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Placental Perfusion in the Entire Placenta and With Sonobiopsy by Ultrasound
16 februari 2022 bijgewerkt door: Andrea Suranyi, Szeged University
Correlation Between the Placental Perfusion Measured in the Entire Placenta and With Sonobiopsy
In this study is tested the validity of placental vascular indices obtained from placenta ultrasonographic sphere biopsy and entire placenta investigation.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
150
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Szeged, Hongarije, 6720
- Universitiy of Szeged
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 45 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Normal placenta-entitle
The 3-DPD indices was measured in the entire placenta volume.
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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.
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.
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Experimenteel: Normal placenta-sonobyopsy
The 3-DPD indices was measured at cord insertion in placenta by sonobiopsy
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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.
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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Maternal characteristics (BMI)
Tijdsspanne: through study completion, 2 years
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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).
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through study completion, 2 years
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Neonatal outcome 1; based on gestational age
Tijdsspanne: during first day of life
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The participants were recorded by gestational age et birth
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during first day of life
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Neonatal outcome 2, based on maturation of neonates
Tijdsspanne: during first day of life
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Neonates were investigatied by maturation ( gestational age before 36+6 week) (prematurity
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during first day of life
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Neonatal outcome 3, (birth weight of newborns)
Tijdsspanne: during first day of life
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Neonates birth weight calculation (gram)
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during first day of life
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Neonatal outcome 4; Apgar score
Tijdsspanne: during first day of life
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Neonates poor adaptation status (Apgar score (<7) at 5 minutes)
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during first day of life
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Neonatal outcome 5, (umbilical cord pH)
Tijdsspanne: during first day of life
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Neonates poor adaptation status (umbilical cord pH <7.2)
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during first day of life
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Neonatal outcome 6; delivery complication
Tijdsspanne: during first day of life
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Delivery complication ( cesarean section due to fetal distress)
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during first day of life
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Neonatal outcome 7, necessary of intensive care unit
Tijdsspanne: during first week of life
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Neonates transfer to neonatal intensive care unit (NICU)
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during first week of life
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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2D ultrasound investigaiotn of gestation (fetal biometry, placentation)
Tijdsspanne: during prenatal care till the labour
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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)
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during prenatal care till the labour
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie stoel: Tibor Wittman, Professor, ALBERT SZENT-GYÖRGYI CLINICAL CENTER. REGIONAL SCIENTIFIC AND RESEARCH COMMITTEE FOR HUMAN BIOLOGICAL SCIENCE.
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Nuttige links
- First trimester placental and myometrial blood perfusion measured by 3D power Doppler in normal and unfavourable outcome pregnancies
- Matijevic R, Kurjak A. The assessment of placental blood vessels by three-dimensional power Doppler ultrasound
- 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
- Pairleitner H, Steiner H, Hasenoehrl G, Staudach A. Three-dimensional power Doppler sonography: imaging and quantifying blood flow and vascularization
- 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
- 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
- Surányi A, Kozinszky Z, Molnár A, Németh G. Placental volume relative to fetal weight estimated by sonography in diabetic pregnancies
- 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
- 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
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 januari 2018
Primaire voltooiing (Werkelijk)
1 januari 2020
Studie voltooiing (Werkelijk)
1 januari 2021
Studieregistratiedata
Eerst ingediend
1 december 2021
Eerst ingediend dat voldeed aan de QC-criteria
16 februari 2022
Eerst geplaatst (Werkelijk)
17 februari 2022
Updates van studierecords
Laatste update geplaatst (Werkelijk)
17 februari 2022
Laatste update ingediend die voldeed aan QC-criteria
16 februari 2022
Laatst geverifieerd
1 februari 2022
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 120/2015
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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