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.

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).

Study Overview

• Status: Completed
• Conditions: Third Stage of Labor
• Intervention / Treatment: Drug: Homeopathy 1; Drug: Homeopathy 2; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Phase 3

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91031
    • Maternity Ward, Shaare Zedek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Homeopathy 1; Arnica montana C6 and Bellis perennis C6	Drug: Homeopathy 1; Arnica montana C6 and Bellis perennis C6
Active Comparator: Homeopathy 2; Arnica montana C30 and Bellis perennis C30	Drug: Homeopathy 2; Arnica montana C30 and Bellis perennis C30
Placebo Comparator: Placebo; globules identical to true comparators	Drug: Placebo; globule identical to true homeopathy comparators

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hemoglobin levels at 2d postpartum	48h

Secondary Outcome Measures

Outcome Measure	Time Frame
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
assess toxic effects of the homeopathic remedies	7 days
serum cortisol levels	within 12h postpartum
state of perineum postpartum	48h

Collaborators and Investigators

• Sponsor: Shaare Zedek Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: July 1, 2010
• First Submitted That Met QC Criteria: July 1, 2010
• First Posted (Estimate): July 2, 2010

Study Record Updates

• Last Update Posted (Estimate): February 22, 2012
• Last Update Submitted That Met QC Criteria: February 19, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: third stage, labor, postpartum hemorrhage, homeopathy, arnica, bellis perennis
• Other Study ID Numbers: ArBel.2010