Effect of a Homeopathic Remedy on the Third Stage of Delivery: a Prospective, Randomized, Double-Blind Study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Hemoglobin levels at 2d postpartum
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy women in 3rd stage of labor
- •age 20-35
- •second to fifth gestation
- •spontaneous PV delivery
- •term delivery (37-42nd weeks)
排除标准
- •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
研究组 & 干预措施
Homeopathy 1
Arnica montana C6 and Bellis perennis C6
干预措施: Homeopathy 1 (Drug)
Homeopathy 2
Arnica montana C30 and Bellis perennis C30
干预措施: Homeopathy 2 (Drug)
Placebo
globules identical to true comparators
干预措施: Placebo (Drug)
结局指标
主要结局
Hemoglobin levels at 2d postpartum
时间窗: 48h
次要结局
- 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)
研究者
Menachem Oberbaum
Director, Center for Integrative Complementary Medicine
Shaare Zedek Medical Center