NCT06347913

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
213

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2024

Completed
21 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

March 11, 2024

Last Update Submit

April 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Umbilical Artery Systolic/Diastolic Ratio

    Umblical Artery Systolic/Diastolic Ratio

    6 months

Interventions

ultrasoundRADIATION

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

Also known as: umblical artery doppler in term pregnancy

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

pregnant women term

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 1553186BACKGROUND

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Central Study Contacts

sabrin A alnokrashy, resident

CONTACT

Salah r roshdy, professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident at obstetric and gynacology department at sohag university hospial

Study Record Dates

First Submitted

March 11, 2024

First Posted

April 4, 2024

Study Start

April 1, 2024

Primary Completion

August 1, 2024

Study Completion

March 1, 2025

Last Updated

April 4, 2024

Record last verified: 2024-04

Locations