Doppler and Biological Second Trimester Placental Insufficiency Screening
NCT ID: NCT00465634
Last Updated: 2013-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
235 participants
OBSERVATIONAL
2003-05-31
2007-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* Complicated pregnancy with a high probability of required fetal extraction before term
* Pregnancy requiring termination
* Unability to understand the study
18 Years
45 Years
FEMALE
No
Sponsors
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University Hospital, Tours
OTHER
Responsible Party
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CHRU de Tours
Principal Investigators
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Franck Perrotin, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
Tours University Hospital
Locations
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Olympe de Gouges Women Health Centre, Bretonneau University Hospital
Tours, , France
Countries
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References
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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.
Other Identifiers
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PHRR02-FP/ARTULEP
Identifier Type: -
Identifier Source: org_study_id