Homeopathic Remedy for the Third Stage of Delivery

Third Stage of Labor Clinical Trial

Official title:

Effect of a Homeopathic Remedy on the Third Stage of Delivery: a Prospective, Randomized, Double-Blind Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156194
• Other study ID #: ArBel.2010
• Status: Completed
• Phase: Phase 3
• First received: July 1, 2010
• Last updated: February 19, 2012
• Start date: January 2011
• Est. completion date: January 2012

Study information

• Verified date: February 2012
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel, Ministry of Health:Pharmacy Division
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Third Stage of Labor

Intervention

Drug:
• Homeopathy 1
Arnica montana C6 and Bellis perennis C6
• Homeopathy 2
Arnica montana C30 and Bellis perennis C30
• Placebo
globule identical to true homeopathy comparators

Locations

Country	Name	City	State
Israel	Maternity Ward, Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin levels at 2d postpartum		48h	Yes
Secondary	incidence of endometritis		7d	Yes
Secondary	time to extrusion of placenta following birth		24h	Yes
Secondary	duration of lochiae secretion		7days	No
Secondary	duration of third stage of labor		24h	Yes
Secondary	assessment of quality-of-life parameters		7 days	No
Secondary	assess toxic effects of the homeopathic remedies		7 days	Yes
Secondary	serum cortisol levels		within 12h postpartum	No
Secondary	state of perineum postpartum		48h	Yes