Homeopathic Remedy for the Third Stage of Delivery

NCT ID: NCT01156194

Last Updated: 2012-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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Third Stage of Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Homeopathy 1

Arnica montana C6 and Bellis perennis C6

Group Type ACTIVE_COMPARATOR

Homeopathy 1

Intervention Type DRUG

Arnica montana C6 and Bellis perennis C6

Homeopathy 2

Arnica montana C30 and Bellis perennis C30

Group Type ACTIVE_COMPARATOR

Homeopathy 2

Intervention Type DRUG

Arnica montana C30 and Bellis perennis C30

Placebo

globules identical to true comparators

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

globule identical to true homeopathy comparators

Interventions

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Homeopathy 1

Arnica montana C6 and Bellis perennis C6

Intervention Type DRUG

Homeopathy 2

Arnica montana C30 and Bellis perennis C30

Intervention Type DRUG

Placebo

globule identical to true homeopathy comparators

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy women in 3rd stage of labor
* age 20-35
* second to fifth gestation
* spontaneous PV delivery
* term delivery (37-42nd weeks)

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Menachem Oberbaum

Director, Center for Integrative Complementary Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Maternity Ward, Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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ArBel.2010

Identifier Type: -

Identifier Source: org_study_id

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