Doppler and Biological Second Trimester Placental Insufficiency Screening - Full Text View

Sponsor:	University Hospital, Tours
Information provided by:	University Hospital, Tours
ClinicalTrials.gov Identifier:	NCT00465634

Purpose

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

Condition
Pre-Eclampsia Fetal Growth Retardation Placental Insufficiency

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Screening for Placental Insufficiency by a Combination of Second Trimester Uterine Artery Doppler and Maternal Serum Leptin and Lipids

Further study details as provided by University Hospital, Tours:

Enrollment:	235
Study Start Date:	May 2003
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

women at increased risk of pre-eclampsia (PE) and intrauterine growth restriction (IUGR)

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465634

Locations

France
Olympe de Gouges Women Health Centre, Bretonneau University Hospital
Tours, France, 37044

Sponsors and Collaborators

University Hospital, Tours

Investigators

Principal Investigator:

Franck Perrotin, MD-PhD

Tours University Hospital

More Information

Publications:

Papageorghiou AT, Leslie K. Uterine artery Doppler in the prediction of adverse pregnancy outcome. Curr Opin Obstet Gynecol. 2007 Apr;19(2):103-109.

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. 2006 Nov 17; [Epub ahead of print]

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.

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.

Responsible Party:	Pr Franck Perrotin, CHRU de Tours
ClinicalTrials.gov Identifier:	NCT00465634 History of Changes
Other Study ID Numbers:	PHRR02-FP/ARTULEP
Study First Received:	April 24, 2007
Last Updated:	February 19, 2010
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Tours:

Screening
uterine artery Doppler
HELLP syndrome
abruption

Additional relevant MeSH terms:

Eclampsia
Fetal Growth Retardation
Placental Insufficiency
Pre-Eclampsia
Hypertension, Pregnancy-Induced

Pregnancy Complications
Fetal Diseases
Growth Disorders
Pathologic Processes
Placenta Diseases

ClinicalTrials.gov processed this record on February 09, 2012