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
1 other identifier
observational
235
1 country
1
Brief Summary
To assess the role of uterine artery and maternal serum leptin and lipids and their combination in screening for pre-eclampsia and small-for-gestational-age (SGA) fetuses at 20-24 weeks of gestation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2003
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
April 24, 2007
CompletedFirst Posted
Study publicly available on registry
April 25, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedAugust 9, 2013
August 1, 2013
4.1 years
April 24, 2007
August 6, 2013
Conditions
Keywords
Eligibility Criteria
women at increased risk of pre-eclampsia (PE) and intrauterine growth restriction (IUGR)
You may qualify if:
- 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
You may not qualify if:
- Multiple pregnancy
- Complicated pregnancy with a high probability of required fetal extraction before term
- Pregnancy requiring termination
- Unability to understand the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Olympe de Gouges Women Health Centre, Bretonneau University Hospital
Tours, 37044, France
Related Publications (4)
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.
PMID: 17353676BACKGROUNDGuven 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.
PMID: 17111155BACKGROUNDSpencer 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.
PMID: 16493628BACKGROUNDTommaselli 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.
PMID: 15697078BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Franck Perrotin, MD-PhD
Tours University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 24, 2007
First Posted
April 25, 2007
Study Start
May 1, 2003
Primary Completion
June 1, 2007
Study Completion
June 1, 2007
Last Updated
August 9, 2013
Record last verified: 2013-08