Early Placental Insufficiency Screening
- Conditions
- Pre-eclampsia
- Registration Number
- NCT01348711
- Lead Sponsor
- University Hospital, Tours
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 226
- 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
- Multiple pregnancy
- Pregnancy requiring termination
- Unability to understand the study
- Thrombophilia
- treatment with heparin
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence for Pre-eclampsia or SGA During pregnancy and until 72h after delivery 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)
- Secondary Outcome Measures
Name Time Method Early onset pre-eclampsia During pregnancy and until 72h after delivery Early onset pre-eclampsia is defined as pre)eclampsia occurring before 32 completed gestational weeks.
Severe pre-eclampsia During pregnancy and until 72h after delivery 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.
Trial Locations
- Locations (4)
Hospital of Blois -Service de Gyn茅cologie-Obst茅trique
馃嚝馃嚪Blois, France
CHRU H么pital H么tel-Dieu D茅partement Gyn茅cologie Obst茅trique
馃嚝馃嚪Nantes, France
H么pital La Mil茅trie, CHRU Poitiers
馃嚝馃嚪Poitiers, France
Olympe de Gouges Women Health Centre, Bretonneau University Hospital
馃嚝馃嚪Tours, France