Placental Perfusion in the Entire Placenta and With Sonobiopsy by Ultrasound

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

Detailed Description
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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.

Official Title
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Correlation Between the Placental Perfusion Measured in the Entire Placenta and With Sonobiopsy

Conditions
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Placenta Diseases

Intervention / Treatment
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* Diagnostic Test: 3 dimensional ultrasound investigation
* Diagnostic Test: 2 dimensional ultrasound investigation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3-dimensional ultrasound, ultrasound, placenta, Investigation of placenta in-vivo