Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

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

      • Szeged, Ungarn, 6720
        • Universitiy of Szeged

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
Eksperimentel: Normal placenta-entitle
The 3-DPD indices was measured in the entire placenta volume.
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.
Eksperimentel: Normal placenta-sonobyopsy
The 3-DPD indices was measured at cord insertion in placenta by sonobiopsy
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maternal characteristics (BMI)
Tidsramme: 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).
through study completion, 2 years
Neonatal outcome 1; based on gestational age
Tidsramme: during first day of life
The participants were recorded by gestational age et birth
during first day of life
Neonatal outcome 2, based on maturation of neonates
Tidsramme: during first day of life
Neonates were investigatied by maturation ( gestational age before 36+6 week) (prematurity
during first day of life
Neonatal outcome 3, (birth weight of newborns)
Tidsramme: during first day of life
Neonates birth weight calculation (gram)
during first day of life
Neonatal outcome 4; Apgar score
Tidsramme: during first day of life
Neonates poor adaptation status (Apgar score (<7) at 5 minutes)
during first day of life
Neonatal outcome 5, (umbilical cord pH)
Tidsramme: during first day of life
Neonates poor adaptation status (umbilical cord pH <7.2)
during first day of life
Neonatal outcome 6; delivery complication
Tidsramme: during first day of life
Delivery complication ( cesarean section due to fetal distress)
during first day of life
Neonatal outcome 7, necessary of intensive care unit
Tidsramme: during first week of life
Neonates transfer to neonatal intensive care unit (NICU)
during first week of life

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
2D ultrasound investigaiotn of gestation (fetal biometry, placentation)
Tidsramme: 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)
during prenatal care till the labour

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

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

Hjælpsomme links

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

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner