Placenta DiseasesNCT05245279
Placental Perfusion in the Entire Placenta and With Sonobiopsy by Ultrasound
A study testing 3 dimensional ultrasound investigation and 2 dimensional ultrasound investigation in people with Placenta Diseases, run by Szeged University at 1 site in Hungary.
Trial summary
In this study is tested the validity of placental vascular indices obtained from placenta ultrasonographic sphere biopsy and entire placenta investigation. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Placenta Diseases
- What is being tested?
- 3 dimensional ultrasound investigation and 2 dimensional ultrasound investigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jan 2018to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- single pregnancy
- healthy pregnant women
- no anatomical alteration of fetus
- no genetical abnormality of fetus
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Placenta Diseases
- Being tested
- 3 dimensional ultrasound investigation, 2 dimensional ultrasound investigation
- Keywords
- 3-dimensional ultrasound, ultrasound, placenta, Investigation of placenta in-vivo
- Medical subject headings
- Placenta Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 dimensional ultrasound investigationDiagnostic 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.
2 dimensional ultrasound investigationDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Normal placenta-entitle | Experimental | The 3-DPD indices was measured in the entire placenta volume. Receives: 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 Receives: Diagnostic Test: 3 dimensional ultrasound investigation; Diagnostic Test: 2 dimensional ultrasound investigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: through study completion, 2 years
Neonatal outcome 1; based on gestational age
The participants were recorded by gestational age et birth
Measured: 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
Measured: during first day of life
Neonatal outcome 3, (birth weight of newborns)
Neonates birth weight calculation (gram)
Measured: during first day of life
Neonatal outcome 4; Apgar score
Neonates poor adaptation status (Apgar score (<7) at 5 minutes)
Measured: during first day of life
Neonatal outcome 5, (umbilical cord pH)
Neonates poor adaptation status (umbilical cord pH <7.2)
Measured: during first day of life
Neonatal outcome 6; delivery complication
Delivery complication ( cesarean section due to fetal distress)
Measured: during first day of life
Neonatal outcome 7, necessary of intensive care unit
Neonates transfer to neonatal intensive care unit (NICU)
Measured: during first week of life
Secondary outcomes (1)
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)
Measured: during prenatal care till the labour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start1 Jan 2018
- Primary completion1 Jan 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Placenta DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Suranyi, Szeged University
- Investigators
- Tibor Wittman, Professor, Study chair, ALBERT SZENT-GYÖRGYI CLINICAL CENTER. REGIONAL SCIENTIFIC AND RESEARCH COMMITTEE FOR HUMAN BIOLOGICAL SCIENCE.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245279
- Sponsor's protocol ID
- 120/2015
- Status last verified
- Feb 2022
- First submitted
- 1 Dec 2021
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 21324404Molnar 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.
PubMed 28651459Kozinszky 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.
PubMed 25959054Collins 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.
PubMed 23219036Moran 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.
PubMed 21656781Plasencia 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.
PubMed 21701132Merce 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.
PubMed 15188796
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between the Placental Perfusion Measured in the Entire Placenta and With Sonobiopsy
- ClinicalTrials.gov ID
- NCT05245279
- Acronym / sponsor ID
- 120/2015
- Conditions
- Placenta Diseases
- Keywords
- 3-dimensional ultrasound, ultrasound, placenta, Investigation of placenta in-vivo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Normal placenta-entitle | Experimental | Diagnostic Test: 3 dimensional ultrasound investigation, Diagnostic Test: 2 dimensional ultrasound investigationThe 3-DPD indices was measured in the entire placenta volume. |
| Normal placenta-sonobyopsy | Experimental | Diagnostic Test: 3 dimensional ultrasound investigation, Diagnostic Test: 2 dimensional ultrasound investigationThe 3-DPD indices was measured at cord insertion in placenta by sonobiopsy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- single pregnancy
- healthy pregnant women
- no anatomical alteration of fetus
- no genetical abnormality of fetus
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 dimensional ultrasound investigationImages 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 | Normal placenta-entitle, Normal placenta-sonobyopsy |
| 2 dimensional ultrasound investigationThe 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. | Diagnostic test | Normal placenta-entitle, Normal placenta-sonobyopsy |
Primary outcome
Maternal characteristics (BMI)
Time frame: 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).
Neonatal outcome 1; based on gestational age
Time frame: during first day of life
The participants were recorded by gestational age et birth
Neonatal outcome 2, based on maturation of neonates
Time frame: during first day of life
Neonates were investigatied by maturation ( gestational age before 36+6 week) (prematurity
Neonatal outcome 3, (birth weight of newborns)
Time frame: during first day of life
Neonates birth weight calculation (gram)
Neonatal outcome 4; Apgar score
Time frame: during first day of life
Neonates poor adaptation status (Apgar score (<7) at 5 minutes)
Neonatal outcome 5, (umbilical cord pH)
Time frame: during first day of life
Neonates poor adaptation status (umbilical cord pH <7.2)
Neonatal outcome 6; delivery complication
Time frame: during first day of life
Delivery complication ( cesarean section due to fetal distress)
Neonatal outcome 7, necessary of intensive care unit
Time frame: during first week of life
Neonates transfer to neonatal intensive care unit (NICU)
1 secondary outcome
2D ultrasound investigaiotn of gestation (fetal biometry, placentation)
Time frame: during prenatal care till the labour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Background: PubMed 21324404Odibo 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.
- Background: PubMed 28651459Molnar 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.
- Background: PubMed 25959054Kozinszky 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.
- Background: PubMed 23219036Collins 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.
- Background: PubMed 21656781Moran 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.
- Background: PubMed 21701132Plasencia 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.
- Background: PubMed 15188796Merce 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.
- Matijevic R, Kurjak A. The assessment of placental blood vessels by three-dimensional power Doppler ultrasoundLink provided by the sponsor.
- 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 outcomesLink provided by the sponsor.
- 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 ultrasonographyLink provided by the sponsor.
- Evaluation of placental vascularization by three-dimensional ultrasound examination in second and third trimester of pregnancies complicated by chronic hypertension, gestational hypertension or pre-eclampsiaLink provided by the sponsor.
- 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 GestationLink provided by the sponsor.
- 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 PreeclampsiaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tibor Wittman, Professor study chair
ALBERT SZENT-GYÖRGYI CLINICAL CENTER. REGIONAL SCIENTIFIC AND RESEARCH COMMITTEE FOR HUMAN BIOLOGICAL SCIENCE.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 dimensional ultrasound investigation and 2 dimensional ultrasound investigation in people with Placenta Diseases, run by Szeged University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal characteristics (BMI) (time frame: through study completion, 2 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05245279, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.