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Completed

NCT Number: NCT00763672

MorbiMortality Amelioration in Preeclamptic Primiparas Study. MoMA Pre Prim Study

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.

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Key information

Conditions

Pregnancy Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Retardation Growth Disorders Hypertension Hypertension, Pregnancy-Induced Intrauterine Growth Retardation Pathologic Processes Pathological Conditions, Signs and Symptoms Pre-Eclampsia Preeclampsia Pregnancy Complications Primiparity Urogenital Diseases Vascular Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gynecology Obstetrics and Reproductive Medicine, Hôpital Tenon, AP-HP, UPMC

Paris, 75020, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transmission of sFlt-1 results to the investigator

Other

Transmission of sFlt-1 results by the laboratory to the investigator

Other names: Transmission of sFlt-1

No transmission of the sFlt-1 results to the investigator

Other

The laboratory do not transmit the sFlt-1 results to the investigator before the end of the study.

Other names: No transmission of the sFlt-1

Primary outcomes

  1. Reduction in the maternal and fetal morbimortality score

    Time frame: During the pregnancy and the 3 first month of the child

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: MOMA

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 1, 2008
Registry last updated
Mar 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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