Doppler and Biological Second Trimester Placental Insufficiency Screening

Completed

• Conditions: Pre-Eclampsia; Fetal Growth Retardation; Placental Insufficiency

• Registration Number: NCT00465634
• Lead Sponsor: 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

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.

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2007-04-24
• Study First Submitted QC: 2007-04-24
• Study First Posted: 2007-04-25
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 235

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Olympe de Gouges Women Health Centre, Bretonneau University Hospital; 🇫🇷 Tours, France