跳至主要内容
临床试验/NCT03108404
NCT03108404终止不适用

Predictive Score for Neonatal Mortality for Women With Premature Rupture of Membranes Between 22 and 28 Weeks of Gestation

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2017年1月19日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
34
试验地点
2
主要终点
The purpose was to determine which antepartum criteria were efficient to predict neonatal death, in order to create a predictive prognostic antenatal index of mortality.

研究概览

简要总结

Pretern premature rupture of the membranes (PPROM) remains the leading cause of preterm deliveries and neonatal mortality and morbidity. PPROM is defined as rupture of the fetal membranes prior to 37 weeks' gestation. PPROM complicates 2-4% of all pregnancies and accounts for approximately 30 % of preterm births.

The etiology of PPROM remains elusive. PPROM is one of the main causes of prematurity and its complications, such as newborn respiratory distress syndrome, neonatal sepsis, necrotizing enterocolitis, intraventricular hemorrhage, perventricular leucomalacia, varying degrees of lung hypoplasia and bronchopulmonary dysplasia. All these factors contribute greatly to an increase in neonatal morbidity and mortality Management of PPROM followed actual guidelines. Conservative management to prolong a pregnancy is a classical approach to treat PPROM before 34 weeks' gestation in association with antibiotic therapy and corticosteroids.

Maternal and neonatal data were collected from maternal and newborns medical records.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Women with PPROM between 22 weeks and 27 weeks and 6 days are eligible for this study

排除标准

  • Therapeutic abortion / terminaison of pregnancy
  • Intra uterine demise
  • active labor with cervical dilatation of 3 cm with regular contractions.
  • Triplet pregnancies

结局指标

主要结局

The purpose was to determine which antepartum criteria were efficient to predict neonatal death, in order to create a predictive prognostic antenatal index of mortality.

时间窗: 1 day

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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