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Preeclampsia Ratio (sFlt-1/PlGF) (PRECOG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03289611
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : December 28, 2018
Sponsor:
Collaborator:
INSERM CESP1018
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE September 4, 2017
First Posted Date  ICMJE September 21, 2017
Last Update Posted Date December 28, 2018
Actual Study Start Date  ICMJE April 26, 2018
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03289611 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2017)
  • 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
  • Maternal morbidity [ Time Frame: up to 13 weeks ]
    High blood pressure, preeclampsia, caesarean section, postpartum hemorrhage> 500 ml
  • Severe Maternal morbidity (Composite outcome ) [ Time Frame: up to 13 weeks ]
    eclampsia, HELLP syndrome, Disseminated intravascular coagulation, Abruption placenta
  • Number of days between randomisation and delivery [ Time Frame: up to 12 weeks ]
    Number of days between randomisation and delivery
  • Mode of delivery [ Time Frame: At delivery ]
    Cesarean, vaginal delivery
  • Gestational age [ Time Frame: at delivery ]
    Gestational age at delivery
  • Birth weight centile [ Time Frame: At delivery ]
    Centile of birth weight
  • Fetal death [ Time Frame: up to 13 weeks ]
    Fetal death diagnosed at ultrasound before delivery
  • Prematurity before 37 WG [ Time Frame: up to 13 weeks ]
    Delivery before 37 WG + 0 days
  • Prematurity before 34 WG [ Time Frame: Delivery ]
    Delivery before 34 WG + 0 days
  • Prematurity before 32 WG [ Time Frame: Delivery ]
    Delivery before 32 WG + 0 days
  • Perinatal morbidity (Composite outcome) [ Time Frame: At delivery ]
    prematurity, birth weight <10 ° P
  • Severe Perinatal morbidity (Composite outcome) [ Time Frame: At delivery ]
    perinatal mortality, prematurity <34 SA, birth weight <3 ° P
  • Costs [ Time Frame: up to 14 weeks ]
    direct costs of prenatal care, direct costs of neonatal care, total costs
  • Satisfaction form [ Time Frame: Day 3 after delivery ]
    Satisfaction concerning the management of pregnancy and duration of hospitalisation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preeclampsia Ratio (sFlt-1/PlGF)
Official Title  ICMJE Preeclampsia Ratio (sFlt-1/PlGF) Evaluation for Clinical and Obstetrical Guidance
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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Preeclampsia
Intervention  ICMJE Biological: sFlt-1 / PlGF ratio
  • 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
Study Arms  ICMJE
  • No Intervention: Control
    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
    Intervention: Biological: sFlt-1 / PlGF ratio
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 2, 2018)
200
Original Estimated Enrollment  ICMJE
 (submitted: September 20, 2017)
400
Estimated Study Completion Date  ICMJE November 1, 2021
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vassilis Tsatsaris, MD, PhD 1 58 41 38 71 ext +33 vassilis.tsatsaris@aphp.fr
Contact: Laurence Lecomte, PhD 1 58 41 35 45 ext +33 laurence.lecomte@aphp.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03289611
Other Study ID Numbers  ICMJE P161101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE INSERM CESP1018
Investigators  ICMJE
Study Chair: Jean GUIBOURDENCHE, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP