- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06761794
Normogram of Umbilical Artery and Fetal Middle Cerebral Artery Doppler Indices in Upper Egyptian Women
January 6, 2025 updated by: Salma Kamel Morsi Bakhit, Assiut University
settle umbilical and fetal middle cerebral arteries Doppler indices( pulsatility index and resistive index) in normal pregnancy to generate a local reference range and calculate cerebroplacental ratio.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
520
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Salma Kamel Bakhit, Graduate
- Phone Number: 0201094242196
- Email: salma0122858@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Pregnant women with gestational age 15-40 wk, singleton fetus with no anomalies, free of medical and obstetric complications.
Description
Inclusion Criteria:
- Singleton pregnancy between 15 and 40 weeks gestational age.
- Sure of her date (well-known LMP or confirmed date by an early ultrasound).
- Normal fetal anatomy.
- No history of medical disorders.
Exclusion Criteria:
- Multiple pregnancy
- Fetal anomalies.
- Associated medical disorders.
- Obstetric complications.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
pulsatility index of umbilical artery.
Time Frame: Through study completion, an average of 1 year
|
Through study completion, an average of 1 year
|
|
Resistive index of umbilical artery
Time Frame: Through study completion, an average of 1 year
|
Through study completion, an average of 1 year
|
|
pulsatility index of fetal middle cerebral artery.
Time Frame: Through study completion, an average of 1 year
|
Through study completion, an average of 1 year
|
|
Resistive index of fetal middle cerebral artery
Time Frame: Through study completion, an average of 1 year
|
Through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
settle cerebroplacental ratio local reference range.
Time Frame: Through study completion, an average of 1 year
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ebbing C, Rasmussen S, Kiserud T. Middle cerebral artery blood flow velocities and pulsatility index and the cerebroplacental pulsatility ratio: longitudinal reference ranges and terms for serial measurements. Ultrasound Obstet Gynecol. 2007 Sep;30(3):287-96. doi: 10.1002/uog.4088.
- Acharya G, Wilsgaard T, Berntsen GK, Maltau JM, Kiserud T. Reference ranges for serial measurements of umbilical artery Doppler indices in the second half of pregnancy. Am J Obstet Gynecol. 2005 Mar;192(3):937-44. doi: 10.1016/j.ajog.2004.09.019.
- Mari G. Middle cerebral artery peak systolic velocity for the diagnosis of fetal anemia: the untold story. Ultrasound Obstet Gynecol. 2005 Apr;25(4):323-30. doi: 10.1002/uog.1882. No abstract available.
- Maulik D, Mundy D, Heitmann E, Maulik D. Umbilical artery Doppler in the assessment of fetal growth restriction. Clin Perinatol. 2011 Mar;38(1):65-82, vi. doi: 10.1016/j.clp.2010.12.004.
- Tarzamni MK, Nezami N, Gatreh-Samani F, Vahedinia S, Tarzamni M. Doppler waveform indices of fetal middle cerebral artery in normal 20 to 40 weeks pregnancies. Arch Iran Med. 2009 Jan;12(1):29-34.
- Dubiel M, Breborowicz GH, Marsal K, Gudmundsson S. Fetal adrenal and middle cerebral artery Doppler velocimetry in high-risk pregnancy. Ultrasound Obstet Gynecol. 2000 Oct;16(5):414-8. doi: 10.1046/j.1469-0705.2000.00278.x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2025
Primary Completion (Estimated)
January 1, 2026
Study Completion (Estimated)
April 1, 2026
Study Registration Dates
First Submitted
December 22, 2024
First Submitted That Met QC Criteria
January 6, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 6, 2025
Last Verified
December 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- Doppler indices in normal preg
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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