- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05245279
Placental Perfusion in the Entire Placenta and With Sonobiopsy by Ultrasound
16. februar 2022 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
150
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Szeged, Ungarn, 6720
- Universitiy of Szeged
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 45 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Maternal characteristics (BMI)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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2D ultrasound investigaiotn of gestation (fetal biometry, placentation)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Tibor Wittman, Professor, ALBERT SZENT-GYÖRGYI CLINICAL CENTER. REGIONAL SCIENTIFIC AND RESEARCH COMMITTEE FOR HUMAN BIOLOGICAL SCIENCE.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Hjælpsomme 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
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2018
Primær færdiggørelse (Faktiske)
1. januar 2020
Studieafslutning (Faktiske)
1. januar 2021
Datoer for studieregistrering
Først indsendt
1. december 2021
Først indsendt, der opfyldte QC-kriterier
16. februar 2022
Først opslået (Faktiske)
17. februar 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. februar 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. februar 2022
Sidst verificeret
1. februar 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 120/2015
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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