UnknownNot Applicable

Interest of sFlt1/PlGF Ratio at Obstetric Emergencies

France150 participantsStarted 2019-11-18

Plain-language summary

In patients with suspected placental vascular disease who do not require hospitalization, the use of the sFlt-1 (Soluble FMS like tyrosin-kinase-1)/PlGF (Placental Growth Factor)/ assay can most likely help teams to define the best possible management.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 18 years old * Pregnant patients term ≥ at 24 weeks of amenorrhoea (SA), * Management in obstetrical emergencies and at the Centre Hopsitalier Intercommunal (CHI) de Créteil functional exploration center, with prescription of a vascular-renal check-up (BVR) ((proteinuria/creatinuria ratio, blood count, platelets, blood ionogram, creatinemia, transaminases (ASAT, ALAT), haptoglobulinemia, lactate dehydrogenase (LDH), TP). * Presenting either one of the following isolated or associated clinical parameters: * HyperTension * urinary tape proteinuria * functional signs of hypertension (headaches, phosphenes, accouphènes) * live osteotendinous reflexes * epigastric pains * weight gain, lower limb edema, facial edema * oliguria * vomiting * or one of the following isolated or associated ultrasound parameters: * fetal hypotrophy, fetal growth deflection * fetal Doppler abnormalities (umbilical Doppler, cerebral Doppler) * ooligo-anamnios with intact membranes * patient who has been informed and has given her oral non-opposition Exclusion Criteria: * Diagnosis of preeclampsia * Refusal of the patient * Patient whose symptomatology (clinical or paraclinical) leads to a decision to be hospitalized * Age \< 18 years old * Non-affiliation to the general social security system

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reconvening period in patients with an sFlt1 (Soluble FMS like tyrosin-kinase-1)/PlGF (Placental Growth Factor) ratio <38 (day)

Timeframe: trough participation period, an average of 4 months

Trial details

NCT IDNCT04170660

SponsorCentre Hospitalier Intercommunal Creteil

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-11

View on ClinicalTrials.gov More Suspected Placental Dysfunction, Ruled Out trials