Third Stage of Labor Clinical Trial
Official title:
Effect of a Homeopathic Remedy on the Third Stage of Delivery: a Prospective, Randomized, Double-Blind Study.
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).
Status | Completed |
Enrollment | 210 |
Est. completion date | January 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 35 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Maternity Ward, Shaare Zedek Medical Center | Jerusalem |
Lead Sponsor | Collaborator |
---|---|
Shaare Zedek Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hemoglobin levels at 2d postpartum | 48h | Yes | |
Secondary | incidence of endometritis | 7d | Yes | |
Secondary | time to extrusion of placenta following birth | 24h | Yes | |
Secondary | duration of lochiae secretion | 7days | No | |
Secondary | duration of third stage of labor | 24h | Yes | |
Secondary | assessment of quality-of-life parameters | 7 days | No | |
Secondary | assess toxic effects of the homeopathic remedies | 7 days | Yes | |
Secondary | serum cortisol levels | within 12h postpartum | No | |
Secondary | state of perineum postpartum | 48h | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00826735 -
The Effect of Guided Imagery on the Third Stage of Labor
|
N/A | |
Completed |
NCT04463485 -
Impact of Umbilical Cord Clamping Time on Infant Anemia
|
N/A |