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Doppler and Biological Second Trimester Placental Insufficiency Screening (ARTULEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00465634
Recruitment Status : Completed
First Posted : April 25, 2007
Last Update Posted : August 9, 2013
Information provided by:
University Hospital, Tours

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

Condition or disease
Pre-Eclampsia Fetal Growth Retardation Placental Insufficiency

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.

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Study Type : Observational
Actual Enrollment : 235 participants
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
Study Start Date : May 2003
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00465634

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Olympe de Gouges Women Health Centre, Bretonneau University Hospital
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Tours
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Principal Investigator: Franck Perrotin, MD-PhD Tours University Hospital
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Responsible Party: Pr Franck Perrotin, CHRU de Tours Identifier: NCT00465634    
Other Study ID Numbers: PHRR02-FP/ARTULEP
First Posted: April 25, 2007    Key Record Dates
Last Update Posted: August 9, 2013
Last Verified: August 2013
Keywords provided by University Hospital, Tours:
uterine artery Doppler
HELLP syndrome
Additional relevant MeSH terms:
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Fetal Growth Retardation
Placental Insufficiency
Hypertension, Pregnancy-Induced
Pregnancy Complications
Fetal Diseases
Growth Disorders
Pathologic Processes
Placenta Diseases