Cervical Volume and Prediction of Preterm Labor

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Preterm Labor; Cervical Volume

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Omar Mohamed Galal; Phone Number: 01011481191; Email: omargalal2293@gmail.com
• Study Contact Backup: Name: Mostafa Hussien Mohamed; Phone Number: 01005833878; Email: mostafahmyd@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women in the second trimester knowing last menstrual period and history of regular menses at Women's Health Hospital Assuit University

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2024
• Primary Completion (Estimated): January 20, 2026
• Study Completion (Estimated): February 20, 2026

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: December 18, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth; Obstetric Labor, Premature
• Other Study ID Numbers: Cervical volume preterm labor

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No