Clinical Trials Logo

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
First received
Last updated
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
Health authority
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

Study Design


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.
See also
  Status Clinical Trial Phase
Completed NCT03304782 - Fitbit Activity Tracker to Predict Risk of Preterm Birth
Recruiting NCT02420743 - Serum Ferritin Concentration and Fetal MCA Doppler as Predictors for Preterm Delivery
Completed NCT01119963 - Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM) Phase 2/Phase 3
Completed NCT01665378 - Impact of Pre-pregnancy Micronutrient Supplementation on Maternal and Child Outcomes N/A
Completed NCT00141908 - Prevention of Preterm Delivery in Twin Pregnancies by 17 Alpha-hydroxyprogesterone Caproate Phase 2
Recruiting NCT05278130 - Serial Screening and Treatment of Bacterial Vaginosis Trial N/A
Terminated NCT03596125 - Correction of Neonatal Glutathione by N-acetylcysteine in Pregnant Women at Risk of Premature Birth (GSH MAP) Phase 2/Phase 3
Recruiting NCT03123926 - Spontaneous Preterm Birth Marker Test N/A
Completed NCT00201643 - A Randomized Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids (ACS) on Neonatal Outcome Phase 4
Completed NCT01353807 - Impact of Fish Oil Supplementation in 3rd Trimester of Pregnancy on Maternal and Offspring Health N/A
Terminated NCT02545127 - Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely Phase 2
Completed NCT02371356 - Comparing Effectiveness of Treating Depression With & Without Comorbidity to Improve Fetal Health
Active, not recruiting NCT01009723 - Preterm Delivery Risk Prediction by Measurement of Prenatal Serum Screening Markers N/A
Completed NCT00883324 - Comparison of Fetal Fibronectin (fFN) Specimen Collection Methodologies: With Speculum Versus Without Speculum N/A
Completed NCT00615550 - PREGNANT Short Cervix Trial Phase 3
Completed NCT02694679 - Randomized Controlled Trial of Social Network Targeting in Honduras N/A
Completed NCT01031017 - Prophylactic Administration of Natural Progesterone in the Prevention of Preterm Delivery in Twin Pregnancies Phase 4
Completed NCT00331695 - Efficacy of 17 Alpha-hydroxyprogesterones Caproate for the Prevention of Preterm Delivery Phase 4
Completed NCT00329914 - Does Progesterone Prevent Very Preterm Delivery in Twin Pregnancies? Phase 2
Completed NCT01818518 - Neonatal Outcome by Reason for Delivery