Early Placental Insufficiency Screening (BIODOP-T1)
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
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Placental Insufficiency Screening During First Trimester by a Combination of Uterine Artery Dopppler, Maternal PlGF and sFLT-1 in Hight Risk Population|
- Occurrence for Pre-eclampsia or SGA [ Time Frame: During pregnancy and until 72h after delivery ] [ Designated as safety issue: No ]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)
- Early onset pre-eclampsia [ Time Frame: During pregnancy and until 72h after delivery ] [ Designated as safety issue: No ]Early onset pre-eclampsia is defined as pre)eclampsia occurring before 32 completed gestational weeks.
- Severe pre-eclampsia [ Time Frame: During pregnancy and until 72h after delivery ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples Without DNA
|Study Start Date:||May 2007|
|Study Completion Date:||May 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01348711
|Hospital of Blois -Service de Gynécologie-Obstétrique|
|Blois, France, 41016|
|CHRU Hôpital Hôtel-Dieu Département Gynécologie Obstétrique|
|Nantes, France, 44093|
|Hôpital La Milétrie, CHRU Poitiers|
|Poitiers, France, 86021|
|Olympe de Gouges Women Health Centre, Bretonneau University Hospital|
|Tours, France, 37044|
|Study Director:||Franck PERROTIN, MD-PHD||Univsersity Hospital of TOURS|