Bryophyllum Pinnatum Treatment of Anxiety Related to Preterm Labour

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The present IIT (Investigator-Initiated Trial) study is a prospective, randomised, placebo-controlled, double blind trial.

Women with preterm labour, who undergo a 48 h tocolysis cycle and are then clinically stable, can be recruited for the study. Participants will take study medication for up to 9 weeks (until birth or end of premature birth period) 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Christian Haslinger

Criteria

Inclusion Criteria:

• Single pregnancy

• At least 18 years old

• Stable clinical situation after complete tocolysis cycle of 48 h without indication for continuation of tocolysis

• Gestational age at randomisation >28 weeks (28+0) and <34 weeks (33+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 length < 10 mm at beginning of tocolysis

• Contraindication for B. pinnatum, lactose or wheat protein allergy

• Taking Bryophyllum 50% chewable tablets or powder during the last 30 days

• 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