ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : May 10, 2018
Sponsor:
Collaborator:
INSERM CESP1018
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Preeclampsia Biological: sFlt-1 / PlGF ratio Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Preeclampsia Ratio (sFlt-1/PlGF) Evaluation for Clinical and Obstetrical Guidance
Actual Study Start Date : April 26, 2018
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patient hospitalized for suspected preeclampsia between 24WG+ 0 days and 34WG + 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289611


Contacts
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

Locations
France
CHU Cochin, Maternité Port Royal Recruiting
Paris, France, 75014
Contact: Vassilis Tsatsaris, MD, PhD    1 58 4 138 71 ext +33    Vassilis.tsatsaris@aphp.fr   
Contact: Laurence Lecomte, PhD    1 58 41 35 45 ext +33    laurence.lecomte@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
INSERM CESP1018
Investigators
Study Chair: Jean GUIBOURDENCHE, MD, PhD Assistance Publique - Hôpitaux de Paris

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03289611     History of Changes
Other Study ID Numbers: P161101
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Preeclampsia
pregnancy
biomarkers
prediction
safety
cost

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications