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Doppler and Biological Second Trimester Placental Insufficiency Screening

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00465634
Acronym
ARTULEP
Enrollment
235
Registered
2007-04-25
Start date
2003-05-31
Completion date
2007-06-30
Last updated
2013-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Growth Retardation, Placental Insufficiency, Pre-Eclampsia

Keywords

Screening, uterine artery Doppler, HELLP syndrome, abruption

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

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.

Interventions

None listed

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026