Bryophyllum Pinnatum Treatment of Anxiety Related to Signs of Preterm Birth: a Randomised, Double-blind, Placebo-controlled Study as Investigator-Initiated Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- change in situational state of anxiety
研究概览
简要总结
The present IIT (Investigator-Initiated Trial) study is a prospective, randomised, placebo-controlled, double blind trial.
Women hospitalised with signs of preterm birth can be recruited for the study. Participants will take study medication for 2 weeks (or until birth) and fill out a questionnaire at 3 time points (at baseline, after 1 week and after 2 weeks) to assess state of anxiety and sleep quality. Furthermore, information regarding adverse events and the further course of the pregnancy are recorded.
详细描述
Preterm birth is one of the leading causes for mortality and morbidity in newborns and preterm contractions are the cause of a considerable part of preterm deliveries. In the treatment of preterm labour, tocolytic medications are often used that are associated with numerous side effects for the pregnant woman, which limits their use in time. Preparations from Bryophyllum pinnatum, which demonstrated excellent tolerability, constitute a safe alternative for tocolytic treatment. It was introduced as an alternative tocolytic by anthroposophic medicine in Europe and is used as a monotherapy or add-on therapy for preterm labour in many perinatal clinics in Switzerland today. In vitro studies support the use of B. pinnatum as a tocolytic.
In addition, there are also limited options for the treatment of mental disorders and sleep disturbances during pregnancy. Anxiety plays a major role in the development of preterm labour and often leads to administration of tocolytics longer than necessary. Preparations from B. pinnatum have traditionally been in the treatment of anxiety. Improvements of sleep quality in pregnant women during treatment with B. pinnatum preparations were already shown in previous studies.
This exploratory study aims at investigating the effects of B. pinnatum for the treatment of anxiety in patients with signs of preterm birth.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old
- •Hospitalisation with signs of preterm birth
- •Gestational age at randomisation >22 weeks (22+0) and <35 weeks (34+6)
- •Good German or English skills
- •Written informed consent
排除标准
- •Early premature rupture of the membranes (PPROM)
- •Factors that make soon delivery likely (pre-eclampsia, suspect cardiotocography, clinical signs of an amniotic infection)
- •Body temperature >38°C
- •Cervical opening or cervical length < 5 mm
- •Contraindication for B. pinnatum, lactose or wheat protein allergy
- •Taking Bryophyllum 50% chewable tablets or powder 48 h before study inclusion
- •Taking psychotropic drugs (Benzodiazepines, antidepressants, neuroleptics)
- •Diagnosed psychiatric disease (depression, anxiety disorder, adaptation disorder, post- traumatic stress disorder, bipolar disorder)
- •Active participation in another interventional study during the last 4 weeks
- •Known or suspected non-compliance with study protocol
- •Drug or alcohol abuse
研究组 & 干预措施
Bryophyllum 50%
Participants of the verum group take Bryophyllum 50% chewable tablets starting the day after study inclusion. Participants take 2 tablets, four times a day for 2 weeks. If the birth takes place before the end of the 2 weeks, the study participation is terminated early.
干预措施: Bryophyllum 50% chewable tablets (Drug)
Placebo
Participants of the control group take Placebo chewable tablets starting the day after study inclusion. Participants take 2 tablets, four times a day for 2 weeks. If the birth takes place before the end of the 2 weeks, the study participation is terminated early.
干预措施: Placebo (Other)
结局指标
主要结局
change in situational state of anxiety
时间窗: assessment before treatment, after 1 week and after 2 weeks
assessed with Pregnancy-related Anxiety Questionnaire Revised 2 (PRAQ-R2) values from 10 to 50, higher scores indicating worse state of anxiety
次要结局
- incidence of Adverse Events(up to 9 weeks)
- hospitalisation days(from randomisation till birth or end of preterm period, whichever came first, up to 9 weeks.)
- reached gestational age(at birth)
- change in sleep quality(assessment before treatment, after 1 week and after 2 weeks)
研究者
Christian Haslinger
Principal Investigator
University of Zurich