Clinical trial NCT01348711: Early Placental Insufficiency Screening
Official title: Placental Insufficiency Screening During First Trimester by a Combination of Uterine Artery Dopppler, Maternal PlGF and sFLT-1 in Hight Risk Population
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pre-eclampsia
Keywords: Pre-eclampsia
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2011-05-05
Enrollment: 226
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant between 12 and 14 weeks

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.

Eligibility criteria: 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

Primary outcomes:
measure: Occurrence for Pre-eclampsia or SGA
timeFrame: During pregnancy and until 72h after delivery
Secondary outcomes:
measure: Early onset pre-eclampsia
timeFrame: During pregnancy and until 72h after delivery
measure: Severe pre-eclampsia
timeFrame: During pregnancy and until 72h after delivery
Other outcomes:
Locations:
city: Blois
country: France
facility: Hospital of Blois -Service de Gynécologie-Obstétrique
city: Nantes
country: France
facility: CHRU Hôpital Hôtel-Dieu Département Gynécologie Obstétrique
city: Poitiers
country: France
facility: Hôpital La Milétrie, CHRU Poitiers
city: Tours
country: France
facility: Olympe de Gouges Women Health Centre, Bretonneau University Hospital
Study officials:
affiliation: Univsersity Hospital of TOURS
name: Franck PERROTIN, MD-PHD
role: STUDY_DIRECTOR
References: