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- Klinische proef NCT02473991
Correlation Between Placental Thickness in the Second and Third Trimester and Fetal Weight
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
The investigator will make certain that the appropriate informed consent process is in place to ensure that potential research subjects, or their authorized representatives, are fully informed about the nature and objectives of the study, the potential risk and benefits of study participation, and their right as research subjects.
All laboratory specimens, evaluation forms, reports, video recordings, and other records that leave the site will not include unique personal data to maintain subject confidentiality.
All patients provided an informed written consent after they were fully instructed about the investigation.The study was approved by ethical committee of Ain Shams University.
All recruited women were observed at the 1st trimester screening at antenatal clinic and assessed for baseline demographic and obstetric data including age, parity, body mass index (BMI) and past medical events. Smoking, alcohol and drug use were also determined.
At second and third trimester (15-20 and 30-34 weeks of gestation respectively), the maternal weight, weight gain, BMI, BMI gain and data of ultrasound examination were recorded. At the time of delivery after assessment of maternal weight as mentioned above, the birth weight (in grams), fetal sex, and mode of delivery were taken.
All pregnant women underwent ultrasound evaluation of placental thickness at the time of second trimester (15-20 weeks of gestation) as well as third trimester (30-34 weeks of gestation).
All sonographic examinations were performed trans-abdominal using a Medison X4 ultrasound machine Trans abdominal4.0 megahertz (MHz) probe at The Special Care Center for Fetus Unit at Ain Shams University Maternity Hospital.
The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion as described by Hoddick et al
Each evaluation was performed by one of two experienced sonographers of our hospital with minimum inter- and intra-observer variability.
After delivery, the placenta was weighed in grams as previously described by Azpurua et al.
Fetal weight (primary objective) and neonatal status and morbidity including baby Apgar scores, fetal distress or fetal death and admission to the neonatal intensive care unit were also determined. All the examinations and data recording were performed by two senior resident physicians.(secondary objective)
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Elabbasia
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Cairo, Elabbasia, Egypte
- Ain Shams Faculty of Medicine
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- patient Aged between 18 and 45 years.
- singleton viable pregnancy.
- non scared uterus.
Exclusion Criteria:
- systemic illness (DM,Hypertension, renal disease, liver disease, sickle cell disease)
- known congenital fetal anomalies.
- multiple pregnancy.
- intra uterine fetal death.
- anatomical defect of pregnant uterus
- abnormally located placenta or placental anomalies
- morbid obesity
- missing records
- unwilling to incorporate in the study.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Fetal Weight (Fetal Weight at Birth)
Tijdsspanne: 9 months
|
Fetal weight (fetal weight at birth) (in grams)
|
9 months
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Placental Thickness in Second Trimester
Tijdsspanne: 15-20 weeks of gestation
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placental thickness measured in millimeter
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15-20 weeks of gestation
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Placental Thickness at 3rd Trimester
Tijdsspanne: 30-34 weeks of pregnancy
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30-34 weeks of pregnancy
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie directeur: AHMED MEKLED, Professor, ain shams University
- Studie directeur: HAYTHAM SABAA, Lecturer, ain shams University
Publicaties en nuttige links
Algemene publicaties
- Azpurua H, Funai EF, Coraluzzi LM, Doherty LF, Sasson IE, Kliman M, Kliman HJ. Determination of placental weight using two-dimensional sonography and volumetric mathematic modeling. Am J Perinatol. 2010 Feb;27(2):151-5. doi: 10.1055/s-0029-1234034. Epub 2009 Aug 3.
- Hoddick WK, Mahony BS, Callen PW, Filly RA. Placental thickness. J Ultrasound Med. 1985 Sep;4(9):479-82. doi: 10.7863/jum.1985.4.9.479.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Master degree in Obs & gyn
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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