Placental Perfusion in the Entire Placenta and With Sonobiopsy by Ultrasound

NCT05245279 | Completed

• 1 other identifier: 120/2015
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Placenta Diseases

Keywords

3-dimensional ultrasound; ultrasound; placenta; Investigation of placenta in-vivo

Outcome Measures

Primary Outcomes (8)

• Maternal characteristics (BMI)

  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

  The participants were recorded by gestational age et birth

  during first day of life

• Neonatal outcome 2, based on maturation of neonates

  Neonates were investigatied by maturation ( gestational age before 36+6 week) (prematurity

  during first day of life

• Neonatal outcome 3, (birth weight of newborns)

  Neonates birth weight calculation (gram)

  during first day of life

• Neonatal outcome 4; Apgar score

  Neonates poor adaptation status (Apgar score (\<7) at 5 minutes)

  during first day of life

• Neonatal outcome 5, (umbilical cord pH)

  Neonates poor adaptation status (umbilical cord pH \<7.2)

  during first day of life

• Neonatal outcome 6; delivery complication

  Delivery complication ( cesarean section due to fetal distress)

  during first day of life

• Neonatal outcome 7, necessary of intensive care unit

  Neonates transfer to neonatal intensive care unit (NICU)

  during first week of life

Secondary Outcomes (1)

• 2D ultrasound investigaiotn of gestation (fetal biometry, placentation)

  during prenatal care till the labour

Study Arms (2)

Normal placenta-entitle

EXPERIMENTAL

The 3-DPD indices was measured in the entire placenta volume.

Diagnostic Test: 3 dimensional ultrasound investigation; Diagnostic Test: 2 dimensional ultrasound investigation

Normal placenta-sonobyopsy

EXPERIMENTAL

The 3-DPD indices was measured at cord insertion in placenta by sonobiopsy

Diagnostic Test: 3 dimensional ultrasound investigation; Diagnostic Test: 2 dimensional ultrasound investigation

Interventions

3 dimensional ultrasound investigation DIAGNOSTIC_TEST

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.

Normal placenta-entitle; Normal placenta-sonobyopsy

2 dimensional ultrasound investigation DIAGNOSTIC_TEST

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.

Normal placenta-entitle; Normal placenta-sonobyopsy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: The investigator studed pregnat women to analise the placental funciton in-vivo.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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)
• single pregnancy
• healthy pregnant women
• no anatomical alteration of fetus
• no genetical abnormality of fetus

Sponsors & Collaborators

• Szeged University: lead

Study Sites (1)

Universitiy of Szeged

Szeged, 6720, Hungary

Location

Related Publications (7)

• 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.

  PMID: 21324404 BACKGROUND

• 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.

  PMID: 28651459 BACKGROUND

• 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.

  PMID: 25959054 BACKGROUND

• 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.

  PMID: 23219036 BACKGROUND

• 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.

  PMID: 21656781 BACKGROUND

• 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.

  PMID: 21701132 BACKGROUND

• 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.

  PMID: 15188796 BACKGROUND

Related Links

• 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
• 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
• 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

MeSH Terms

Conditions

Placenta Diseases

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Tibor Wittman, Professor

  ALBERT SZENT-GYÖRGYI CLINICAL CENTER. REGIONAL SCIENTIFIC AND RESEARCH COMMITTEE FOR HUMAN BIOLOGICAL SCIENCE.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of placenta study group

Model Details: 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

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: February 17, 2022
• Study Start: January 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2021
• Last Updated: February 17, 2022

Record last verified: 2022-02

Locations

HU (1)