Cervical Volume and Prediction of Preterm Labor

Not yet recruiting

• Conditions: Preterm Labor; Cervical Volume

• Registration Number: NCT06190496
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-18
• Study First Submitted QC: 2023-12-18
• Last Update Submitted: 2023-12-18
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05
• Study Start: 2024-01-20
• Primary Completion: 2026-01-20
• Study Completion: 2026-02-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome could be the incidence of preterm birth (i.e., births occurring before 37 weeks of gestation) among the study participants.	Baseline	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

Secondary Outcome Measures

Name	Time	Method
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.	Baseline	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
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	Baseline	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