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临床试验/NCT00163579
NCT00163579已完成4 期

The Impact of the Prophylactic or Therapeutic Application of Bryophyllum on Preterm Delivery - a Prospective Study

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2004年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
26
试验地点
1
主要终点
Extension of pregnancy

研究概览

简要总结

The purpose of this study is whether Bryophyllum is more effective and has less side effects than traditional labor inhibitors in preventing preterm delivery.

详细描述

Preterm delivery (delivery before 37 +0 weeks of gestation) is still the leading cause of perinatal mortality and morbidity in the western countries. Due to this fact it is only possible to achieve the mortality rate of 5‰, aspired by WHO, by an effective decrease of the current preterm delivery rate.

An exact ascertainment of the etiology of preterm delivery is hardly possible, because multiple, partly overlapping or multifactorial etiologies exist. Various pathologies (e.g. of the placenta, fetus uterus or endocrine dysfunctions) may lead to preterm deliveries or preterm contractions.

Traditional diagnostic tools for preterm contractions/preterm deliveries has consisted of clinical examinations (digital palpation of the cervix) and the recording of the contractions by the tocogram. Both methods have a low sensitivity and predictive values. Furthermore the clinical examination has a high interobserver variability of 29%.

With the introduction of transvaginal sonographic measurements, the sensitivity for preterm deliveries could substantially be elevated.

Despite intensive efforts in the field of preventive care, screening and therapeutic interventions (e.g. the use of tocolytics), the incidence of preterm deliveries has remained stable for over two decades.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All multiple pregnancies Singleton pregnancies with preterm contractions/cervix < 25mm, or singleton pregnancies with burdened maternal anamnesis (e.g. prior preterm delivery preterm contractions cerclage).

排除标准

  • Fetal malformations
  • Chromosomal anomalies
  • Intrauterine growth restriction

研究组 & 干预措施

Bryophyllum

Experimental

干预措施: Bryophyllum (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Other)

结局指标

主要结局

Extension of pregnancy

次要结局

  • Rate of preterm deliveries, rate of side effects, days of hospitalisation, rate of lung maturation.

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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