Doppler in Normal PregnancyNCT06761794
Normogram of Umbilical Artery and Fetal Middle Cerebral Artery Doppler Indices in Upper Egyptian Women
An observational study of Doppler in Normal Pregnancy, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Doppler in Normal Pregnancy
- How many people
- 520 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- Child, Adult, Older adult
Study population: Pregnant women with gestational age 15-40 wk, singleton fetus with no anomalies, free of medical and obstetric complications.
Who may be able to join
- 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.
Who cannot join
- Multiple pregnancy
- Fetal anomalies.
- Associated medical disorders.
- Obstetric complications.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Doppler in Normal Pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
pulsatility index of umbilical artery.
Measured: Through study completion, an average of 1 year
Resistive index of umbilical artery
Measured: Through study completion, an average of 1 year
pulsatility index of fetal middle cerebral artery.
Measured: Through study completion, an average of 1 year
Resistive index of fetal middle cerebral artery
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
settle cerebroplacental ratio local reference range.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Doppler in Normal PregnancyStudies 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
- Cross-sectional
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Kamel Morsi Bakhit, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761794
- Sponsor's protocol ID
- Doppler indices in normal preg
- Status last verified
- Dec 2024
- First submitted
- 22 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 15746695Mari 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.
PubMed 15789353Ebbing 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.
PubMed 17721916Maulik 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.
PubMed 21353090Tarzamni 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.
PubMed 19111026Dubiel 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.
PubMed 11169324
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normogram of Umbilical Artery and Fetal Middle Cerebral Artery Doppler Indices in Upper Egyptian Women
- ClinicalTrials.gov ID
- NCT06761794
- Acronym / sponsor ID
- Doppler indices in normal preg
- Conditions
- Doppler in Normal Pregnancy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 7 Jan 2025 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women with gestational age 15-40 wk, singleton fetus with no anomalies, free of medical and obstetric complications.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Multiple pregnancy
- Fetal anomalies.
- Associated medical disorders.
- Obstetric complications.
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
pulsatility index of umbilical artery.
Time frame: Through study completion, an average of 1 year
Resistive index of umbilical artery
Time frame: 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
Resistive index of fetal middle cerebral artery
Time frame: Through study completion, an average of 1 year
1 secondary outcome
settle cerebroplacental ratio local reference range.
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Results publication: PubMed 15746695Acharya 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.
- Results publication: PubMed 15789353Mari 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.
- Results publication: PubMed 17721916Ebbing 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.
- Results publication: PubMed 21353090Maulik 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.
- Results publication: PubMed 19111026Tarzamni 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.
- Results publication: PubMed 11169324Dubiel 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.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Doppler in Normal Pregnancy, 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 7 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salma Kamel Bakhit, Graduate (0201094242196, salma0122858@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pulsatility index of umbilical artery. (time frame: Through study completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06761794, which also lists 6 linked publications.
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 7 Jan 2025.