The Impact of Bryophyllum on Preterm Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00163579
Recruitment Status : Unknown
Verified September 2005 by Basel Women’s University Hospital.
Recruitment status was:  Recruiting
First Posted : September 14, 2005
Last Update Posted : April 16, 2009
Information provided by:
Basel Women’s University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Preterm Delivery Preterm Contractions Cervical Shortening Drug: Bryophyllum Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: The Impact of the Prophylactic or Therapeutic Application of Bryophyllum on Preterm Delivery - a Prospective Study
Study Start Date : July 2004
Estimated Study Completion Date : March 2007

Primary Outcome Measures :
  1. Extension of pregnancy

Secondary Outcome Measures :
  1. Rate of preterm deliveries, rate of side effects, days of hospitalisation, rate of lung maturation.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

All multiple pregnancies Singleton pregnancies with preterm contractions/cervix < 25mm, or singleton pregnancies with burdened maternal anamnesis (e.g. prior preterm delivery preterm contractions cerclage).

Exclusion Criteria:

  • Fetal malformations
  • Chromosomal anomalies
  • Intrauterine growth restriction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00163579

Contact: Olav Lapaire, MD 01-6176361468
Contact: Irène Hoesli, MD 0041 61 265 90 17

Obstetrical Unit, Women's University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Irène Hoesli, MD    0041 61 265 90 17   
Contact: Wolfgang Holzgreve, Professor    0041 61 265 90 99   
Principal Investigator: Irène Hoesli, MD         
Sponsors and Collaborators
Basel Women’s University Hospital
Principal Investigator: Irène Hoesli, MD Women's University Hospital, Basel, Switzerland

Publications: Identifier: NCT00163579     History of Changes
Other Study ID Numbers: BS-2004-UFK-1
171-03 ethical commitee
2004 DR 5192 swissmedic
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: April 16, 2009
Last Verified: September 2005

Keywords provided by Basel Women’s University Hospital:
premature birth
drug therapy

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications