Placental Perfusion in the Entire Placenta and With Sonobiopsy by Ultrasound

Not Applicable

Completed

• Conditions: Placenta Diseases
• Interventions: Diagnostic Test: 3 dimensional ultrasound investigation; Diagnostic Test: 2 dimensional ultrasound investigation

• Registration Number: NCT05245279
• Lead Sponsor: Szeged University

Brief Summary

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 Timeline

• Study Start: 2018-01-01
• Primary Completion: 2020-01-01
• Study Completion: 2021-01-01
• Study First Submitted: 2021-12-01
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-16
• Last Update Submitted: 2022-02-16
• Study First Posted: 2022-02-17
• Last Update Posted: 2022-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal placenta-entitle	3 dimensional ultrasound investigation	The 3-DPD indices was measured in the entire placenta volume.
Normal placenta-entitle	2 dimensional ultrasound investigation	The 3-DPD indices was measured in the entire placenta volume.
Normal placenta-sonobyopsy	3 dimensional ultrasound investigation	The 3-DPD indices was measured at cord insertion in placenta by sonobiopsy
Normal placenta-sonobyopsy	2 dimensional ultrasound investigation	The 3-DPD indices was measured at cord insertion in placenta by sonobiopsy

Primary Outcome Measures

Name	Time	Method
Neonatal outcome 6; delivery complication	during first day of life	Delivery complication ( cesarean section due to fetal distress)
Neonatal outcome 3, (birth weight of newborns)	during first day of life	Neonates birth weight calculation (gram)
Neonatal outcome 7, necessary of intensive care unit	during first week of life	Neonates transfer to neonatal intensive care unit (NICU)
Maternal characteristics (BMI)	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	during first day of life	The participants were recorded by gestational age et birth
Neonatal outcome 4; Apgar score	during first day of life	Neonates poor adaptation status (Apgar score (\<7) at 5 minutes)
Neonatal outcome 5, (umbilical cord pH)	during first day of life	Neonates poor adaptation status (umbilical cord pH \<7.2)
Neonatal outcome 2, based on maturation of neonates	during first day of life	Neonates were investigatied by maturation ( gestational age before 36+6 week) (prematurity

Secondary Outcome Measures

Name	Time	Method
2D ultrasound investigaiotn of gestation (fetal biometry, placentation)	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)

Trial Locations

Locations (1)

Universitiy of Szeged; 🇭🇺 Szeged, Hungary