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Doppler and Biological Second Trimester Placental Insufficiency Screening (ARTULEP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00465634
First Posted: April 25, 2007
Last Update Posted: August 9, 2013
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.
Information provided by:
University Hospital, Tours
  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

Resource links provided by NLM:


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

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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)
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
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 ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Pr Franck Perrotin, CHRU de Tours
ClinicalTrials.gov Identifier: NCT00465634     History of Changes
Other Study ID Numbers: PHRR02-FP/ARTULEP
First Submitted: April 24, 2007
First Posted: April 25, 2007
Last Update Posted: August 9, 2013
Last Verified: August 2013

Keywords provided by University Hospital, Tours:
Screening
uterine artery Doppler
HELLP syndrome
abruption

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Fetal Growth Retardation
Placental Insufficiency
Hypertension, Pregnancy-Induced
Pregnancy Complications
Fetal Diseases
Growth Disorders
Pathologic Processes
Placenta Diseases