- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07336173
Uterine Artery Doppler Indices and Uterocervical Angle Measurment in Prediction of Preterm Labor
Role of Uterine Artery Doppler Indices and Sonographic Measurement of Uterocervical Angle in Predicting Preterm Labor
The goal of this observational study is to evaluate the role of uterine artery doppler indices and uterocervical angle measurement in prediction of preterm labor .The main question it aims to answer is:
Does combination of both uterine artery doppler indices and uterocervical angle measurement increase sensitivity and specificity for prediction of established preterm labor ? Participants already performing uterine artery doppler as part of their regular antenatal care .measurement of anterior uterocervical angle will be added between 24 to 34 weeks gestation to predict preterm labor in candidates .
Study Overview
Detailed Description
In this study the aim is to evaluate the combined predictive value of both uterine artery doppler and uterocervical angle measurement in a prospective cohort study design to predict preterm labor . The abnormal mid-trimester uterine artery resistance, pulsatility index and diastolic notching measured with Doppler sonography is known to be predictive for preeclampsia and, hence, for iatrogenic Preterm labor. It will be measured via trans abdominal approach.
The measurement of UCA in the second trimester of pregnancy is strongly associated with the occurrence of spontaneous Preterm labor and will be measured via transvaginal approach .
Both measurement will be conducted between 24 to 34 weeks gestational .
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nourhan M Shalaby, Master
- Phone Number: +201060674910
- Email: nourashalaby44@gmail.com
Study Contact Backup
- Name: Ahmed M Fathy, MD
- Phone Number: +2 0122 1485021
Study Locations
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Kafr ash Shaykh, Egypt
- Recruiting
- Kafr Elsheikh University Hospital
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Contact:
- Kafrelshiekh university
- Phone Number: +20 47 310 9590
- Email: Kfs_info@kfs.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient who will give verbal & written will informed consent.
- Pregnant women between 18 and 40 years old of age
- Singleton pregnancy
- Gestational age will be confirmed by first trimester ultrasound scan (<14 weeks).
- Gestational age between 24 and 34 weeks .
- Threatened preterm labor which is defined as:
Presence of at least one uterine contraction every 10 minutes lasting ≥30 seconds . Cervical dilatation ≤3 cm . Cervical effacement <80%.
Exclusion Criteria:
Obstetric:
- Ruptured membranes
- Clinical evidence of Chorioamnionitis.
- Fetal compromise on evaluation.
- Severe obstetric complications (e.g., severe Preeclampsia, Eclampsia).
- Diagnosed intrauterine growth restriction (IUGR).
- Congenital fetal anomalies.
- Multiple pregnancies.
- Prior cervical surgery (e.g., cone biopsy, cerclage).
Non-Obstetric:
- Significant maternal medical disorders (e.g., chronic hypertension, diabetes mellitus, liver dysfunction).
- Severe non-obstetric complications (e.g., acute abdomen).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sensitivity, specificity and accuracy performance of uterine artery Doppler indices and uterocervical angle assed by ultrasound for prediction of preterm labor
Time Frame: From 24 to 34 weeks gestation
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Its hypothesized that: Abnormal uterine artery Doppler indices and an abnormal (acute) uterocervical angle (< 95°) are significant predictors of preterm labor. The combination of these two parameters will enhance the sensitivity and specificity of preterm labor prediction. |
From 24 to 34 weeks gestation
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KFSIRB200-597
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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