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

NCT06314555 | Completed

• 1 other identifier: CEROG2023
• Study Type: observational
• Target: 314
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia Possible

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Intensive monitoring

  Day 1

• Corticosteroid administration for lung maturation

  Day 1

• Birth induction

  Day 1

Study Arms (2)

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; Other: Vascular-renal sample

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; Other: Vascular-renal sample

Interventions

Blood sample OTHER

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

Women above 37 weeks of gestation age; Women under 37 weeks of gestation age

Vascular-renal sample OTHER

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

Women above 37 weeks of gestation age; Women under 37 weeks of gestation age

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint Etienne

Saint-Etienne, 42100, France

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Tiphaine BARJAT, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: October 1, 2019
• Primary Completion: January 27, 2021
• Study Completion: January 27, 2021
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)