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Cervical Volume and Prediction of Preterm Labor

Role of Cervical Volume and 3 D Power Doppler Indices for Prediction of Preterm Labour

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06190496
Enrollment
300
Registered
2024-01-05
Start date
2024-01-20
Completion date
2026-02-20
Last updated
2024-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Volume, Preterm Labor

Brief 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.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years

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

Design outcomes

Primary

MeasureTime frameDescription
The primary outcome could be the incidence of preterm birth (i.e., births occurring before 37 weeks of gestation) among the study participants.BaselineObstetric 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

Secondary

MeasureTime frameDescription
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.BaselineObstetric 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
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 birthBaselineObstetric 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

Contacts

Primary ContactOmar Mohamed Galal
omargalal2293@gmail.com01011481191
Backup ContactMostafa Hussien Mohamed
mostafahmyd@yahoo.com01005833878

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026