Skip to main content
OpenTrials
Completed

NCT Number: NCT00465634

Doppler and Biological Second Trimester Placental Insufficiency Screening

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

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

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

Acronym: ARTULEP

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Apr 25, 2007
Registry last updated
Aug 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.