Preterm DeliveryPhase 4NCT00163579
The Impact of Bryophyllum on Preterm Delivery
A Phase 4 study testing Bryophyllum in people with Preterm Delivery and Preterm Contractions, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Delivery, Preterm Contractions, Cervical Shortening
- What is being tested?
- Bryophyllum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2004to Jul 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- Fetal malformations
- Chromosomal anomalies
- Intrauterine growth restriction
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Obstetrical Unit, Women's University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: The Impact of the Prophylactic or Therapeutic Application of Bryophyllum on Preterm Delivery - a Prospective Study
The purpose of this study is whether Bryophyllum is more effective and has less side effects than traditional labor inhibitors in preventing preterm delivery.
Read the 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.
- Conditions
- Preterm Delivery, Preterm Contractions, Cervical Shortening
- Being tested
- Bryophyllum, Placebo
- Keywords
- premature birth, cerclage, tocolysis, drug therapy
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BryophyllumDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Bryophyllum | Experimental | Not described Receives: Drug: Bryophyllum |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extension of pregnancy
Secondary outcomes (1)
Rate of preterm deliveries, rate of side effects, days of hospitalisation, rate of lung maturation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Preterm DeliveryStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irène Hoesli, Prof. Dr. MD, Principal investigator, Women's University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163579
- Sponsor's protocol ID
- BS-2004-UFK-1
- Other IDs
- 2004 DR 5192 swissmedic
- Status last verified
- Apr 2019
- First submitted
- 9 Sep 2005
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1016/j.ejogrb.2005.05.013. Epub 2005 Jul 26.
PubMed 16051414Gwehenberger 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. doi: 10.1016/S0301-2115(03)00370-1.
PubMed 15063954Vilaghy I. [Decreasing the rate of premature delivery with phytotherapy--results from general practice]. Ther Umsch. 2002 Dec;59(12):696-701. doi: 10.1024/0040-5930.59.12.696. German.
PubMed 12584959
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Prophylactic or Therapeutic Application of Bryophyllum on Preterm Delivery - a Prospective Study
- ClinicalTrials.gov ID
- NCT00163579
- Acronym / sponsor ID
- BS-2004-UFK-1
- Conditions
- Preterm Delivery, Preterm Contractions, Cervical Shortening
- Keywords
- premature birth, cerclage, tocolysis, drug therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jul 2004 (actual)
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bryophyllum | Experimental | Drug: Bryophyllum |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (3 listed)
- Fetal malformations
- Chromosomal anomalies
- Intrauterine growth restriction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bryophyllum | Drug | Bryophyllum |
| Placebo | Other | Placebo |
Primary outcome
Extension of pregnancy
1 secondary outcome
Rate of preterm deliveries, rate of side effects, days of hospitalisation, rate of lung maturation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Background: PubMed 16051414Plangger 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. doi: 10.1016/j.ejogrb.2005.05.013. Epub 2005 Jul 26.
- Background: PubMed 15063954Gwehenberger 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. doi: 10.1016/S0301-2115(03)00370-1.
- Background: PubMed 12584959Vilaghy I. [Decreasing the rate of premature delivery with phytotherapy--results from general practice]. Ther Umsch. 2002 Dec;59(12):696-701. doi: 10.1024/0040-5930.59.12.696. German.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irène Hoesli, Prof. Dr. MD principal investigator
Women's University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bryophyllum in people with Preterm Delivery and Preterm Contractions, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extension of pregnancy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00163579, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.