The Impact of Bryophyllum on Preterm Delivery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Basel Women’s University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Basel Women’s University Hospital
ClinicalTrials.gov Identifier:
NCT00163579
First received: September 9, 2005
Last updated: April 14, 2009
Last verified: September 2005
  Purpose

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 Intervention Phase
Preterm Delivery
Preterm Contractions
Cervical Shortening
Drug: Bryophyllum
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: The Impact of the Prophylactic or Therapeutic Application of Bryophyllum on Preterm Delivery - a Prospective Study

Further study details as provided by Basel Women’s University Hospital:

Primary Outcome Measures:
  • Extension of pregnancy

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

Estimated Enrollment: 180
Study Start Date: July 2004
Estimated Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163579

Contacts
Contact: Olav Lapaire, MD 01-6176361468 olapaire@uhbs.ch
Contact: Irène Hoesli, MD 0041 61 265 90 17 ihoesli@uhbs.ch

Locations
Switzerland
Obstetrical Unit, Women's University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Irène Hoesli, MD    0041 61 265 90 17    ihoesli@uhbs.ch   
Contact: Wolfgang Holzgreve, Professor    0041 61 265 90 99    wholzgreve@uhbs.ch   
Principal Investigator: Irène Hoesli, MD         
Sponsors and Collaborators
Basel Women’s University Hospital
Investigators
Principal Investigator: Irène Hoesli, MD Women's University Hospital, Basel, Switzerland
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00163579     History of Changes
Other Study ID Numbers: BS-2004-UFK-1, 171-03 ethical commitee, 2004 DR 5192 swissmedic
Study First Received: September 9, 2005
Last Updated: April 14, 2009
Health Authority: Switzerland: Swissmedic

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

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

ClinicalTrials.gov processed this record on October 28, 2014