Placental Perfusion in the Entire Placenta and With Sonobiopsy by Ultrasound

University of Szeged (SZTE)

Status: Completed

Conditions: Placenta Diseases

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05245279

120/2015

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Normal placenta-entitle

Experimental group

Description:

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

Treatment:

Diagnostic Test: 2 dimensional ultrasound investigation

Diagnostic Test: 3 dimensional ultrasound investigation

Normal placenta-sonobyopsy

Experimental group

Description:

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

Treatment:

Diagnostic Test: 2 dimensional ultrasound investigation

Diagnostic Test: 3 dimensional ultrasound investigation