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NCT Number: NCT01156194

Homeopathic Remedy for the Third Stage of Delivery

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).

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Key information

Conditions

Third Stage of Labor Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Maternity Ward, Shaare Zedek Medical Center

Jerusalem, 91031, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Homeopathy 1

Drug

Arnica montana C6 and Bellis perennis C6

Homeopathy 2

Drug

Arnica montana C30 and Bellis perennis C30

Placebo

Drug

globule identical to true homeopathy comparators

Primary outcomes

  1. Hemoglobin levels at 2d postpartum

    Time frame: 48h

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Shaare Zedek Medical Center

Other

Registry information

Official study title

Effect of a Homeopathic Remedy on the Third Stage of Delivery: a Prospective, Randomized, Double-Blind Study.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 2, 2010
Registry last updated
Feb 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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