Doppler and Biological Second Trimester Placental Insufficiency Screening

Pre-Eclampsia Clinical Trial

— ARTULEP  

Official title:

Screening for Placental Insufficiency by a Combination of Second Trimester Uterine Artery Doppler and Maternal Serum Leptin and Lipids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00465634
• Other study ID #: PHRR02-FP/ARTULEP
• Status: Completed
• Phase: N/A
• First received: April 24, 2007
• Last updated: August 6, 2013
• Start date: May 2003
• Est. completion date: June 2007

Study information

• Verified date: August 2013
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Placental Insufficiency
• Pre-Eclampsia

Locations

Country	Name	City	State
France	Olympe de Gouges Women Health Centre, Bretonneau University Hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

References & Publications (4)

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. Epub 2006 Nov 17. — View Citation

Papageorghiou AT, Leslie K. Uterine artery Doppler in the prediction of adverse pregnancy outcome. Curr Opin Obstet Gynecol. 2007 Apr;19(2):103-9. Review. — View Citation

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. — View Citation

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. — View Citation