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Completed

NCT Number: NCT03289611

Preeclampsia Ratio (sFlt-1/PlGF)

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Cochin, Maternité Port Royal

Paris, 75014, France

About this study

Preeclampsia is a hypertensive disorder of pregnancy associated with placental insufficiency and is one of the major important of prematurity and maternal mortality worldwide. It complicates 2 to 7% of pregnancies. It is currently considered that preeclampsia is associated with maternal endothelial dysfunction induced by the release into the maternal circulation of excess placental factors (such as sFLT-1 a soluble receptor for VEGF and PlGF). There is currently no curative treatment, and only childbirth and delivery of the placenta alleviate the mother's symptoms. Moreover, the evolution from case with mild symptoms to a severe case of preeclampsia is often is often rapid and difficult to anticipate. Therefore, it is recommended to manage patients with preeclampsia in hospital and cases of suspected preeclampsia are usually admitted in prenatal units. Each year thousands of patients are hospitalized for surveillance and blood/urine analysis to rule out the diagnosis of preeclampsia. A biological test to predict preeclampsia would therefore be of particular interest in order to:

  • identify patients without preeclampsia and therefore void costs and iatrogenic complications related to unnecessary hospitalization
  • identify patients at high risk of maternal and perinatal complications in order to anticipate in utero transfer, optimize maternal and fetal surveillance and administrate steroids.

It has recently been demonstrated that sFLT-1 and PlGF have a high predictive value for the diagnosis and the prediction of preeclampsia, but the interest of introducing these markers in clinical practice has not been demonstrated yet. The diagnostic and predictive value of the sFlt-1/PlGF ratio in patients at risk of placenta-related disorders has been shown in the recent literature and estimation of the sFlt-1/PlGF ratio has become an additional tool in the management of these disorders, primarily PE. This ratio can distinguish the patients that develop maternal or perinatal complications in the next 7-14 days from those with uncomplicated pregnancy. Women with an sFlt-1/PlGF ratio<38 do not have PE at the time of the test and in all likelihood will not develop PE for at least 1week; it is thereby of great value for reassuring the clinician and the patient. Up to 80% of patients are supposed to be in this patient group; therefore, clinicians are able to exclude the majority of patients and focus on those who need more attention and care. On contrary women with a sFlt-1/PlGF ratio > 38 and more specifically those with a ratio over 85 are highly likely to develop preeclampsia and should be managed according to local practice/guidelines. Thus the use of such predictive tool appear very promising but its interest has not been demonstrated in prospective intervention studies.

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 WG. costs, in patients with suspected preeclampsia before 35 WG.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

  1. number of patients hospitalised for more than 24 hours

    Time frame: up to 12 weeks

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

Secondary outcomes

  1. Maternal and fetal morbidity

    Time frame: up to 13 weeks

    severe preeclampsia, eclampsia, HELLP syndrome, Disseminated intravascular coagulation, abruptio placenta, delivery before 34 WA, IUGR< 3°P, Fetal death

  2. Maternal morbidity

    Time frame: up to 13 weeks

    High blood pressure, preeclampsia, caesarean section, postpartum hemorrhage> 500 ml

  3. Severe Maternal morbidity (Composite outcome )

    Time frame: up to 13 weeks

    eclampsia, HELLP syndrome, Disseminated intravascular coagulation, Abruption placenta

  4. Number of days between randomisation and delivery

    Time frame: up to 12 weeks

    Number of days between randomisation and delivery

  5. Mode of delivery

    Time frame: At delivery

    Cesarean, vaginal delivery

  6. Gestational age

    Time frame: at delivery

    Gestational age at delivery

  7. Birth weight centile

    Time frame: At delivery

    Centile of birth weight

  8. Fetal death

    Time frame: up to 13 weeks

    Fetal death diagnosed at ultrasound before delivery

  9. Prematurity before 37 WG

    Time frame: up to 13 weeks

    Delivery before 37 WG + 0 days

  10. Prematurity before 34 WG

    Time frame: Delivery

    Delivery before 34 WG + 0 days

  11. Prematurity before 32 WG

    Time frame: Delivery

    Delivery before 32 WG + 0 days

  12. Perinatal morbidity (Composite outcome)

    Time frame: At delivery

    prematurity, birth weight <10 ° P

  13. Severe Perinatal morbidity (Composite outcome)

    Time frame: At delivery

    perinatal mortality, prematurity <34 SA, birth weight <3 ° P

  14. Costs

    Time frame: up to 14 weeks

    direct costs of prenatal care, direct costs of neonatal care, total costs

  15. Satisfaction form

    Time frame: Day 3 after delivery

    Satisfaction concerning the management of pregnancy and duration of hospitalisation

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Preeclampsia Ratio (sFlt-1/PlGF) Evaluation for Clinical and Obstetrical Guidance

Acronym: PRECOG

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 21, 2017
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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