Bryophyllum Pinnatum Treatment of Anxiety Related to Signs of Preterm Birth: a Randomised, Double-blind, Placebo-controlled Study as Investigator-Initiated Trial

BASEC-Nr. 2021-00941

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.

2022-07-12

2023-08-25

2023-10-01

Terminated

Early phase I

60

Inclusion Criteria: * 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 Exclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '48 h after hospitalisation patients can be randomized to the Bryophyllum group or the placebo group.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'double-blind', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

2023-12-13