- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02854501
Second Trimester Maternal Serum Homocysteine Levels and Uterine Artery Doppler for Prediction of Preeclampsia and Placentation Disorders
Second Trimester Maternal Serum Homocysteine Levels and Uterine Artery Doppler for Prediction of Preeclampsia and Poor Placentation Disorders
Studieoversikt
Status
Forhold
Detaljert beskrivelse
These participants had uterine artery Doppler investigations, as part of a routine scan between the 18th and the 22nd week of pregnancy. The investigators were blinded to the results of the biochemistry results.
All samples of the tHcy measurement were collected between 15 and 19 weeks of gestational age, as calculated from the last menstrual period or from early ultrasound dates (when the menstrual dates differed from the specified gestation). The plasma tHcy concentrations were measured by means of a fluorescence polarization immunoassay (9).
Uterine artery flow velocity waveforms were obtained using an SD 800 Doppler system (Philips Medical Systems, Gland, Switzerland) with a 3.5/5-MHz linear array probe. The high-pass filter was set at 100 Hz. One operator performed the measurements. The use of mean resistance index (RI) cutoff points with bilateral and unilateral notches has already been shown to improve the efficacy of uterine artery Doppler screening using qualitative assessment (10). A screen-positive or abnormal result was defined as bilateral notches and a mean RI >0.55 (50th centile), unilateral notches and a mean RI >0.65 (80th centile), and absence of notches and a mean RI >0.7 (95th centile) (11). Women with these abnormal results were offered growth scans, amniotic fluid volume assessment, and umbilical artery Doppler every 4 weeks until 36 weeks in view of the recognized increased risk of isolated IUGR (12), unless there were other clinical indications, which necessitated closer surveillance
Studietype
Registrering (Faktiske)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Spontaneous pregnancies without history of previous risk factors for preeclampsia
Exclusion Criteria:
- multiple pregnancy, non-intact renal function, and hypertension before 20 weeks of gestation, diabetes mellitus and/or chronic diseases, women taking folic acid supplementations, women using antifolate drugs, and maternal age more than 40 years
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
---|
Uncomplicated pregnancies
|
Preeclampsia
|
Isolated IUGR
|
Any complication
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
development of placentation disorders
Tidsramme: 28-40 weeks gestational age
|
28-40 weeks gestational age
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Ahmed Maged, Kasr Alainy medical school
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 153 (CPEIC)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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