Homeopathic Remedy for the Third Stage of Delivery

• Sponsor: Shaare Zedek Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01156194
• Collaborator: (none)
• Enrollment: 210
• Location: 1
• Arms: 3
• Duration (Months): 12
• Patients Per Site Per Month: 17.5

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Third Stage of Labor	Drug: Homeopathy 1; Drug: Homeopathy 2; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of a Homeopathic Remedy on the Third Stage of Delivery: a Prospective, Randomized, Double-Blind Study.
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Homeopathy 1 Arnica montana C6 and Bellis perennis C6	Drug: Homeopathy 1; Arnica montana C6 and Bellis perennis C6
Active Comparator: Homeopathy 2 Arnica montana C30 and Bellis perennis C30	Drug: Homeopathy 2; Arnica montana C30 and Bellis perennis C30
Placebo Comparator: Placebo globules identical to true comparators	Drug: Placebo; globule identical to true homeopathy comparators

Outcome Measures

Primary Outcome Measures

1. Hemoglobin levels at 2d postpartum [48h]

Secondary Outcome Measures

1. incidence of endometritis [7d]

2. time to extrusion of placenta following birth [24h]

3. duration of lochiae secretion [7days]

4. duration of third stage of labor [24h]

5. assessment of quality-of-life parameters [7 days]

6. assess toxic effects of the homeopathic remedies [7 days]

7. serum cortisol levels [within 12h postpartum]

8. state of perineum postpartum [48h]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maternity Ward, Shaare Zedek Medical Center	Jerusalem		Israel	91031

Sponsors and Collaborators

• Shaare Zedek Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Menachem Oberbaum, Director, Center for Integrative Complementary Medicine, Shaare Zedek Medical Center
• ClinicalTrials.gov Identifier: NCT01156194
• Other Study ID Numbers: ArBel.2010
• First Posted: Jul 2, 2010
• Last Update Posted: Feb 22, 2012
• Last Verified: Feb 1, 2012

• Keywords provided by Menachem Oberbaum, Director, Center for Integrative Complementary Medicine, Shaare Zedek Medical Center: third stage, labor, postpartum hemorrhage, homeopathy, arnica, bellis perennis

Study Results

No Results Posted as of Feb 22, 2012