NCT00763672

MorbiMortality Amelioration in Preeclamptic Primiparas Study. MoMA Pre Prim Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,040 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Pregnancy
• Primiparity
• Hypertension
• Preeclampsia
• Intrauterine Growth Retardation

Interventions

Type	Name	Description
OTHER	Transmission of sFlt-1 results to the investigator	Transmission of sFlt-1 results by the laboratory to the investigator
OTHER	No 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.

Timeline

• Start date: 2008-11-01
• Primary completion: 2011-05-01
• Completion: 2011-06-01
• First posted: 2008-10-01
• Last updated: 2013-03-28

Locations

1 site across 1 country: France