Preterm LaborNCT06190496
Cervical Volume and Prediction of Preterm Labor
An observational study of Preterm Labor and Cervical Volume, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Preterm Labor, Cervical Volume
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2024to 20 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Adult
Study population: Pregnant women in the second trimester knowing last menstrual period and history of regular menses at Women's Health Hospital Assuit University
Who may be able to join
- Age : 18-35 years old
- Singleton pregnancy
- Gestational age : 18-26 Ws knowing last menstrual period and history of regular mense.
Who cannot join
- Multiple gestations (e.g., twins, triplets).
- History of cervical surgery or cervical cerclage.
- Known uterine anomalies that could affect cervical assessment.
- Contraindications for transvaginal ultrasound, such as active vaginal bleeding or infection.
- Severe fetal anomalies or conditions incompatible with life
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Preterm Labor, Cervical Volume
- Medical subject headings
- Obstetric Labor, Premature
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Secondary outcomes (2)
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
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start20 Jan 2024 (estimated)
- Primary completion20 Jan 2026 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Mohamed Galal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06190496
- Sponsor's protocol ID
- Cervical volume preterm labor
- Status last verified
- Dec 2023
- First submitted
- 18 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Cervical Volume and 3 D Power Doppler Indices for Prediction of Preterm Labour
- ClinicalTrials.gov ID
- NCT06190496
- Acronym / sponsor ID
- Cervical volume preterm labor
- Conditions
- Preterm Labor, Cervical Volume
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jan 2024 (estimated)
- Primary completion
- 20 Jan 2026 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant women in the second trimester knowing last menstrual period and history of regular menses at Women's Health Hospital Assuit University
Key inclusion criteria (3 listed)
- Age : 18-35 years old
- Singleton pregnancy
- Gestational age : 18-26 Ws knowing last menstrual period and history of regular mense.
Key exclusion criteria (5 listed)
- Multiple gestations (e.g., twins, triplets).
- History of cervical surgery or cervical cerclage.
- Known uterine anomalies that could affect cervical assessment.
- Contraindications for transvaginal ultrasound, such as active vaginal bleeding or infection.
- Severe fetal anomalies or conditions incompatible with life
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcome could be the incidence of preterm birth (i.e., births occurring before 37 weeks of gestation) among the study participants.
Time frame: 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 secondary outcomes
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.
Time frame: 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
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Labor and Cervical Volume, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omar Mohamed Galal (01011481191, omargalal2293@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome could be the incidence of preterm birth (i.e., births occurring before 37 weeks of gestation) among the study participants. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.