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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06190496
Other study ID # Cervical volume preterm labor
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 20, 2024
Est. completion date February 20, 2026

Study information

Verified date December 2023
Source Assiut University
Contact Omar Mohamed Galal
Phone 01011481191
Email omargalal2293@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary aim of this research is to assess the predictive value of 3D cervical volume and 3D power Doppler indices in predicting pregnancies at risk of preterm labor. Secondary aim: to compare 2D cervical length and 3D cervical length in coronal view for predicting preterm labour.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date February 20, 2026
Est. primary completion date January 20, 2026
Accepts healthy volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: 1. Age : 18-35 years old 2. Singleton pregnancy 3. Gestational age : 18-26 Ws knowing last menstrual period and history of regular mense. Exclusion Criteria: 1. Multiple gestations (e.g., twins, triplets). 2. History of cervical surgery or cervical cerclage. 3. Known uterine anomalies that could affect cervical assessment. 4. Contraindications for transvaginal ultrasound, such as active vaginal bleeding or infection. 5. Severe fetal anomalies or conditions incompatible with life

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcome could be the incidence of preterm birth (i.e., births occurring before 37 weeks of gestation) among the study participants. Obstetric ultrasound:Trans abdominal and trans vaginal ultrasounds will be performed to all of ladies. During the trans vaginal scan, The Pulsatility Index (PI) of the uterine artery and the cervical length will be measured. All ultrasound exams will be performed by a single investigator utilizing GE (voluson S 8) ultrasonography machines with pulsed and color Doppler capabilities (GE Medical Systems, Zipf, Austria).
Cervical length measurements: The distance between the internal and external os will be measured. For the purposes of this study, at least two CL measurements were performed, with the shorter of the two being used in the analysis.
Uterine artery Doppler:. The left and right uterine arteries will be measured using trans vaginal ultrasonography with color flow imaging
Baseline
Secondary 1. Gestational Age at Delivery: Measure the gestational age at which participants in the study give birth. This information can help assess whether ultrasonic assessments correlate with the timing of delivery. Obstetric ultrasound:Trans abdominal and trans vaginal ultrasounds will be performed to all of ladies. During the trans vaginal scan, The Pulsatility Index (PI) of the uterine artery and the cervical length will be measured. All ultrasound exams will be performed by a single investigator utilizing GE (voluson S 8) ultrasonography machines with pulsed and color Doppler capabilities (GE Medical Systems, Zipf, Austria).
Cervical length measurements: The distance between the internal and external os will be measured. For the purposes of this study, at least two CL measurements were performed, with the shorter of the two being used in the analysis.
Uterine artery Doppler:. The left and right uterine arteries will be measured using trans vaginal ultrasonography with color flow imaging
Baseline
Secondary 2. Predictive Parameters: Analyse the individual and combined predictive power of cervical length, vascularity indices, and cervical volume. Determine which of these parameters (or their combinations) show the strongest correlation with preterm birth Obstetric ultrasound:Trans abdominal and trans vaginal ultrasounds will be performed to all of ladies. During the trans vaginal scan, The Pulsatility Index (PI) of the uterine artery and the cervical length will be measured. All ultrasound exams will be performed by a single investigator utilizing GE (voluson S 8) ultrasonography machines with pulsed and color Doppler capabilities (GE Medical Systems, Zipf, Austria).
Cervical length measurements: The distance between the internal and external os will be measured. For the purposes of this study, at least two CL measurements were performed, with the shorter of the two being used in the analysis.
Uterine artery Doppler:. The left and right uterine arteries will be measured using trans vaginal ultrasonography with color flow imaging
Baseline
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