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Placental Perfusion in the Entire Placenta and With Sonobiopsy by Ultrasound

Primary Purpose

Placenta Diseases

Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
3 dimensional ultrasound investigation
2 dimensional ultrasound investigation
Sponsored by
Szeged University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Placenta Diseases focused on measuring 3-dimensional ultrasound, ultrasound, placenta, Investigation of placenta in-vivo

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Universitiy of Szeged

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Normal placenta-entitle

Normal placenta-sonobyopsy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

2D ultrasound investigaiotn of gestation (fetal biometry, placentation)
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)

Full Information

First Posted
December 1, 2021
Last Updated
February 16, 2022
Sponsor
Szeged University
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1. Study Identification

Unique Protocol Identification Number
NCT05245279
Brief Title
Placental Perfusion in the Entire Placenta and With Sonobiopsy by Ultrasound
Official Title
Correlation Between the Placental Perfusion Measured in the Entire Placenta and With Sonobiopsy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Szeged University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Diseases
Keywords
3-dimensional ultrasound, ultrasound, placenta, Investigation of placenta in-vivo

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal placenta-entitle
Arm Type
Experimental
Arm Description
The 3-DPD indices was measured in the entire placenta volume.
Arm Title
Normal placenta-sonobyopsy
Arm Type
Experimental
Arm Description
The 3-DPD indices was measured at cord insertion in placenta by sonobiopsy
Intervention Type
Diagnostic Test
Intervention Name(s)
3 dimensional ultrasound investigation
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
2 dimensional ultrasound investigation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maternal characteristics (BMI)
Description
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).
Time Frame
through study completion, 2 years
Title
Neonatal outcome 1; based on gestational age
Description
The participants were recorded by gestational age et birth
Time Frame
during first day of life
Title
Neonatal outcome 2, based on maturation of neonates
Description
Neonates were investigatied by maturation ( gestational age before 36+6 week) (prematurity
Time Frame
during first day of life
Title
Neonatal outcome 3, (birth weight of newborns)
Description
Neonates birth weight calculation (gram)
Time Frame
during first day of life
Title
Neonatal outcome 4; Apgar score
Description
Neonates poor adaptation status (Apgar score (<7) at 5 minutes)
Time Frame
during first day of life
Title
Neonatal outcome 5, (umbilical cord pH)
Description
Neonates poor adaptation status (umbilical cord pH <7.2)
Time Frame
during first day of life
Title
Neonatal outcome 6; delivery complication
Description
Delivery complication ( cesarean section due to fetal distress)
Time Frame
during first day of life
Title
Neonatal outcome 7, necessary of intensive care unit
Description
Neonates transfer to neonatal intensive care unit (NICU)
Time Frame
during first week of life
Secondary Outcome Measure Information:
Title
2D ultrasound investigaiotn of gestation (fetal biometry, placentation)
Description
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)
Time Frame
during prenatal care till the labour

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
The investigator studed pregnat women to analise the placental funciton in-vivo.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tibor Wittman, Professor
Organizational Affiliation
ALBERT SZENT-GYÖRGYI CLINICAL CENTER. REGIONAL SCIENTIFIC AND RESEARCH COMMITTEE FOR HUMAN BIOLOGICAL SCIENCE.
Official's Role
Study Chair
Facility Information:
Facility Name
Universitiy of Szeged
City
Szeged
ZIP/Postal Code
6720
Country
Hungary

12. IPD Sharing Statement

Citations:
PubMed Identifier
21324404
Citation
Odibo AO, Zhong Y, Longtine M, Tuuli M, Odibo L, Cahill AG, Macones GA, Nelson DM. First-trimester serum analytes, biophysical tests and the association with pathological morphometry in the placenta of pregnancies with preeclampsia and fetal growth restriction. Placenta. 2011 Apr;32(4):333-8. doi: 10.1016/j.placenta.2011.01.016. Epub 2011 Feb 13.
Results Reference
background
PubMed Identifier
28651459
Citation
Molnar A, Suranyi A, Jako M, Nyari T, Nemeth G. [Examination of placental three-dimensional power Doppler indices and perinatal outcome in pregnancies complicated by intrauterine growth restriction]. Orv Hetil. 2017 Jul;158(26):1008-1013. doi: 10.1556/650.2017.30784. Hungarian.
Results Reference
background
PubMed Identifier
25959054
Citation
Kozinszky Z, Suranyi A, Peics H, Molnar A, Pal A. Placental Volumetry by 2-D Sonography with a New Mathematical Formula: Prospective Study on the Shell of a Spherical Sector Model. Ultrasound Med Biol. 2015 Aug;41(8):2252-8. doi: 10.1016/j.ultrasmedbio.2015.04.005. Epub 2015 May 7.
Results Reference
background
PubMed Identifier
23219036
Citation
Collins SL, Stevenson GN, Noble JA, Impey L. Rapid calculation of standardized placental volume at 11 to 13 weeks and the prediction of small for gestational age babies. Ultrasound Med Biol. 2013 Feb;39(2):253-60. doi: 10.1016/j.ultrasmedbio.2012.09.003. Epub 2012 Dec 4.
Results Reference
background
PubMed Identifier
21656781
Citation
Moran M, McAuliffe FM. Imaging and assessment of placental function. J Clin Ultrasound. 2011 Sep;39(7):390-8. doi: 10.1002/jcu.20846. Epub 2011 Jun 8.
Results Reference
background
PubMed Identifier
21701132
Citation
Plasencia W, Akolekar R, Dagklis T, Veduta A, Nicolaides KH. Placental volume at 11-13 weeks' gestation in the prediction of birth weight percentile. Fetal Diagn Ther. 2011;30(1):23-8. doi: 10.1159/000324318. Epub 2011 Jun 23.
Results Reference
background
PubMed Identifier
15188796
Citation
Merce LT, Barco MJ, Bau S. Reproducibility of the study of placental vascularization by three-dimensional power Doppler. J Perinat Med. 2004;32(3):228-33. doi: 10.1515/JPM.2004.043.
Results Reference
background
Links:
URL
https://doi.org/10.1515/JPM.2002.004
Description
Matijevic R, Kurjak A. The assessment of placental blood vessels by three-dimensional power Doppler ultrasound
URL
https://doi.org/10.1016/j.placenta.2011.01.010
Description
Odibo AO, Goetzinger KR, Huster KM, Christiansen JK, Odibo L, Tuuli MG. Placental volume and vascular flow assessed by 3D power Doppler and adverse pregnancy outcomes
URL
https://doi.org/10.1016/j.placenta.2009.12.018
Description
Tuuli MG, Houser M, Odibo L, Huster K, Macones GA, Odibo AO. Validation of placental vascular sonobiopsy for obtaining representative placental vascular indices by three-dimensional power Doppler ultrasonography
URL
https://doi.org/10.1016/j.preghy.2017.03.004
Description
Evaluation of placental vascularization by three-dimensional ultrasound examination in second and third trimester of pregnancies complicated by chronic hypertension, gestational hypertension or pre-eclampsia
URL
https://doi.org/10.1055/s-0038-1632369
Description
Demers S, Boutin A, Dembickaja R, Campanero M, Nicolaides K. Factors Associated with Placental Vascularization Measured by 3D Power Doppler Ultrasonographic Sphere Biopsy between 11 and 14 Weeks of Gestation
URL
https://doi.org/10.1055/s-0034-1396686
Description
Demers S, Girard M, Roberge S, Tetu A, Giguere Y, Forest J-C, et al. First-Trimester Placental and Myometrial Blood Perfusion Measured by Three-Dimensional Power Doppler in Preeclampsia

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Placental Perfusion in the Entire Placenta and With Sonobiopsy by Ultrasound

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