Uterocervical Angle and Preterm Labour

Relationship Between Uterocervical Angle and Prediction of Spontaneous Preterm Birth

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

Study Overview

• Status: Unknown
• Conditions: Preterm Labor
• Intervention / Treatment: Diagnostic test: Uterocervical angle

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 197

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

197 pregnant women with singleton gestations between (18 - 28) weeks with history of previous preterm deliveries or mid-trimesteric abortions.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital
• Investigators: Study Director: Osama Is Kamel, lecturer, lecturer; Study Director: Wessam Mg Abuelghar, Professor, Professor; Study Director: Ahmed Kh Makled, Professor, Professor

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 20, 2020
• Primary Completion (ANTICIPATED): August 1, 2021
• Study Completion (ANTICIPATED): September 1, 2021

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (ACTUAL): August 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2020
• Last Update Submitted That Met QC Criteria: November 13, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Preterm birth; uterocervical angle
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Premature Birth; Obstetric Labor, Premature
• Other Study ID Numbers: UCA in preterm birth

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No