The Impact of Bryophyllum on Preterm Delivery
Condition: Preterm Delivery; Preterm Contractions; Cervical Shortening
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 4

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

Detailed description: 
      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.

      For inhibiting labor, beta-mimetics has been utilised for over 20 years. Beta mimetics are
      currently able to prevent preterm labor in average for approximately 48 hours. Other
      medicaments with tocolytic properties include calcium antagonists, prostaglandin inhibitors
      and currently, antagonists of the oxytocic receptor.

      However, conventional labor inhibitors show considerable side effects, such as cardiovascular
      effects (e.g.tachycardia) or tremor in case of beta mimetics.

      Due to the stagnant long-term results of the conventional labor inhibitors, we are looking
      for alternative medicaments, especially with a lower side effect profile.

      The phytopharmacon Bryophyllum, which is produced from the leaves of Bryophyllum pinnatum, is
      available as a 5% aqueous tincture, 33% dilution or 50% trituration.

      Bryophyllum has been used since 1970 for tocolysis, either orally or intravenously. However,
      because of its predominant use in anthroposophical clinics, clinical trials for its
      evaluation has been rarely performed. Currently, in vitro studies endorsed the inhibition of
      myometrial contractibility. In contrast to conventional labor inhibitors, side effects has
      been only occasionally observed in case of Bryophyllum (e.g. skin irritation).

      To evaluate the tocolytic effects of orally applicated Bryophyllum versus Placebo in case of
      patients with preterm contractions, twin pregnancies and patients with a risk for preterm
      delivery, due to previous preterm contractions/preterm deliveries.

      Bryophyllum or Placebo will be given prophylactic or, parallel with conventional labor
      inhibitors in case of preterm contractions.
    

Intervention name(s): Bryophyllum; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: premature birth; cerclage; tocolysis; drug therapy