Placental Perfusion in the Entire Placenta and With Sonobiopsy by Ultrasound

Sponsor

Szeged University (Other)

Overall Status

Completed

CT.gov ID

NCT05245279

Collaborator

(none)

150

Enrollment

Location

Arms

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Placenta Diseases	Diagnostic Test: 3 dimensional ultrasound investigation Diagnostic Test: 2 dimensional ultrasound investigation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

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 placentaA 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

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Jan 1, 2020

Actual Study Completion Date :

Jan 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Normal placenta-entitle The 3-DPD indices was measured in the entire placenta volume.	Diagnostic Test: 3 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 Test: 2 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.
Experimental: Normal placenta-sonobyopsy The 3-DPD indices was measured at cord insertion in placenta by sonobiopsy	Diagnostic Test: 3 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 Test: 2 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.

Arm

Intervention/Treatment

Experimental: Normal placenta-entitle

The 3-DPD indices was measured in the entire placenta volume.

Diagnostic Test: 3 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 Test: 2 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.

Experimental: Normal placenta-sonobyopsy

The 3-DPD indices was measured at cord insertion in placenta by sonobiopsy

Diagnostic Test: 3 dimensional ultrasound investigation

Diagnostic Test: 2 dimensional ultrasound investigation

Outcome Measures

Primary Outcome Measures

Maternal characteristics (BMI) [through study completion, 2 years]
The 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 age [during first day of life]
The participants were recorded by gestational age et birth
Neonatal outcome 2, based on maturation of neonates [during first day of life]
Neonates were investigatied by maturation ( gestational age before 36+6 week) (prematurity
Neonatal outcome 3, (birth weight of newborns) [during first day of life]
Neonates birth weight calculation (gram)
Neonatal outcome 4; Apgar score [during first day of life]
Neonates poor adaptation status (Apgar score (<7) at 5 minutes)
Neonatal outcome 5, (umbilical cord pH) [during first day of life]
Neonates poor adaptation status (umbilical cord pH <7.2)
Neonatal outcome 6; delivery complication [during first day of life]
Delivery complication ( cesarean section due to fetal distress)
Neonatal outcome 7, necessary of intensive care unit [during first week of life]
Neonates transfer to neonatal intensive care unit (NICU)

Secondary Outcome Measures

2D ultrasound investigaiotn of gestation (fetal biometry, placentation) [during prenatal care till the labour]
Routine 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitiy of Szeged	Szeged		Hungary	6720

Sponsors and Collaborators

Szeged University

Investigators

Study Chair: Tibor Wittman, Professor, ALBERT SZENT-GYÖRGYI CLINICAL CENTER. REGIONAL SCIENTIFIC AND RESEARCH COMMITTEE FOR HUMAN BIOLOGICAL SCIENCE.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:

Andrea Suranyi, Head of placenta study group, Szeged University

ClinicalTrials.gov Identifier:

NCT05245279

Other Study ID Numbers:

120/2015

First Posted:

Feb 17, 2022

Last Update Posted:

Feb 17, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Andrea Suranyi, Head of placenta study group, Szeged University

3-dimensional ultrasound

ultrasound

placenta

Investigation of placenta in-vivo

Additional relevant MeSH terms:

Placenta Diseases

Study Results

No Results Posted as of Feb 17, 2022