Homeopathic Remedy for the Third Stage of Delivery

Shaare Zedek Medical Center

Status and phase: Completed; Phase 3

Conditions: Third Stage of Labor

Treatments: Drug: Homeopathy 2; Drug: Placebo; Drug: Homeopathy 1

Study type: Interventional

Funder types: Other

Identifiers

NCT01156194

ArBel.2010

Details and patient eligibility

About

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).

Enrollment: 210 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 3 patient groups, including a placebo group

Homeopathy 1

Active Comparator group

Description:

Arnica montana C6 and Bellis perennis C6

Treatment:

Drug: Homeopathy 1

Homeopathy 2

Active Comparator group

Description:

Arnica montana C30 and Bellis perennis C30

Treatment:

Drug: Homeopathy 2

Placebo

Placebo Comparator group

Description:

globules identical to true comparators

Treatment:

Drug: Placebo