Clinical trial NCT05245279: Placental Perfusion in the Entire Placenta and With Sonobiopsy by Ultrasound
Official title: Correlation Between the Placental Perfusion Measured in the Entire Placenta and With Sonobiopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Placenta Diseases
Keywords: 3-dimensional ultrasound
ultrasound
placenta
Investigation of placenta in-vivo
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective cohort study was conducted among normal pregnant women recruited at 11 to 40 gestational weeks. Placental vascularization was evaluated using the 3-DPD-indices (vascularization-index (VI); flow-index (FI); vascularization-flow-index (VFI)) with the application of the sphere-technique or scanned from the entire placenta
Primary purpose: DIAGNOSTIC

Brief summary: In this study is tested the validity of placental vascular indices obtained from placenta ultrasonographic sphere biopsy and entire placenta investigation.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maternal characteristics (BMI)
timeFrame: through study completion, 2 years
measure: Neonatal outcome 1; based on gestational age
timeFrame: during first day of life
measure: Neonatal outcome 2, based on maturation of neonates
timeFrame: during first day of life
measure: Neonatal outcome 3, (birth weight of newborns)
timeFrame: during first day of life
measure: Neonatal outcome 4; Apgar score
timeFrame: during first day of life
measure: Neonatal outcome 5, (umbilical cord pH)
timeFrame: during first day of life
measure: Neonatal outcome 6; delivery complication
timeFrame: during first day of life
measure: Neonatal outcome 7, necessary of intensive care unit
timeFrame: during first week of life
Secondary outcomes:
measure: 2D ultrasound investigaiotn of gestation (fetal biometry, placentation)
timeFrame: during prenatal care till the labour
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: Universitiy of Szeged
Study officials:
affiliation: ALBERT SZENT-GYÖRGYI CLINICAL CENTER. REGIONAL SCIENTIFIC AND RESEARCH COMMITTEE FOR HUMAN BIOLOGICAL SCIENCE.
name: Tibor Wittman, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.