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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 9
- 主要终点
- Composite criterion combining late miscarriage, perinatal mortality, and/or severe neonatal morbidity occurring before hospital discharge, including: 1-Late miscarriage
研究概览
简要总结
Reduce neonatal mortality and severe morbidity by prolonging pregnancies complicated by the threat of late miscarriage with intact membranes
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
- •Singleton pregnancy
- •Living fetus at the time of inclusion
- •Maternal age >18 years
- •Absence of regular and painful uterine contractions
- •Adequate understanding of the French language
- •Affiliated with social security
排除标准
- •Preterm labor defined by regular and painful uterine contractions, and a short cervix
- •Patient under state medical aid (AME) if not exempted from the affiliation requirement
- •Protected person (patient under guardianship/curatorship/legal protection)
- •Multiple pregnancies
- •Premature rupture of membranes
- •Acute chorioamnionitis
- •Contraindication to the antibiotics in the protocol
- •Chromosomal anomaly, congenital malformation
- •Patients who have received antibiotics before inclusion or who require antibiotics for another indication (chorioamnionitis, pyelonephritis, etc.)
- •Participation in another interventional research study or being in the exclusion period following a previous study involving human subjects, if applicable
结局指标
主要结局
Composite criterion combining late miscarriage, perinatal mortality, and/or severe neonatal morbidity occurring before hospital discharge, including: 1-Late miscarriage
Composite criterion combining late miscarriage, perinatal mortality, and/or severe neonatal morbidity occurring before hospital discharge, including: 1-Late miscarriage
Perinatal mortality
Perinatal mortality
Bronchopulmonary dysplasia
Bronchopulmonary dysplasia
Sepsis proven by blood culture
Sepsis proven by blood culture
Intraventricular hemorrhage ≥ Grade 3
Intraventricular hemorrhage ≥ Grade 3
Periventricular leukomalacia ≥ Grade 2
Periventricular leukomalacia ≥ Grade 2
Necrotizing enterocolitis at stage ≥ 2 according to Bell's classification
Necrotizing enterocolitis at stage ≥ 2 according to Bell's classification
次要结局
- 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.
研究者
coordinating investigator
Scientific
Assistance Publique Hopitaux De Paris