Impact of the sFlt-1/PlGF Ratio on Medical Decision-making and on Maternal and Neonatal Outcomes 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.

Study Overview

• Status: Completed
• Conditions: Preeclampsia Possible
• Intervention / Treatment: Other: Blood sample; Other: Vascular-renal sample

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.

• Study Type: Observational
• Enrollment (Actual): 314

Contacts and Locations

Study Locations

• France
  • St Etienne, France, 42100
    • CHU Saint Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women suspected of preeclampsia, above 24 weeks of gestation.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women under 37 weeks of gestation age; A woman with suspected preeclampsia and with inclusion criteria receives a blood sample, according to the department's usual practices, to analyse the values of sFlt-1 and PlGF and the usual vascular-renal sample. The woman gave her verbal consent to participate in the study. The Roche Elecsys® immunoassay sFlt-1/PlGF ratio was used to measure the two markers in the patients' blood.	Other: Blood sample; Blood sample to analyse the values of sFlt-1 and PlGF; Other: Vascular-renal sample; Usual vascular-renal sample to analyse the values of sFlt-1 and PlGF
Women above 37 weeks of gestation age; A woman with suspected preeclampsia and with inclusion criteria receives a blood sample, according to the department's usual practices, to analyse the values of sFlt-1 and PlGF and the usual vascular-renal sample. The woman gave her verbal consent to participate in the study. The Roche Elecsys® immunoassay sFlt-1/PlGF ratio was used to measure the two markers in the patients' blood.	Other: Blood sample; Blood sample to analyse the values of sFlt-1 and PlGF; Other: Vascular-renal sample; Usual vascular-renal sample to analyse the values of sFlt-1 and PlGF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Doctor's medical care decisions on Hospitalization	Initial 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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensive monitoring	Intensive 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.	Day 1
Corticosteroid administration for lung maturation	Corticosteroid 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.	Day 1
Birth induction	Birth 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.	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Tiphaine BARJAT, MD PhD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): January 27, 2021
• Study Completion (Actual): January 27, 2021

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Placental growth factor; Preeclampsia; Hospitalization; Soluble fms-like tyrosine kinase; Medical care decision
• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pre-Eclampsia
• Other Study ID Numbers: CEROG2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No