Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06403059 |
| Other study ID # |
CL in preterm |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 15, 2023 |
| Est. completion date |
April 30, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Beni-Suef University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This prospective study was carried out on 263 pregnant females aged from 19 to 35 years old
carrying singleton, and uncomplicated pregnancy. TVS examination was performed in all cases
at 28 and 32 weeks of gestation. The pregnant women recruited in the study closely followed
up to delivery. Maternal progesterone was given to all women with short CL (<20mm and more
than 10mm) to support pregnancy.
Description:
#Patients and Methods: This prospective cohort study was performed on 263 pregnant females
aged from 19 to 35 years old carrying singleton, and uncomplicated pregnancy.
The study was done after approval from ethical committee. An informed written consent was
obtained from the patient.
With aseptic measures and a high-frequency endo-vaginal 7.5 Hz. probe (GE Logiq P6), TVS
examinations were done to all pregnant women. Dorsal lithotomy posture was applied to
pregnant women who were instructed to evacuate their bladders. Without applying excessive
pressure, the vaginal probe was inserted into the anterior fornix. At maximum magnification,
a sagittal image of the cervix and anterior uterine wall was obtained. We identified the
echogenic endocervical canal with the surrounded less echogenic cervical mucosa zone. The
external os was noted at the junction of the cervix both anterior and posterior lips within
the vaginal canal, but the internal os was situated at the end of the cervical mucosa in the
lower uterine segment. CL and UCA were measured using the ultrasound's built-in angle
caliper. The anterior UCA measurement involved calculating the angle formed by a line running
through the cervix and another line along the lower front segment of the uterus, starting
from the internal os. This was achieved by manually drawing two lines with the angle caliper:
one connecting the internal and external os, and another extending from the internal os along
the lower anterior uterine wall, up to a point 3 cm from the internal os.
The research involved close monitoring of pregnant participants up to the time of delivery.
Demographics and pregnancy outcomes were collected and recorded. PTB was defined as delivery
occurring before 37 complete weeks of gestation [9]. To support pregnancy, maternal
progesterone was administered to all women with a short CL (less than 20mm but more than
10mm). In this study, cervical cerclage was not used in any case.
Sample Size Calculation:
The sample size for the study was determined using the Open-Epi, Version 3, an open-source
software tool. This calculation was based on the premise that 78.1% of patients with a
cervical angle greater than 95 degrees experience preterm labor. To ensure a confidence level
of 95% and a margin of error of 5%, it was necessary to include at least 263 patients in the
study. The confidence limits were set at 5%, and the design effect was established at 1. The
formula used for this calculation was: n = [DEFFNp(1-p)]/ [(d²/Z²1-α/2(N-1) +p*(1-p)].
Statistical analysis Statistical analysis was done by SPSS v26 (IBM Inc., Chicago, IL, USA).
Quantitative variables were presented as mean and standard deviation (SD). Qualitative
variables were presented as frequency and percentage (%). Correlation between various
variables was done using Pearson coefficient. The diagnostic performance was assessed using
ROC curve analysis, with the AUC serving as a predictor of sPTB.
