Early Placental Insufficiency Screening

University Hospital, Tours226 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

226

Conditions

Pre-eclampsia

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Hospital of Blois -Service de Gynécologie-Obstétrique

Blois, France

CHRU Hôpital Hôtel-Dieu Département Gynécologie Obstétrique

Nantes, France

Hôpital La Milétrie, CHRU Poitiers

Poitiers, France

Olympe de Gouges Women Health Centre, Bretonneau University Hospital

Tours, France

Outcomes

Primary Outcomes

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)

Time frame: During pregnancy and until 72h after delivery

Secondary Outcomes

Early onset pre-eclampsia

Early onset pre-eclampsia is defined as pre)eclampsia occurring before 32 completed gestational weeks.

Time frame: 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.

Time frame: During pregnancy and until 72h after delivery

Data from ClinicalTrials.gov

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