Homeopathic Remedy for the Third Stage of Delivery

Phase 3

Completed

• Conditions: Third Stage of Labor
• Interventions: Drug: Homeopathy 1; Drug: Homeopathy 2; Drug: Placebo

• Registration Number: NCT01156194
• Lead Sponsor: Shaare Zedek Medical Center

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-01
• Study First Submitted QC: 2010-07-01
• Study First Posted: 2010-07-02
• Study Start: 2011-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-19
• Last Update Posted: 2012-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 210

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Homeopathy 1	Homeopathy 1	Arnica montana C6 and Bellis perennis C6
Homeopathy 2	Homeopathy 2	Arnica montana C30 and Bellis perennis C30
Placebo	Placebo	globules identical to true comparators

Primary Outcome Measures

Name	Time	Method
Hemoglobin levels at 2d postpartum	48h

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Maternity Ward, Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel