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

NCT06224946 | Completed

• 1 other identifier: CEROG 2022-OBS-0401
• 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. 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

Conditions

Pre-Eclampsia

Keywords

Pre-Eclampsia; Placental Growth Factor; Soluble fms-like tyrosine Kinase; medical Care decision

Outcome Measures

Primary Outcomes (1)

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

  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.

  day 1

Study Arms (2)

women under 37 weeks of gestation age

217 women under 37 weeks of gestation age

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

women above 37 weeks of gestation age

97 women above 37 weeks of gestation age

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

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

314 patients were included: 217 women under 37 weeks of gestation age and 97 women above this age.

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, 42055, France

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

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

Study Officials

• BARJAT Tiphaine, MD

  CHU DE SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 25, 2024
• Study Start: October 1, 2019
• Primary Completion: January 27, 2021
• Study Completion: January 27, 2021
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)