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Completed

NCT Number: NCT05245279

Placental Perfusion in the Entire Placenta and With Sonobiopsy by Ultrasound

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

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Key information

Conditions

Placenta Diseases Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universitiy of Szeged

Szeged, 6720, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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).

  2. Neonatal outcome 1; based on gestational age

    Time frame: during first day of life

    The participants were recorded by gestational age et birth

  3. 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

  4. Neonatal outcome 3, (birth weight of newborns)

    Time frame: during first day of life

    Neonates birth weight calculation (gram)

  5. Neonatal outcome 4; Apgar score

    Time frame: during first day of life

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

  6. Neonatal outcome 5, (umbilical cord pH)

    Time frame: during first day of life

    Neonates poor adaptation status (umbilical cord pH <7.2)

  7. Neonatal outcome 6; delivery complication

    Time frame: during first day of life

    Delivery complication ( cesarean section due to fetal distress)

  8. Neonatal outcome 7, necessary of intensive care unit

    Time frame: during first week of life

    Neonates transfer to neonatal intensive care unit (NICU)

Secondary outcomes

  1. 2D ultrasound investigaiotn of gestation (fetal biometry, placentation)

    Time frame: during prenatal care till the labour

    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)

Sponsors and collaborators

Lead sponsor

Szeged University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Feb 17, 2022
Registry last updated
Feb 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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