- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06403059
Cervical Length and Uterocervical Angle as Predictors of Spontaneous Preterm Birth
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Banī Suwayf, Egypt, 62511
- Beni-Suef University hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- pregnant 28 to 32 weeks
Exclusion Criteria:
- additional signs of preterm labour in the mother
- foetus, polyhydramnios,
- multiple pregnancies,
- a previous cervix operation,
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cervical length
Time Frame: 28 and 32 weeks of gestation
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TVS examination
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28 and 32 weeks of gestation
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uterocervical angle
Time Frame: 28 and 32 weeks of gestation
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TVS examination
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28 and 32 weeks of gestation
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CL in preterm
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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