Early Placental Insufficiency Screening

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Placental Insufficiency Screening During First Trimester by a Combination of Uterine Artery Dopppler, Maternal PlGF and sFLT-1 in Hight Risk Population

Conditions
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Pre-eclampsia

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence for Pre-eclampsia or SGA | Pre-eclampsia is defined as hypertension (systolic blood pressure 140mmHg or greater or a diastolic blood pressure 90mmHg or greater on at least 2 occasions 4 hour or 1 week apart) accompanied by proteinuria (more or equal to 0.5g/day or 1 dipstick of ++ or more). SGA is defined as birth weight below the 10th centile for gestational age at birth according to the national birthweight distribution of the french population (INSERM) | During pregnancy and until 72h after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early onset pre-eclampsia | Early onset pre-eclampsia is defined as pre)eclampsia occurring before 32 completed gestational weeks. | During pregnancy and until 72h after delivery | 
| Severe pre-eclampsia | Severe pre-eclampsia is defined as systolic blood pressure of 160mmHg or greater or a diastolic blood pressure of 110mmHg or greater and/or proteinuria greater than 5g in 24 hour collection or occurrence of abruption, eclampsia (seizures during pre-eclampsia), HELLP syndrome (hemolysis, elevated enzyme liver, low platelets), renal insufficiency, fetal demise or birth weight below the 5th centile for gestational age. | During pregnancy and until 72h after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-eclampsia