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Homeopathic Remedy for the Third Stage of Delivery

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ClinicalTrials.gov Identifier: NCT01156194
Recruitment Status : Completed
First Posted : July 2, 2010
Last Update Posted : February 22, 2012
Sponsor:
Information provided by (Responsible Party):

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  (Clinical Trial)
Estimated 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 : January 2011
Primary Completion Date : January 2012
Study Completion Date : January 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 [ Time Frame: 48h ]

Secondary Outcome Measures :
  1. incidence of endometritis [ Time Frame: 7d ]
  2. time to extrusion of placenta following birth [ Time Frame: 24h ]
  3. duration of lochiae secretion [ Time Frame: 7days ]
  4. duration of third stage of labor [ Time Frame: 24h ]
  5. assessment of quality-of-life parameters [ Time Frame: 7 days ]
  6. assess toxic effects of the homeopathic remedies [ Time Frame: 7 days ]
  7. serum cortisol levels [ Time Frame: within 12h postpartum ]
  8. state of perineum postpartum [ Time Frame: 48h ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156194


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

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
First Posted: July 2, 2010    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012

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