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Placental Perfusion in the Entire Placenta and With Sonobiopsy by Ultrasound

16 februari 2022 uppdaterad av: 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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

150

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Szeged, Ungern, 6720
        • Universitiy of Szeged

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 45 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Diagnostisk
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Maternal characteristics (BMI)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: during first day of life
Neonates birth weight calculation (gram)
during first day of life
Neonatal outcome 4; Apgar score
Tidsram: 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)
Tidsram: during first day of life
Neonates poor adaptation status (umbilical cord pH <7.2)
during first day of life
Neonatal outcome 6; delivery complication
Tidsram: 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
Tidsram: during first week of life
Neonates transfer to neonatal intensive care unit (NICU)
during first week of life

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
2D ultrasound investigaiotn of gestation (fetal biometry, placentation)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 januari 2018

Primärt slutförande (Faktisk)

1 januari 2020

Avslutad studie (Faktisk)

1 januari 2021

Studieregistreringsdatum

Först inskickad

1 december 2021

Först inskickad som uppfyllde QC-kriterierna

16 februari 2022

Första postat (Faktisk)

17 februari 2022

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 februari 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 februari 2022

Senast verifierad

1 februari 2022

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 120/2015

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

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Kliniska prövningar på 3 dimensional ultrasound investigation

3
Prenumerera