The Impact of Bryophyllum on Preterm Delivery

Preterm Delivery Clinical Trial

Official title:

The Impact of the Prophylactic or Therapeutic Application of Bryophyllum on Preterm Delivery - a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00163579
• Other study ID #: BS-2004-UFK-1
• Secondary ID: 2004 DR 5192 swi
• Status: Completed
• Phase: Phase 4
• Start date: July 2004
• Est. completion date: July 2009

Study information

• Verified date: April 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Shortening
• Premature Birth
• Preterm Contractions
• Preterm Delivery

Intervention

Drug:
• Bryophyllum

Other:
• Placebo

Locations

Country	Name	City	State
Switzerland	Obstetrical Unit, Women's University Hospital Basel	Basel	Basel Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

Gwehenberger B, Rist L, Huch R, von Mandach U. Effect of Bryophyllum pinnatum versus fenoterol on uterine contractility. Eur J Obstet Gynecol Reprod Biol. 2004 Apr 15;113(2):164-71. — View Citation

Plangger N, Rist L, Zimmermann R, von Mandach U. Intravenous tocolysis with Bryophyllum pinnatum is better tolerated than beta-agonist application. Eur J Obstet Gynecol Reprod Biol. 2006 Feb 1;124(2):168-72. Epub 2005 Jul 26. — View Citation

Vilàghy I. [Decreasing the rate of premature delivery with phytotherapy--results from general practice]. Ther Umsch. 2002 Dec;59(12):696-701. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extension of pregnancy
Secondary	Rate of preterm deliveries, rate of side effects, days of hospitalisation, rate of lung maturation.