Clinical trial NCT04532086: Uterocervical Angle and Preterm Labour
Official title: Relationship Between Uterocervical Angle and Prediction of Spontaneous Preterm Birth
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Labor
Keywords: uterocervical angle
Preterm birth
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 197
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gestational age at birth
timeFrame: 6 months
Secondary outcomes:
measure: Apgar score at 1 and 5 minutes
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Lecturer
name: Osama Is Kamel, lecturer
role: STUDY_DIRECTOR
affiliation: Professor
name: Wessam Mg Abuelghar, Professor
role: STUDY_DIRECTOR
affiliation: Professor
name: Ahmed Kh Makled, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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):1784. doi: 10.3390/jcm9061784.
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.