Early Placental Insufficiency Screening (BIODOP-T1)

Regional University Hospital Center (CHRU)

Status: Terminated

Conditions: Pre-eclampsia

Study type: Observational

Funder types: Other

Identifiers

NCT01348711

PHRI/06/FP-BIODOP-T1

Details and patient eligibility

About

To assess the role of uterine artery and maternal serum PlGf and sflt-1 and their combination in screening for pre-eclampsia and small -for-gestational age (SGA) fetuses at 12-14 weeks of gestation

Full 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 12 to 14 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.

A variety of angiogenic proteins have been studied as potential markers for pre-eclampsia. Among these protein Plgf and sflt-1 have respectively demonstrated higher and lower levels in pregnant women who will subsequently develop pre-eclampsia.

Our study is aimed to evaluate the performance of serum Plgf and sflt-1 measurement in association with uterine artery Doppler as a screening for placental insufficiency.

Enrollment: 226 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic hypertension under medication
• Insulin or not insulin dependant preexisting diabetes
• 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
• History of vascular pathology before 50 years in the father
• Obesity (BMI>26)
• Nulliparous after 38 years
• Assisted conception with donor
• Primipaternity after 38 years old or before 20 years old

Exclusion criteria

• Multiple pregnancy
• Pregnancy requiring termination
• Unability to understand the study
• Thrombophilia
• treatment with heparin