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Placental Perfusion in the Entire Placenta and With Sonobiopsy by Ultrasound

Correlation Between the Placental Perfusion Measured in the Entire Placenta and With Sonobiopsy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05245279
Enrollment
150
Registered
2022-02-17
Start date
2018-01-01
Completion date
2021-01-01
Last updated
2022-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placenta Diseases

Keywords

3-dimensional ultrasound, ultrasound, placenta, Investigation of placenta in-vivo

Brief summary

In this study is tested the validity of placental vascular indices obtained from placenta ultrasonographic sphere biopsy and entire placenta investigation.

Detailed description

Although, to this date, there have been a number of human placental studies that concerned the evaluation of placental 3 dimensional power Doppler vascularization with the use of VOCAL technique, but there was no one in which placental vasculature has been compared between the sonobiopsy and whole placental volume.

Interventions

DIAGNOSTIC_TEST3 dimensional ultrasound investigation

Images that contributed to the determination of placental volume and 3-DPD indices were obtained at the time of visit. All 3-D scans ultrasound measurements were performed by a Voluson 730 Expert ultrasound machine equipped with a multifrequency probe (2-5 MHz) to acquire images. Each sample was examined using 3-D rendering mode, in which the colour and gray value information was processed and combined to supply 3-D image. For laterally located placentas, the investigator positioned the transducer on a slight lateral inclination to obtain proper images. Power Doppler window was placed over the placenta to map the vascular tree from basal to chorionic plates. The 3-D static volume box was placed over the entire placenta volume. The sweep angle was set at maximum 70°. Each image was recovered from the disk in succession for processing. During gestation, the investigator recorded one sample from each patient.

DIAGNOSTIC_TEST2 dimensional ultrasound investigation

The two-dimensional (2-D) transabdominal conventional study provided data about fetal position, biometry, body movements and fetal heart rate as well as placental localization. The factorial default setting 'Obstetrics' was applied in 2-D mode.

Sponsors

Szeged University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

A prospective cohort study was conducted among normal pregnant women recruited at 11 to 40 gestational weeks. Placental vascularization was evaluated using the 3-DPD-indices (vascularization-index (VI); flow-index (FI); vascularization-flow-index (VFI)) with the application of the sphere-technique or scanned from the entire placenta

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Exclusion criteria

* multiple pregnancy, * abnormal (\> 3mm) nuchal translucency from 11+0 to 13+6 weeks of gestation, * the fetal or neonatal structural or chromosomal anomaly, * inadequate localization of the placenta (placenta praevia), * self-reported drugs, alcohol, caffeine or nicotine abuse, * exposed to circulatory medication (oxerutins, calcium dobesilate) * or not signing the consent form. * If the mother suffer from er systemic disease (e.g. diabetes, autoimmune disease, vasculitis, haemophilia, thrombophilia, HIV infection, etc) Inclusion clriteria: * single pregnancy * healthy pregnant women * no anatomical alteration of fetus * no genetical abnormality of fetus

Design outcomes

Primary

MeasureTime frameDescription
Neonatal outcome 4; Apgar scoreduring first day of lifeNeonates poor adaptation status (Apgar score (\<7) at 5 minutes)
Neonatal outcome 6; delivery complicationduring first day of lifeDelivery complication ( cesarean section due to fetal distress)
Neonatal outcome 7, necessary of intensive care unitduring first week of lifeNeonates transfer to neonatal intensive care unit (NICU)
Neonatal outcome 5, (umbilical cord pH)during first day of lifeNeonates poor adaptation status (umbilical cord pH \<7.2)
Maternal characteristics (BMI)through study completion, 2 yearsThe pre-pregnancy body mass index (BMI) registered at the initial visit during prenatal care was calculated as the body weight (kg) per height (m2).
Neonatal outcome 1; based on gestational ageduring first day of lifeThe participants were recorded by gestational age et birth
Neonatal outcome 2, based on maturation of neonatesduring first day of lifeNeonates were investigatied by maturation ( gestational age before 36+6 week) (prematurity
Neonatal outcome 3, (birth weight of newborns)during first day of lifeNeonates birth weight calculation (gram)

Secondary

MeasureTime frameDescription
2D ultrasound investigaiotn of gestation (fetal biometry, placentation)during prenatal care till the labourRoutine ultrasound examination, based on Guideline of Hungarian Obstetrics and gynecologists (fetal biometry: biparietal diameter, head circumference, abdominal circumference, femur length; investigation of the placenta, place of placentation, Grannum staging)

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026