- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06347913
Umblical Artery Systolic \Diastolic Ratio and Amniotic Fluid Index in Prediction of Fetal Outcome in Term Pregnancy
April 2, 2024 updated by: Sabrin Alnokrashy Mohamed, Sohag University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
213
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: sabrin A alnokrashy, resident
- Phone Number: 01093395389
- Email: drsabrin444@gmail.com
Study Contact Backup
- Name: Salah r roshdy, professor
Study Locations
-
-
-
Sohag, Egypt
- Sohag University Hospital
-
Contact:
- Magdy M Amin, professor
-
-
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
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
pregnant women term
Description
Inclusion Criteria:
* Age of mother 18-40 years
- Term pregnancy (37w6d -40w)
- Singleton pregnancy
Exclusion Criteria:
*Multiple pregnancy
- Preterm pregnancy before 37w
- Preeclampsia
- IUGR
- Diabetic
- Congenital anomalies of fetus
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 |
Measure Description |
Time Frame |
|---|---|---|
|
Umbilical Artery Systolic/Diastolic Ratio
Time Frame: 6 months
|
Umblical Artery Systolic/Diastolic Ratio
|
6 months
|
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.
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)
April 1, 2024
Primary Completion (Estimated)
August 1, 2024
Study Completion (Estimated)
March 1, 2025
Study Registration Dates
First Submitted
March 11, 2024
First Submitted That Met QC Criteria
April 2, 2024
First Posted (Actual)
April 4, 2024
Study Record Updates
Last Update Posted (Actual)
April 4, 2024
Last Update Submitted That Met QC Criteria
April 2, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-24-03-09MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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