PreeclampsiaPRECOGNCT03289611
Preeclampsia Ratio (sFlt-1/PlGF)
A study testing sFlt-1 / PlGF ratio in people with Preeclampsia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- sFlt-1 / PlGF ratio
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2018to 27 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- Non-consent of patient
- Minor patient
- Congenital malformation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preeclampsia Ratio (sFlt-1/PlGF) Evaluation for Clinical and Obstetrical Guidance
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.
Read the 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.
- Conditions
- Preeclampsia
- Being tested
- sFlt-1 / PlGF ratio
- Keywords
- Preeclampsia, pregnancy, biomarkers, prediction, safety, cost
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sFlt-1 / PlGF ratioBiological
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: sFlt-1 / PlGF ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients hospitalised for more than 24 hours
Duration in hours, from admission to discharge from hospital at initial hospitalisation
Measured: up to 12 weeks
Secondary outcomes (15)
Maternal and fetal morbidity
severe preeclampsia, eclampsia, HELLP syndrome, Disseminated intravascular coagulation, abruptio placenta, delivery before 34 WA, IUGR< 3°P, Fetal death
Measured: up to 13 weeks
Maternal morbidity
High blood pressure, preeclampsia, caesarean section, postpartum hemorrhage> 500 ml
Measured: up to 13 weeks
Severe Maternal morbidity (Composite outcome )
eclampsia, HELLP syndrome, Disseminated intravascular coagulation, Abruption placenta
Measured: up to 13 weeks
Number of days between randomisation and delivery
Number of days between randomisation and delivery
Measured: up to 12 weeks
Mode of delivery
Cesarean, vaginal delivery
Measured: At delivery
Gestational age
Gestational age at delivery
Measured: at delivery
Birth weight centile
Centile of birth weight
Measured: At delivery
Fetal death
Fetal death diagnosed at ultrasound before delivery
Measured: up to 13 weeks
Prematurity before 37 WG
Delivery before 37 WG + 0 days
Measured: up to 13 weeks
Prematurity before 34 WG
Delivery before 34 WG + 0 days
Measured: Delivery
Prematurity before 32 WG
Delivery before 32 WG + 0 days
Measured: Delivery
Perinatal morbidity (Composite outcome)
prematurity, birth weight <10 ° P
Measured: At delivery
Severe Perinatal morbidity (Composite outcome)
perinatal mortality, prematurity <34 SA, birth weight <3 ° P
Measured: At delivery
Costs
direct costs of prenatal care, direct costs of neonatal care, total costs
Measured: up to 14 weeks
Satisfaction form
Satisfaction concerning the management of pregnancy and duration of hospitalisation
Measured: Day 3 after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start26 Apr 2018
- Primary completion27 Aug 2020
- Study completion27 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Jean GUIBOURDENCHE, MD, PhD, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289611
- Sponsor's protocol ID
- P161101
- Acronym
- PRECOG
- Status last verified
- Mar 2026
- First submitted
- 4 Sep 2017
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 14602804Sibiude 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.
PubMed 23209675Zeisler 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.
PubMed 26735990Lorut 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.
PubMed 24292873
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preeclampsia Ratio (sFlt-1/PlGF) Evaluation for Clinical and Obstetrical Guidance
- ClinicalTrials.gov ID
- NCT03289611
- Acronym / sponsor ID
- PRECOG / P161101
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia, pregnancy, biomarkers, prediction, safety, cost
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 27 Aug 2020 (actual)
- Study completion
- 27 Aug 2020 (actual)
- First posted
- 21 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual management |
| Experimental | Experimental | Biological: sFlt-1 / PlGF ratioAmbulatory 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient hospitalized for suspected preeclampsia between 24WG+ 0 days and 35WG + 6 days,
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Biological | Experimental |
Primary outcome
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
15 secondary outcomes
Maternal and fetal morbidity
Time frame: up to 13 weeks
Maternal morbidity
Time frame: up to 13 weeks
Severe Maternal morbidity (Composite outcome )
Time frame: up to 13 weeks
Number of days between randomisation and delivery
Time frame: up to 12 weeks
Mode of delivery
Time frame: At delivery
Gestational age
Time frame: at delivery
Birth weight centile
Time frame: At delivery
Fetal death
Time frame: up to 13 weeks
Prematurity before 37 WG
Time frame: up to 13 weeks
Prematurity before 34 WG
Time frame: Delivery
Prematurity before 32 WG
Time frame: Delivery
Perinatal morbidity (Composite outcome)
Time frame: At delivery
Severe Perinatal morbidity (Composite outcome)
Time frame: At delivery
Costs
Time frame: up to 14 weeks
Satisfaction form
Time frame: Day 3 after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Background: PubMed 14602804Tsatsaris 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.
- Background: PubMed 23209675Sibiude 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.
- Background: PubMed 26735990Zeisler 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.
- Results publication: PubMed 24292873Lorut 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.
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Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean GUIBOURDENCHE, MD, PhD study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sFlt-1 / PlGF ratio in people with Preeclampsia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients hospitalised for more than 24 hours (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03289611, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.