CEFTRIAXONE SODIUM for Threatened late miscarriage | Threatened abortion antepartum

Inclusion criteria

• {"criterion_text":"- Threat of late miscarriage with intact membranes between 18 0/7 and 23 6/7 weeks of gestation, defined by transvaginal ultrasound as a cervix ≤10 mm, and/or protrusion of the amniotic sac observed with a speculum.\n- Singleton pregnancy\n- Living fetus at the time of inclusion\n- Maternal age >18 years\n- Absence of regular and painful uterine contractions\n- Adequate understanding of the French language\n- Affiliated with social security"}

Exclusion criteria

• {"criterion_text":"- Preterm labor defined by regular and painful uterine contractions, and a short cervix\n- Patient under state medical aid (AME) if not exempted from the affiliation requirement\n- Protected person (patient under guardianship/curatorship/legal protection)\n- Multiple pregnancies\n- Premature rupture of membranes\n- Acute chorioamnionitis\n- Contraindication to the antibiotics in the protocol\n- Chromosomal anomaly, congenital malformation\n- Patients who have received antibiotics before inclusion or who require antibiotics for another indication (chorioamnionitis, pyelonephritis, etc.)\n- Participation in another interventional research study or being in the exclusion period following a previous study involving human subjects, if applicable"}

Primary endpoints

• {"endpoint_text":"- Composite criterion combining late miscarriage, perinatal mortality, and/or severe neonatal morbidity occurring before hospital discharge, including: 1-Late miscarriage","definition_or_measurement_approach":"Composite combining late miscarriage, perinatal mortality and severe neonatal morbidity occurring before hospital discharge (as stated)."}
• {"endpoint_text":"- Perinatal mortality","definition_or_measurement_approach":""}
• {"endpoint_text":"- Bronchopulmonary dysplasia","definition_or_measurement_approach":""}
• {"endpoint_text":"- Sepsis proven by blood culture","definition_or_measurement_approach":"Diagnosis proven by positive blood culture."}
• {"endpoint_text":"- Intraventricular hemorrhage ≥ Grade 3","definition_or_measurement_approach":""}
• {"endpoint_text":"- Periventricular leukomalacia ≥ Grade 2","definition_or_measurement_approach":""}
• {"endpoint_text":"- Necrotizing enterocolitis at stage ≥ 2 according to Bell's classification","definition_or_measurement_approach":"Staging according to Bell's classification (stage ≥2)."}

Secondary endpoints

• {"endpoint_text":"- Each item of the composite criterion: 1-Neonatal mortality and late miscarriage","definition_or_measurement_approach":""}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Diagnosis per Jobe and Bancalari criteria at discharge or corrected age 36 6/7 weeks."}
• {"endpoint_text":"- Sepsis proven by culture, diagnosed by a combination of clinical signs and a positive blood culture","definition_or_measurement_approach":"Diagnosis requires clinical signs plus positive culture (blood culture)."}
• {"endpoint_text":"- Intraventricular hemorrhage ≥ Grade 3 and/or periventricular leukomalacia, diagnosed by repeated transfontanellar ultrasounds (according to the classification of Vries and Ment)","definition_or_measurement_approach":"Diagnosis by repeated transfontanellar ultrasounds using Vries and Ment classification."}
• {"endpoint_text":"- Necrotizing enterocolitis ≥ Stage 2, using Bell's classification.","definition_or_measurement_approach":"Staging according to Bell's classification (≥ Stage 2)."}

France

Earliest CTIS Part Ii Submission Date

06-08-2024

Latest Decision Or Authorization Date

19-09-2024

Processing Time Days

44

Number Of Sites

13

Number Of Participants

350

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"Ministry of Health","duties_or_roles":"Monetary support","organisation_type":""}