MorbiMortality Amelioration in Preeclamptic Primiparas Study. MoMA Pre Prim Study

Not Applicable

Completed

• Conditions: Preeclampsia; Pregnancy; Primiparity; Hypertension; Intrauterine Growth Retardation
• Interventions: Other: Transmission of sFlt-1 results to the investigator; Other: No transmission of the sFlt-1 results to the investigator

• Registration Number: NCT00763672
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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).

Study Timeline

• Study First Submitted: 2008-09-30
• Study First Submitted QC: 2008-09-30
• Study First Posted: 2008-10-01
• Study Start: 2008-11
• Primary Completion: 2011-05
• Study Completion: 2011-06
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-26
• Last Update Posted: 2013-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1040

Inclusion Criteria

• Pregnant womenAge ≥ 18 years
• Followed in our center before the 28th week of gestation
• Under social security coverage
• Signed informed consent

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Exclusion Criteria

• Age < 18 years
• Followed in our center after the 28th week of gestation
• No social security coverage
• Refusal to be included

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Transmission of sFlt-1 results to the investigator	sFlt-1 status known
B	No transmission of the sFlt-1 results to the investigator	sFlt-1 status unknown

Primary Outcome Measures

Name	Time	Method
Reduction in the maternal and fetal morbimortality score	During the pregnancy and the 3 first month of the child

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Gynecology Obstetrics and Reproductive Medicine, Hôpital Tenon, AP-HP, UPMC; 🇫🇷 Paris, France