Uterocervical Angle and Preterm Labour

• Conditions: Preterm Labor

• Registration Number: NCT04532086
• Lead Sponsor: Ain Shams Maternity Hospital

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.

Study Timeline

• Study First Submitted: 2020-08-26
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-13
• Last Update Posted: 2020-11-16
• Study Start: 2020-11-20
• Primary Completion: 2021-08
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 197

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gestational age at birth	6 months	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).

Secondary Outcome Measures

Name	Time	Method
Apgar score at 1 and 5 minutes	6 months	Appearance (skin color) Pulse (heart rate) Grimace response (reflexes) Activity (muscle tone) Respiration (breathing rate and effort)