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Impact of the sFlt-1/PlGF Ratio on Medical Decision-making and on Maternal and Neonatal Outcomes in Women Suspected of Preeclampsia

Impact of the sFlt-1/PlGF Ratio on Medical Decision-making and on Maternal and Neonatal Outcomes in Women Suspected of Preeclampsia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06314555
Enrollment
314
Registered
2024-03-18
Start date
2019-10-01
Completion date
2021-01-27
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia Possible

Keywords

Preeclampsia, Soluble fms-like tyrosine kinase, Placental growth factor, Medical care decision, Hospitalization

Brief summary

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.

Detailed description

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 investigators observed the clinical decision regarding hospitalization, intensive patient monitoring, corticosteroid administration, and labor induction before and after knowing the ratio value.

Interventions

OTHERBlood sample

Blood sample to analyse the values of sFlt-1 and PlGF

OTHERVascular-renal sample

Usual vascular-renal sample to analyse the values of sFlt-1 and PlGF

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Doctor's medical care decisions on HospitalizationDay 1Initial medical decision (hospitalization or no) was taken before knowing the test result. Revision of the medical decision occurred when the investigators had knowledge of the sFlt-1/PlGF result.

Secondary

MeasureTime frameDescription
Intensive monitoringDay 1Intensive monitoring decision was taken before knowing the test result. Revision of the medical decision occurred when the investigators had knowledge of the sFlt-1/PlGF result.
Corticosteroid administration for lung maturationDay 1Corticosteroid administration for lung maturation decision was taken before knowing the test result. Revision of the medical decision occurred when the investigators had knowledge of the sFlt-1/PlGF result.
Birth inductionDay 1Birth induction decision was taken before knowing the test result. Revision of the medical decision occurred when the investigators had knowledge of the sFlt-1/PlGF result.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026