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Homeopathic Remedy for the Third Stage of Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01156194
Recruitment Status : Completed
First Posted : July 2, 2010
Last Update Posted : February 22, 2012
Sponsor:
Information provided by (Responsible Party):
Menachem Oberbaum, Shaare Zedek Medical Center

Tracking Information
First Submitted Date  ICMJE July 1, 2010
First Posted Date  ICMJE July 2, 2010
Last Update Posted Date February 22, 2012
Study Start Date  ICMJE January 2011
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2010)
Hemoglobin levels at 2d postpartum [ Time Frame: 48h ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01156194 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2010)
  • incidence of endometritis [ Time Frame: 7d ]
  • time to extrusion of placenta following birth [ Time Frame: 24h ]
  • duration of lochiae secretion [ Time Frame: 7days ]
  • duration of third stage of labor [ Time Frame: 24h ]
  • assessment of quality-of-life parameters [ Time Frame: 7 days ]
  • assess toxic effects of the homeopathic remedies [ Time Frame: 7 days ]
  • serum cortisol levels [ Time Frame: within 12h postpartum ]
  • state of perineum postpartum [ Time Frame: 48h ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Homeopathic Remedy for the Third Stage of Delivery
Official Title  ICMJE Effect of a Homeopathic Remedy on the Third Stage of Delivery: a Prospective, Randomized, Double-Blind Study.
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Third Stage of Labor
Intervention  ICMJE
  • Drug: Homeopathy 1
    Arnica montana C6 and Bellis perennis C6
  • Drug: Homeopathy 2
    Arnica montana C30 and Bellis perennis C30
  • Drug: Placebo
    globule identical to true homeopathy comparators
Study Arms  ICMJE
  • Active Comparator: Homeopathy 1
    Arnica montana C6 and Bellis perennis C6
    Intervention: Drug: Homeopathy 1
  • Active Comparator: Homeopathy 2
    Arnica montana C30 and Bellis perennis C30
    Intervention: Drug: Homeopathy 2
  • Placebo Comparator: Placebo
    globules identical to true comparators
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: July 1, 2010)
210
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01156194
Other Study ID Numbers  ICMJE ArBel.2010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Menachem Oberbaum, Shaare Zedek Medical Center
Study Sponsor  ICMJE Shaare Zedek Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shaare Zedek Medical Center
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP