Cervical Volume and Prediction of Preterm Labor

Preterm Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06190496
• Other study ID #: Cervical volume preterm labor
• Status: Not yet recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Labor

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