MorbiMortality Amelioration in Preeclamptic Primiparas Study. MoMA Pre Prim Study (MOMA)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Hypertension; Intrauterine Growth Retardation; Preeclampsia; Pregnancy; Primiparity

Treatments: Other: Transmission of sFlt-1 results to the investigator; Other: No transmission of the sFlt-1 results to the investigator

Study type: Interventional

Funder types: Other

Identifiers

NCT00763672

P051060

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,040 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,040 participants in 2 patient groups

A

Other group

Description:

sFlt-1 status known

Treatment:

Other: Transmission of sFlt-1 results to the investigator

B

Other group

Description:

sFlt-1 status unknown

Treatment:

Other: No transmission of the sFlt-1 results to the investigator