Homeopathic Remedy for the Third Stage of Delivery
Effect of a Homeopathic Remedy on the Third Stage of Delivery: a Prospective, Randomized, Double-Blind Study.
1 other identifier
interventional
210
1 country
1
Brief Summary
The homeopathic remedy consisting of Arnica and Bellis perennis have been shown in a previous pilot study (n=33) to reduce blood loss during the third stage of delivery, when compared with placebo treatment. The purpose of this study is to repeat the previous methodology, this time on a larger population. 210 parturients will be randomized to one of three groups: Arnica montana C6 and Bellis perennis C6 (n=70), Arnica montana C30 and Bellis perennis C30 (n=70), or double placebo (n=70).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2011
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2010
CompletedFirst Posted
Study publicly available on registry
July 2, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFebruary 22, 2012
February 1, 2012
1 year
July 1, 2010
February 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin levels at 2d postpartum
48h
Secondary Outcomes (8)
incidence of endometritis
7d
time to extrusion of placenta following birth
24h
duration of lochiae secretion
7days
duration of third stage of labor
24h
assessment of quality-of-life parameters
7 days
- +3 more secondary outcomes
Study Arms (3)
Homeopathy 1
ACTIVE COMPARATORArnica montana C6 and Bellis perennis C6
Homeopathy 2
ACTIVE COMPARATORArnica montana C30 and Bellis perennis C30
Placebo
PLACEBO COMPARATORglobules identical to true comparators
Interventions
Eligibility Criteria
You may qualify if:
- healthy women in 3rd stage of labor
- age 20-35
- second to fifth gestation
- spontaneous PV delivery
- term delivery (37-42nd weeks)
You may not qualify if:
- scarred uterus
- multifetal pregnancy
- history of bleeding problems
- caesarian section delivery
- chorioamnionitis
- pregnancy-induced hypertension
- gestational diabetes mellitus
- polyhydramnios, premature rupture of membrane
- suspected macrosomy/SGA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maternity Ward, Shaare Zedek Medical Center
Jerusalem, 91031, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Center for Integrative Complementary Medicine
Study Record Dates
First Submitted
July 1, 2010
First Posted
July 2, 2010
Study Start
January 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
February 22, 2012
Record last verified: 2012-02