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

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ClinicalTrials.gov Identifier: NCT00763672
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : March 28, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pregnancy Primiparity Hypertension Preeclampsia Intrauterine Growth Retardation Other: Transmission of sFlt-1 results to the investigator Other: No transmission of the sFlt-1 results to the investigator Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1040 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of a Single Second-trimester Plasma sFlt-1 and/or Urinary PlGF Assay on Maternofetal Morbidity/Mortality
Study Start Date : November 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
A
sFlt-1 status known
Other: Transmission of sFlt-1 results to the investigator
Transmission of sFlt-1 results by the laboratory to the investigator
Other Name: Transmission of sFlt-1

B
sFlt-1 status unknown
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.
Other Name: No transmission of the sFlt-1




Primary Outcome Measures :
  1. Reduction in the maternal and fetal morbimortality score [ Time Frame: During the pregnancy and the 3 first month of the child ]

Secondary Outcome Measures :
  1. Child status [ Time Frame: at 3 months post-delivery ]
  2. Length of hospital stay during pregnancy and post-partum periods [ Time Frame: during pregnancy and post-partum periods ]
  3. Predictive value for vascula-renal disease of urinary PlGF as compared with plasmatic sFlt-1. [ Time Frame: between 25 and 28 weeks of gestation ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763672


Locations
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France
Department of Gynecology Obstetrics and Reproductive Medicine, Hôpital Tenon, AP-HP, UPMC
Paris, France, 75020
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Nadia BERKANE, MD Assistance Publique - Hôpitaux de Paris
Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00763672    
Other Study ID Numbers: P051060
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: March 28, 2013
Last Verified: March 2013
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Preeclampsia
Hypertension
Intra uterine growth retardation
Antiangiogenic factor
Prevention
Additional relevant MeSH terms:
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Pre-Eclampsia
Fetal Growth Retardation
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications
Fetal Diseases
Growth Disorders
Pathologic Processes