Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00163579
Status:
COMPLETED
Last Update Posted:
2019-04-04
First Post:
2005-09-09
Brief Title:
The Impact of Bryophyllum on Preterm Delivery
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
The Impact of the Prophylactic or Therapeutic Application of Bryophyllum on Preterm Delivery - a Prospective Study
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg of the placenta fetus uterus or endocrine dysfunctions may lead to preterm deliveries or preterm contractions
Traditional diagnostic tools for preterm contractionspreterm 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 eg 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 egtachycardia 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 eg 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 contractionspreterm deliveries
Bryophyllum or Placebo will be given prophylactic or parallel with conventional labor inhibitors in case of preterm contractions
An exact ascertainment of the etiology of preterm delivery is hardly possible because multiple partly overlapping or multifactorial etiologies exist Various pathologies eg of the placenta fetus uterus or endocrine dysfunctions may lead to preterm deliveries or preterm contractions
Traditional diagnostic tools for preterm contractionspreterm 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 eg 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 egtachycardia 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 eg 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 contractionspreterm deliveries
Bryophyllum or Placebo will be given prophylactic or parallel with conventional labor inhibitors in case of preterm contractions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004 DR 5192 swissmedic | OTHER | Swissmedic | None |