Doppler and Biological Second Trimester Placental Insufficiency Screening (ARTULEP)
Screening for Placental Insufficiency by a Combination of Second Trimester Uterine Artery Doppler and Maternal Serum Leptin and Lipids
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Pre-eclampsia (PE) and intrauterine growth restriction (IUGR) are known as major factors in perinatal morbidity and mortality. Routine antenatal care is focused on the detection of women at increased risk to apply this population a program of careful monitoring and appropriate intervention.
Uterine artery Doppler during anomaly scan at 20 to 24 weeks in selected women at increased risk, has proved to be accurate to detect those who will develop PE or IUGR during the second half of pregnancy. Studies have reported detection rate of 50-70% for a 5% false positive rate in women developing early pre-eclampsia.
A variety of proteins and hormones have been studied as potential markers for pre-eclampsia. Among these protein serum placental leptin has demonstrated higher levels in pregnant women who will subsequently develop pre-eclampsia. However, screening performance of leptin detection in early pregnancy has never been assessed.
Our study is aimed to evaluate the performance of serum leptin measurement in association with uterine artery Doppler as a screening too for placental insufficiency.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Tours, Frankrike, 37044
- Olympe de Gouges Women Health Centre, Bretonneau University Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Chronic hypertension under medication
- Diabetes
- Thrombophilia
- Previous history of pre-eclampsia
- Previous history of unexplained stillbirth
- Previous history of placental abruption
- Previous history of SGA (< 10th centile)
- History of pre-eclampsia or chronic hypertension before 45 years in the mother or a sister
- Obesity (BMI>30)
- Nulliparous after 40 years
- Assisted conception with donor
Exclusion Criteria:
- Multiple pregnancy
- Complicated pregnancy with a high probability of required fetal extraction before term
- Pregnancy requiring termination
- Unability to understand the study
Studieplan
Hur är studien utformad?
Designdetaljer
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Franck Perrotin, MD-PhD, Tours University Hospital
Publikationer och användbara länkar
Allmänna publikationer
- Papageorghiou AT, Leslie K. Uterine artery Doppler in the prediction of adverse pregnancy outcome. Curr Opin Obstet Gynecol. 2007 Apr;19(2):103-9. doi: 10.1097/GCO.0b013e32809bd964.
- Guven MA, Ertas IE, Kilinc M, Coskun A, Ekerbicer H. Combining mid-trimester maternal plasma homocysteine with uterine artery doppler velocimetry: is it useful? Arch Gynecol Obstet. 2007 Jun;275(6):439-43. doi: 10.1007/s00404-006-0281-5. Epub 2006 Nov 17.
- Spencer K, Yu CK, Savvidou M, Papageorghiou AT, Nicolaides KH. Prediction of pre-eclampsia by uterine artery Doppler ultrasonography and maternal serum pregnancy-associated plasma protein-A, free beta-human chorionic gonadotropin, activin A and inhibin A at 22 + 0 to 24 + 6 weeks' gestation. Ultrasound Obstet Gynecol. 2006 Jun;27(6):658-63. doi: 10.1002/uog.2676.
- Tommaselli GA, Pighetti M, Nasti A, D'Elia A, Guida M, Di Carlo C, Bifulco G, Nappi C. Serum leptin levels and uterine Doppler flow velocimetry at 20 weeks' gestation as markers for the development of pre-eclampsia. Gynecol Endocrinol. 2004 Sep;19(3):160-5. doi: 10.1080/09513590400007267.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PHRR02-FP/ARTULEP
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