MorbiMortality Amelioration in Preeclamptic Primiparas Study. MoMA Pre Prim Study

Study Overview
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Brief Summary
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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
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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).

Official Title
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Impact of a Single Second-trimester Plasma sFlt-1 and/or Urinary PlGF Assay on Maternofetal Morbidity/Mortality

Conditions
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Pregnancy, Primiparity, Hypertension, Preeclampsia, Intrauterine Growth Retardation

Intervention / Treatment
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* Other: Transmission of sFlt-1 results to the investigator
* Other: No transmission of the sFlt-1 results to the investigator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>sFlt-1 status known | Other: Transmission of sFlt-1 results to the investigator<br>* Transmission of sFlt-1 results by the laboratory to the investigator<br>* Other names: Transmission of sFlt-1;|
| Other: B<br>sFlt-1 status unknown | Other: No transmission of the sFlt-1 results to the investigator<br>* The laboratory do not transmit the sFlt-1 results to the investigator before the end of the study.<br>* Other names: No transmission of the sFlt-1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the maternal and fetal morbimortality score |  | During the pregnancy and the 3 first month of the child | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preeclampsia, Hypertension, Intra uterine growth retardation, Antiangiogenic factor, Prevention