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Completed

NCT Number: NCT06224946

IMPACT OF THE BIOLOGICAL RATIO ON MEDICAL DECISION MAKING IN WOMEN SUSPECTED OF PREECLAMPSIA

Previous studies demonstrated that Placental Growth Factor (PIGF) and Vascular Endothelial Growth Factor (VEGF) produced by trophoblast cells decreases during Preeclampsia, whereas soluble fms-like tyrosine kinase-1 (sFlt-1), an antiangiogenic factor, increases. The ratio sFlt-1/PlGF has a higher positive predictive value than the isolated measurement. A ratio under 38 exclude risk of imminent preeclampsia and allows to outpatient follow-up with a negative predictive value of 99.3%. A ratio equal or higher than 38 permits to direct high-risk patients towards hospitalization with a positive predictive value of 36.7% of preeclampsia at 4 weeks. These findings suggest that the ratio can be used to select more appropriately women needing hospitalization for suspected preeclampsia.

This is a single-center prospective and observational study conducted from the 1rst of October 2019 to the 27th of January 2021, including pregnant women suspected of preeclampsia, above 24 weeks of gestation. Values were measured using the Elecsys sFlt-1/PlGF immunoassay ratio. The aim of the study is to observe the clinical decision regarding hospitalization, intensive patient monitoring, corticosteroid administration, and labor induction before and after knowing the ratio value

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Chu Saint-Etienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • pregnant patients over 24 weeks of amenorrhea
  • aged 18 and over
  • with suspicion of preeclampsia defined by the appearance of pregnancy-induced hypertension (≥ 140 in systolic and/or 90 mmHg in diastolic pressure over 2 measurements at 4 hours intervals) OR proteinuria (≥ 0.3 g per 24 hours).
  • who systematically gave oral consent after submitting the information sheet

Exclusion criteria

  • pregnant women with both hypertension and proteinuria because they already have a confirmed diagnosis of preeclampsia.
  • receiving antihypertensive treatment before pregnancy
  • or refusing to participate in the study The sFlt-1/PlGF ratio was measured only when clinically indicated as per the investigator's judgment.

Treatment and study plan

soluble fms-like tyrosine kinase (sFlt-1) / placental growth factor (PlGF) ratio

Diagnostic Test

the soluble fms-like tyrosine kinase (sFlt-1) / placental growth factor (PlGF) ratio for pre-eclampsia diagnostic

Primary outcomes

  1. The soluble fms-like tyrosine kinase (sFlt-1) / placental growth factor (PlGF) ratio

    Time frame: day 1

    Evaluate the impact of the soluble fms-like tyrosine kinase (sFlt-1) / placental growth factor (PlGF) ratio on medical decision-making in women with suspected preeclampsia in routine medical care.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

IMPACT OF THE SOLUBLE LIKE TYROSINE KINASE/PLACENTAL GROWTH FACTOR RATIO ON MEDICAL DECISION-MAKING AND ON MATERNAL AND NEONATAL OUTCOMES IN WOMEN SUSPECTED OF PREECLAMPSIA

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 25, 2024
Registry last updated
Jan 25, 2024

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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