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Umblical Artery Doppler in Term PregnancyNCT06347913

Umblical Artery Systolic \Diastolic Ratio and Amniotic Fluid Index in Prediction of Fetal Outcome in Term Pregnancy

An observational study of Umblical Artery Doppler in Term Pregnancy, run by Sohag University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Antepartum fetal surveillance is the cornerstone of management in pregnancy. [1] It is done primarily to reduce the incidence of adverse fetal outcomes. It minimizes morbidity by optimizing the timing of delivery. Fetus at risk of chronic hypoxia is identified and unnecessary interventions are avoided. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
What is being tested?
ultrasound
Type of treatment
Surgery or procedure
How many people
213 participants
Where
1 siteEgypt
Study dates
Apr 2024to Mar 2025
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 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: pregnant women term

Who may be able to join

  • * Age of mother 18-40 years
  • Term pregnancy (37w6d -40w)
  • Singleton pregnancy

Who cannot join

  • *Multiple pregnancy
  • Preterm pregnancy before 37w
  • Preeclampsia
  • IUGR
  • Diabetic
  • Congenital anomalies of fetus

Trial locations and contacts

1 site in 1 country.

sabrin A alnokrashy, resident contact

01093395389

drsabrin444@gmail.com

Salah r roshdy, professor contact

Egypt1 site
  • Sohag university Hospital

    Sohag

    Magdy M Amin, professor

Other trials in Egypt

About this study

Official title: Umblical Artery Systolic \Diastolic Ratio and Amniotic Fluid Index in Prediction of Fetal

Antepartum fetal surveillance is the cornerstone of management in pregnancy. [1] It is done primarily to reduce the incidence of adverse fetal outcomes. It minimizes morbidity by optimizing the timing of delivery. Fetus at risk of chronic hypoxia is identified and unnecessary interventions are avoided. However, fetal surveillance acts as a diagnostic modality to detect the influence of maternal, placental, and fetal factors on the fetus. The timely detection of morbid changes in the fetal status followed by adequate interventions to avoid death or disability is one of the most important objectives of prenatal care. [2] Tests now commonly done for antepartum fetal surveillance are nonstress test (NST), amniotic fluid index (AFI), biophysical profile, Doppler study of umbilical artery (UA), and middle cerebral artery (MCA).[3 6] However, AFI and UA Doppler velocimetry both form an essential part of the antenatal surveillance in the assessment of fetal well being. UA Doppler is a powerful tool that allows the obstetrician to follow a sequence of fetal hemodynamic events that happen in response to placental insufficiency. [7] However, several studies have reported higher sensitivities and specificities for UA Doppler ratio for prediction of fetal prognosis. [3 6] Amniotic fluid is the product of complex and dynamic fetal and placental physiologic processes. Disruption of the fine balance may result in overproduction or underproduction of fluid. Liquor adequacy often reflects the fetal status. Oligohydramnios is associated with increased perinatal loss. Furthermore, other studies indicate that UA velocimetry is a predictor of adverse outcomes in pregnancies complicated by oligohydramnios. [8,9] Thus, arterial Doppler velocimetry measurement may be useful in predicting adverse pregnancy outcomes adjunct to other antenatal surveillance tests, especially the AFI. Therefore, the present study will be done to evaluate the comparative assessment of UA ratio and AFI in predicting adverse perinatal outcomes.

Being tested
ultrasound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ultrasoundRadiation

    Also called umblical artery doppler in term pregnancy

    Umbilical Artery Systolic/Diastolic Ratio and Amniotic Fluid Index in Prediction of Fetal Outcome in Term Pregnancies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Umbilical Artery Systolic/Diastolic Ratio

    Umblical Artery Systolic/Diastolic Ratio

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2024
  2. Study startApr 2024 (estimated)
  3. Primary completionAug 2024 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

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
213 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06347913
Sponsor's protocol ID
Soh-Med-24-03-09MS
Status last verified
Apr 2024
First submitted
11 Mar 2024
Last updated
4 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Arduini D, Rizzo G, Romanini C. Changes of pulsatility index from fetal vessels preceding the onset of late decelerations in growth-retarded fetuses. Obstet Gynecol. 1992 Apr;79(4):605-10.

    PubMed 1553186

Questions about this trial

What is this clinical trial studying?

An observational study of Umblical Artery Doppler in Term Pregnancy, run by Sohag University at 1 site in Egypt.

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 6 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 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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 sabrin A alnokrashy, resident (01093395389, drsabrin444@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Umbilical Artery Systolic/Diastolic Ratio (time frame: 6 months). 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 NCT06347913, which also lists 1 linked publication.

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 4 Apr 2024.

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Clinical Trial NCT06347913 | AzTrials