Hypertension, Intrauterine Growth Retardation, Preeclampsia, Pregnancy, Primiparity
Conditions
Keywords
Preeclampsia, Hypertension, Intra uterine growth retardation, Antiangiogenic factor, Prevention
Brief summary
The purpose of this study is to determine whether close monitoring of patients with a high sFlt1 plasma level between 25 and 28 weeks of gestation (i.e. at high risk of subsequent preeclampsia) improves maternal and fetal outcomes. The investigator hypothesize that 1/ early screening for preeclampsia by plasmatic sFlt1 will reduce maternal and fetal mortality and morbidity and 2/ a simple urinary PlGF screening will be effective.
Detailed description
We will measure plasmatic sFlt-1 level between 25 and 28 weeks of gestation and flow velocity of uterine arteries by Doppler (22 - 26 weeks of gestation) in primipara. Patients will be stratified according to the results of the uterine artery Doppler measurement, and then randomized in two groups A and B. In group A, sFlt-1 concentration will be communicated to the obstetrician (+ or -): the threshold of abnormally high plasmatic concentration of sFlt-1 is 957 ng/mL. In patients with a high plasmatic concentration of sFlt-1 (+), the pregnancy will be closely monitored including repeated clinical, biological, and ultrasound examinations. Patients with sFlt-1 plasmatic concentration below 957 ng/mL (-) will be routinely followed-up.In group B, the result of sFlt-1 measurement will not be communicated and the pregnancy will be routinely monitored.Abnormal Doppler recordings in either group will result in a close monitoring as per our usual local practice. Urinary PlGF (expressed as a ratio PlGF/creatininemia) will also be measured and the results will be analyzed at the end of the study. Beside sFlt-1, we will store the plasmatic samples to measure other biomarkers that could be relevant in the future (no DNA analysis will be done without a new patient consent).
Interventions
OTHERTransmission of sFlt-1 results to the investigator
Transmission of sFlt-1 results by the laboratory to the investigator
OTHERNo transmission of the sFlt-1 results to the investigator
The laboratory do not transmit the sFlt-1 results to the investigator before the end of the study.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant womenAge ≥ 18 years * Followed in our center before the 28th week of gestation * Under social security coverage * Signed informed consent
Exclusion criteria
* Age \< 18 years * Followed in our center after the 28th week of gestation * No social security coverage * Refusal to be included
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the maternal and fetal morbimortality score | During the pregnancy and the 3 first month of the child |
Secondary
| Measure | Time frame |
|---|---|
| Child status | at 3 months post-delivery |
| Length of hospital stay during pregnancy and post-partum periods | during pregnancy and post-partum periods |
| Predictive value for vascula-renal disease of urinary PlGF as compared with plasmatic sFlt-1. | between 25 and 28 weeks of gestation |
Countries
France
Outcome results
None listed