NCT00163579

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

5 years

First QC Date

September 9, 2005

Last Update Submit

April 2, 2019

Conditions

Preterm DeliveryPreterm ContractionsCervical Shortening

Keywords

premature birthcerclagetocolysisdrug therapy

Outcome Measures

Primary Outcomes (1)

  • Extension of pregnancy

Secondary Outcomes (1)

  • Rate of preterm deliveries, rate of side effects, days of hospitalisation, rate of lung maturation.

Study Arms (2)

Bryophyllum

EXPERIMENTAL
Drug: Bryophyllum

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

BryophyllumDRUG
Bryophyllum
PlaceboOTHER
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • Fetal malformations
  • Chromosomal anomalies
  • Intrauterine growth restriction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obstetrical Unit, Women's University Hospital Basel

Basel, Canton of Basel-City, 4031, 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

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Irène Hoesli, Prof. Dr. MD

    Women's University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

July 1, 2004

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

April 4, 2019

Record last verified: 2019-04

Locations

CH(1)