Bryophyllum Pinnatum Treatment of Anxiety Related to Signs of Preterm Birth
- Conditions
- Preterm LaborAnxiety
- Interventions
- Drug: Bryophyllum 50% chewable tabletsOther: Placebo
- Registration Number
- NCT05110599
- Lead Sponsor
- Christian Haslinger
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bryophyllum 50% Bryophyllum 50% chewable tablets 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. Placebo 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.
- Primary Outcome Measures
Name Time Method change in situational state of anxiety 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
- Secondary Outcome Measures
Name Time Method incidence of Adverse Events up to 9 weeks occurence of Adverse Events
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 assessed with Pittsburgh Sleep Quality Index (PSQI) values from 0 to 21, higher scores indicating worse sleep quality
Trial Locations
- Locations (1)
University Hospital Zurich
🇨🇭Zürich, Switzerland