Placenta Diseases Clinical Trial
Official title:
Correlation Between the Placental Perfusion Measured in the Entire Placenta and With Sonobiopsy
Verified date | February 2022 |
Source | Szeged University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this study is tested the validity of placental vascular indices obtained from placenta ultrasonographic sphere biopsy and entire placenta investigation.
Status | Completed |
Enrollment | 150 |
Est. completion date | January 1, 2021 |
Est. primary completion date | January 1, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Hungary | Universitiy of Szeged | Szeged |
Lead Sponsor | Collaborator |
---|---|
Szeged University |
Hungary,
Collins 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. — View Citation
Kozinszky Z, Surányi A, Péics H, Molnár A, Pál 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. — View Citation
Mercé 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. — View Citation
Molnár A, Surányi A, Jakó M, Nyári T, Németh 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. — View Citation
Moran 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. Review. — View Citation
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. — View Citation
Plasencia 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Neonatal outcome 1; based on gestational age | The participants were recorded by gestational age et birth | during first day of life | |
Primary | 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 | |
Primary | Neonatal outcome 3, (birth weight of newborns) | Neonates birth weight calculation (gram) | during first day of life | |
Primary | Neonatal outcome 4; Apgar score | Neonates poor adaptation status (Apgar score (<7) at 5 minutes) | during first day of life | |
Primary | Neonatal outcome 5, (umbilical cord pH) | Neonates poor adaptation status (umbilical cord pH <7.2) | during first day of life | |
Primary | Neonatal outcome 6; delivery complication | Delivery complication ( cesarean section due to fetal distress) | during first day of life | |
Primary | Neonatal outcome 7, necessary of intensive care unit | Neonates transfer to neonatal intensive care unit (NICU) | during first week of life | |
Secondary | 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 |
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