervical Angle and Preterm Labour

Preterm Labor Clinical Trial

Official title:

Relationship Between Uterocervical Angle and Prediction of Spontaneous Preterm Birth

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04532086
• Other study ID #: UCA in preterm birth
• Status: Not yet recruiting
• Start date: November 20, 2020
• Est. completion date: September 2021

Study information

• Verified date: November 2020
• Source: Ain Shams Maternity Hospital
• Contact: Mohammed Sh Abd Al Razik
• Phone: +2001098988160
• Email: drmuscle90[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 197
• Est. completion date: September 2021
• Est. primary completion date: August 2021
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Labor

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

References & Publications (4)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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). pii: E1784. doi: 10.3390/jcm9061784. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational age at birth	Preterm labour is defined as regular contractions of the uterus resulting in changes in the cervix that start before 37 weeks of pregnancy. Changes in the cervix include effacement (the cervix thins out) and dilation (the cervix opens so that the fetus can enter the birth canal).	6 months
Secondary	Apgar score at 1 and 5 minutes	Appearance (skin color) Pulse (heart rate) Grimace response (reflexes) Activity (muscle tone) Respiration (breathing rate and effort)	6 months