NCT00391339

Brief Summary

In a prospective, randomised study the efficacy and tolerability of bryophyllum p. (p.o) vs. nifedipine (p.o) will be proofed in a defined group of pregnant women with threatened preterm labour.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 23, 2006

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2006

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

October 23, 2006

Status Verified

October 1, 2006

First QC Date

October 19, 2006

Last Update Submit

October 19, 2006

Conditions

Tocolysis

Keywords

Bryophyllum p.NifedipineTocolysis

Interventions

Bryophyllum p.DRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female

You may not qualify if:

  • Bishop Score \> 5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics, University of Zuerich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 16051414BACKGROUND

  • 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. doi: 10.1016/S0301-2115(03)00370-1.

    PMID: 15063954BACKGROUND

  • Vilaghy 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.

    PMID: 12584959BACKGROUND

Study Officials

  • Roland Zimmermann, Prof. Dr. med.

    Department of Obstetrics, University Zuerich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 19, 2006

First Posted

October 23, 2006

Study Start

November 1, 2006

Study Completion

October 1, 2008

Last Updated

October 23, 2006

Record last verified: 2006-10

Locations

CH(1)