Placental Perfusion in the Entire Placenta and With Sonobiopsy by Ultrasound

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.

Study Overview

• Status: Completed
• Conditions: Placenta Diseases
• Intervention / Treatment: Diagnostic test: 3 dimensional ultrasound investigation; Diagnostic test: 2 dimensional ultrasound 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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Szeged, Hungary, 6720
    • Universitiy of Szeged

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal placenta-entitle; The 3-DPD indices was measured in the entire placenta volume.	Diagnostic test: 3 dimensional ultrasound investigation; 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.; Diagnostic test: 2 dimensional ultrasound investigation; 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.
Experimental: Normal placenta-sonobyopsy; The 3-DPD indices was measured at cord insertion in placenta by sonobiopsy	Diagnostic test: 3 dimensional ultrasound investigation; 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.; Diagnostic test: 2 dimensional ultrasound investigation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
2D ultrasound investigaiotn of gestation (fetal biometry, placentation)	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

Collaborators and Investigators

• Sponsor: Szeged University
• Investigators: Study Chair: Tibor Wittman, Professor, ALBERT SZENT-GYÖRGYI CLINICAL CENTER. REGIONAL SCIENTIFIC AND RESEARCH COMMITTEE FOR HUMAN BIOLOGICAL SCIENCE.

Publications and helpful links

General Publications

• 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.

Helpful Links

• 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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: ultrasound; 3-dimensional ultrasound; placenta; Investigation of placenta in-vivo
• Additional Relevant MeSH Terms: Pregnancy Complications; Placenta Diseases
• Other Study ID Numbers: 120/2015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No