Homeopathic Remedy for the Third Stage of Delivery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Menachem Oberbaum, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT01156194
First received: July 1, 2010
Last updated: February 19, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Third Stage of Labor
Drug: Homeopathy 1
Drug: Homeopathy 2
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Hemoglobin levels at 2d postpartum [ Time Frame: 48h ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • incidence of endometritis [ Time Frame: 7d ] [ Designated as safety issue: Yes ]
  • time to extrusion of placenta following birth [ Time Frame: 24h ] [ Designated as safety issue: Yes ]
  • duration of lochiae secretion [ Time Frame: 7days ] [ Designated as safety issue: No ]
  • duration of third stage of labor [ Time Frame: 24h ] [ Designated as safety issue: Yes ]
  • assessment of quality-of-life parameters [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • assess toxic effects of the homeopathic remedies [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • serum cortisol levels [ Time Frame: within 12h postpartum ] [ Designated as safety issue: No ]
  • state of perineum postpartum [ Time Frame: 48h ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 210
Study Start Date: January 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156194

Locations
Israel
Maternity Ward, Shaare Zedek Medical Center
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
  More Information

No publications provided

Responsible Party: Menachem Oberbaum, Director, Center for Integrative Complementary Medicine, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT01156194     History of Changes
Other Study ID Numbers: ArBel.2010
Study First Received: July 1, 2010
Last Updated: February 19, 2012
Health Authority: Israel, Ministry of Health:Pharmacy Division

Keywords provided by Shaare Zedek Medical Center:
third stage, labor, postpartum hemorrhage, homeopathy, arnica, bellis perennis

ClinicalTrials.gov processed this record on October 29, 2014