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Echec-MAT - A combination of antibiotics to improve neonatal mortality and morbidity for pregnancies complicated with previable labour and intact membranes: an open multiple center, randomized, and controlled trial

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505500-37-00
Acronym
APHP220670
Enrollment
350
Registered
2024-09-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnant women with singleton pregnancies hospitalized for threatened late miscarriage with intact membranes

Brief summary

Composite criterion combining late miscarriage, perinatal mortality, and/or severe neonatal morbidity occurring before hospital discharge, including: 1-Late miscarriage, Perinatal mortality, Bronchopulmonary dysplasia, Sepsis proven by blood culture, Intraventricular hemorrhage ≥ Grade 3, Periventricular leukomalacia ≥ Grade 2, Necrotizing enterocolitis at stage ≥ 2 according to Bell's classification

Detailed description

Each item of the composite criterion: 1-Neonatal mortality and late miscarriage, Bronchopulmonary dysplasia according to international recommendations (described by Jobe and Bancalari), diagnosed at discharge or at a corrected age of 36 6/7 weeks of gestation., Sepsis proven by culture, diagnosed by a combination of clinical signs and a positive blood culture, Intraventricular hemorrhage ≥ Grade 3 and/or periventricular leukomalacia, diagnosed by repeated transfontanellar ultrasounds (according to the classification of Vries and Ment), Necrotizing enterocolitis ≥ Stage 2, using Bell's classification.

Interventions

DRUGCEFTRIAXONE VIATRIS 1 g
DRUGpoudre pour solution injectable
DRUGClarithromycine EG 500 mg comprimés pelliculés
DRUGMÉTRONIDAZOLE ARROW 500 mg

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Composite criterion combining late miscarriage, perinatal mortality, and/or severe neonatal morbidity occurring before hospital discharge, including: 1-Late miscarriage, Perinatal mortality, Bronchopulmonary dysplasia, Sepsis proven by blood culture, Intraventricular hemorrhage ≥ Grade 3, Periventricular leukomalacia ≥ Grade 2, Necrotizing enterocolitis at stage ≥ 2 according to Bell's classification

Secondary

MeasureTime frame
Each item of the composite criterion: 1-Neonatal mortality and late miscarriage, Bronchopulmonary dysplasia according to international recommendations (described by Jobe and Bancalari), diagnosed at discharge or at a corrected age of 36 6/7 weeks of gestation., Sepsis proven by culture, diagnosed by a combination of clinical signs and a positive blood culture, Intraventricular hemorrhage ≥ Grade 3 and/or periventricular leukomalacia, diagnosed by repeated transfontanellar ultrasounds (according to the classification of Vries and Ment), Necrotizing enterocolitis ≥ Stage 2, using Bell's classification.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026