Homeopathic Remedy for the Third Stage of Delivery

Study Overview
=================
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).

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

Conditions
-----------------
Third Stage of Labor

Intervention / Treatment
-----------------
* Drug: Homeopathy 1
* Drug: Homeopathy 2
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
third stage, labor, postpartum hemorrhage, homeopathy, arnica, bellis perennis