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Preterm PregnancyNCT06403059

Cervical Length and Uterocervical Angle as Predictors of Spontaneous Preterm Birth

An observational study of Preterm Pregnancy, run by Beni-Suef University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Preterm Pregnancy
What is being tested?
Cervical Length and Uterocervical Angle
How many people
263 participants
Where
1 siteEgypt
Study dates
15 Oct 2023to 30 Apr 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: 28 to 32 weeks

Who may be able to join

  • pregnant 28 to 32 weeks

Who cannot join

  • additional signs of preterm labour in the mother
  • foetus, polyhydramnios,
  • multiple pregnancies,
  • a previous cervix operation,

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Beni-suef university Hospital

    Banī Suwayf, 62511

Other trials in Egypt

About this study

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.

Read the 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.

Being tested
Cervical Length, Uterocervical Angle
Keywords
preterm delivery, Cervical Length, Uterocervical Angle
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cervical LengthDiagnostic test

    trans vaginal ultrasound

  • Uterocervical AngleDiagnostic test

    by trans vaginal ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cervical length

    TVS examination

    Measured: 28 and 32 weeks of gestation

  2. uterocervical angle

    TVS examination

    Measured: 28 and 32 weeks of gestation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2024
  2. Study start15 Oct 2023
  3. Primary completion15 Apr 2024
  4. Study completion30 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
263 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06403059
Sponsor's protocol ID
CL in preterm
Status last verified
May 2024
First submitted
3 May 2024
Last updated
7 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Preterm Pregnancy, run by Beni-Suef University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cervical length (time frame: 28 and 32 weeks of gestation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.

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