Preeclampsia Ratio (sFlt-1/PlGF)

NCT03289611 | Completed

• 1 other identifier: P161101
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the PRECOG study is to determine in a prospective interventional randomized study whether the implementation of a predictive test based on the sFLT-1/PlGF ratio improves perinatal care and reduces costs, in patients with suspected preeclampsia before 35 weeks of gestation.

Conditions

Preeclampsia

Keywords

Preeclampsia; pregnancy; biomarkers; prediction; safety; cost

Outcome Measures

Primary Outcomes (1)

• number of patients hospitalised for more than 24 hours

  Duration in hours, from admission to discharge from hospital at initial hospitalisation

  up to 12 weeks

Secondary Outcomes (15)

• Maternal and fetal morbidity

  up to 13 weeks

• Maternal morbidity

  up to 13 weeks

• Severe Maternal morbidity (Composite outcome )

  up to 13 weeks

• Number of days between randomisation and delivery

  up to 12 weeks

• Mode of delivery

  At delivery

Study Arms (2)

Control

NO INTERVENTION

Usual management

Experimental

EXPERIMENTAL

Ambulatory management if sFlt-1 / PlGF ratio is below 38 Usual management if sFlt-1/PlGF is between 38 and 85. If the ratio is \> 85, monitoring will be intensified and patient hospitalization will be continued

Biological: sFlt-1 / PlGF ratio

Interventions

sFlt-1 / PlGF ratio BIOLOGICAL

* Ambulatory management if sFlt-1 / PlGF ratio is below 38 * usual management if sFlt-1/PlGF is between 38 and 85. * If the ratio is \> 85, monitoring will be intensified and patient hospitalization will be continued

Experimental

Eligibility Criteria

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

You may qualify if:

• Patient hospitalized for suspected preeclampsia between 24WG+ 0 days and 35WG + 6 days,
• Patiente with at least one of the following criteria:
• Arterial hypertension defined by systolic BP ≥ 140 mm Hg or diastolic blood pressure ≥ 90 mm Hg
• Proteinuria greater than 0.3g / 24h or 0.3g / l or ≥ 3+
• Proteinuria / creatinine ratio ≥ 30 mg / mmol
• Pain in the epigastric bar
• Generalized edema
• Hepatic cytolysis\> 1.5N
• Thrombocytopenia \<150000 / mm3 Informed consent signed by both parties Non-opposition was accepted by parental authority Age ≥ 18 years

You may not qualify if:

• Diagnosis of preeclampsia (arterial pressure\> 140/90 and proteinuria\> 0.3g / 24h or urine test\> 3+) or complete HELLP syndrome (Platelets \<100000 / mm3 and SGOT\> 2N and LDH and collapsed Haptoglobin)
• IUGR with absent or reverse diastolic umbilical flow
• Fetal heart rate abnormalities
• Gestational age \<24 WG and\> 35 WG
• Multiple pregnancy
• Patient without health insurance
• Non-consent of patient
• Minor patient
• Congenital malformation

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

CHU Cochin, Maternité Port Royal

Paris, 75014, France

Location

Related Publications (4)

• Tsatsaris V, Goffin F, Munaut C, Brichant JF, Pignon MR, Noel A, Schaaps JP, Cabrol D, Frankenne F, Foidart JM. Overexpression of the soluble vascular endothelial growth factor receptor in preeclamptic patients: pathophysiological consequences. J Clin Endocrinol Metab. 2003 Nov;88(11):5555-63. doi: 10.1210/jc.2003-030528.

  PMID: 14602804 BACKGROUND

• Sibiude J, Guibourdenche J, Dionne MD, Le Ray C, Anselem O, Serreau R, Goffinet F, Tsatsaris V. Placental growth factor for the prediction of adverse outcomes in patients with suspected preeclampsia or intrauterine growth restriction. PLoS One. 2012;7(11):e50208. doi: 10.1371/journal.pone.0050208. Epub 2012 Nov 28.

  PMID: 23209675 BACKGROUND

• Zeisler H, Llurba E, Chantraine F, Vatish M, Staff AC, Sennstrom M, Olovsson M, Brennecke SP, Stepan H, Allegranza D, Dilba P, Schoedl M, Hund M, Verlohren S. Predictive Value of the sFlt-1:PlGF Ratio in Women with Suspected Preeclampsia. N Engl J Med. 2016 Jan 7;374(1):13-22. doi: 10.1056/NEJMoa1414838.

  PMID: 26735990 BACKGROUND

• Lorut C, Lefebvre A, Planquette B, Quinquis L, Clavier H, Santelmo N, Hanna HA, Bellenot F, Regnard JF, Riquet M, Magdeleinat P, Meyer G, Roche N, Huchon G, Coste J, Rabbat A. Early postoperative prophylactic noninvasive ventilation after major lung resection in COPD patients: a randomized controlled trial. Intensive Care Med. 2014 Feb;40(2):220-227. doi: 10.1007/s00134-013-3150-2. Epub 2013 Nov 29.

  PMID: 24292873 RESULT

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

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

Study Officials

• Jean GUIBOURDENCHE, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 21, 2017
• Study Start: April 26, 2018
• Primary Completion: August 27, 2020
• Study Completion: August 27, 2020
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

FR (1)