- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05245279
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
Status
Avslutad
Betingelser
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
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Szeged, Ungern, 6720
- Universitiy of Szeged
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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 |
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Experimentell: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Maternal characteristics (BMI)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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2D ultrasound investigaiotn of gestation (fetal biometry, placentation)
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
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
- 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.
Användbara länkar
- 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
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
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Studerar en amerikansk FDA-reglerad produktprodukt
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produkt tillverkad i och exporterad från U.S.A.
Nej
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Kliniska prövningar på 3 dimensional ultrasound investigation
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