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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A03384-35 | Other Identifier | IDRCB |
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It consists of evaluating the advantage of routine detection of phIGFBP-1 to reduce the total duration of hospitalization for patients with a risk of preterm labor before 32 weeks of gestation without increasing the number of preterm labour.
Patient with a risk of preterm labor (ultrasound cervical length < 25 mm +/- described or recorded uterine contractions) before 32 weeks of gestation will be hospitalized to receive tocolytic drugs and antenatal corticosteroid therapy according to the investigators gold standard protocol. After 48 hours, the participants will be assessed by examination, external tocodynamometry and the measure of cervical length by ultrasound. Stabilized patients will be included and randomized into 2 groups of 210 patients each. The first group "A" will benefit from the standard protocol (extended hospitalization of 2 or 4 days according to the clinical and ultrasound assessment); whereas the second group, "B", will have the benefit of the detection of phIGFBP-1.If the result proves negative, patients could be discharged early at day 2. In the case of a positive result, patients will follow the standard procedure because of the low positive predictive value of the test. The main outcome is the total duration of hospitalization.
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| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence rate of the composite end point | including cardiovascular death, acute heart failure, cardiogenic shock, cardiac arrest, sustained ventricular tachycardia, ventricular fibrillation, 2nd-degree (except Mobitz 1) or 3rd-degree atrioventricular block. | 6-month |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence rate of all-cause death | 6-month |
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Inclusion Criteria:
All patients affiliated to the French social security system will be eligible, after signing a consent form, and presenting the following criteria
Introduction within the last 3 months of at least one of the following ICIs: nivolumab, pembrolizumab, cemiplimab, avelumab, atezolizumab, ipilimumab, tremelimumab, durvalumab.
Suspicion of myocarditis defined by the presence of at least one of the following criteria adapted from the European Society of Cardiology guidelines:
Patient has given no objection
Translated with www.DeepL.com/Translator (free version)
Exclusion Criteria:
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all patients with suspected myocarditis on ICIs.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| DEHARO PIERRE | Contact | (0)4 91 96 86 83 | +33 | pierre.deharo@ap-hm.fr |
| Name | Affiliation | Role |
|---|---|---|
| François CREMIEUX | Assistance Publique Hopitaux De Marseille | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| assistance publique hôpitaux de Marseille | Recruiting | Marseille | 13354 | France |
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| ID | Term |
|---|---|
| D009205 | Myocarditis |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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