Cesarean Section
Conditions
Keywords
Caesarian Section, Homeopathy, Pain, Analgesia
Brief summary
The planned study will be conducted in a prospective, randomized, double blind placebo controlled manner. Two anti-traumatic Homeopathic remedies (Arnica montana and Staphysagria) will be used. The selection of these remedies was based on a previous trial that showed a statistical difference in Hemoglobin levels favoring pregnant women treated with these drugs following delivery. The proposed study will focus on the post-operative recovery of women undergoing Cesarean section. According to Homeopathic principles, these two remedies are believed to improve the vital force, and will therefore improve convalescence following surgery in the study group. The study will include 90 women between the ages of 18 and 50 years who are scheduled for elective Cesarean Section. Exclusion criteria are: obesity (above 100kg), malignancy, psychiatric illness, diabetes and multipara pregnancies. Participants will be inducted following a detailed explanation by an MD and signing of an informed consent form, and then subdivided randomly into three groups numbering 30 in each: Two groups will be treated with homeopathic drugs of varied doses, and the third will get a placebo remedy which is indistinguishable from the other drugs. Outcome measures will include: 1. Blood loss - as estimated by a reduction in serum Hemoglobin levels. 2. Pain -to be evaluated by a numerical rating score (NRS) 3. Analgesic use 4. Length of post-operative stay and complications. 5. Quality of life outcomes - to be assessed using the MOS SF-36 questionnaire at one and four weeks following surgery. Although not expected, adverse events will be monitored. If, as we anticipate, the homeopathic treatment proves to be both safe and effective in shortening the duration of post-operative healing, this will have significant implications, with respect to both healthcare costs and patient suffering. It will also open the door for further research in the field of trauma medicine, as well as other stress-related illness.
Interventions
DRUGBellis perennis and Staphysagria (C6)
homeopathic remedy
DRUGBellis perennis and Staphysagria (C30)
Homeopathic Remedy
DRUGPlacebo
Placebo remedy, identical in size, shape and taste to treatment remedies
Sponsors
Shaare Zedek Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* women hospitalized for elective C. Section, from the 1st to 3rd pregnancies. * Age \< 50 years * Body weight \< 100 kg * Signing of informed consent form
Exclusion criteria
1. suspected/proven malignancy 2. underlying Axis-1 psychiatric illness 3. age \< 18 years 4. diabetes mellitus (NIDDM/IDDM) 5. unable to comply with study proceedings
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pain, to be evaluated using a numerical rating score (NRS) on a 100mm scale (0= no pain whatsoever, 100 = unbearable pain). | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Hospital Stay | 4 weeks |
| Time from Surgery to First Bowel Movement | 4 days |
| Blood Loss | 4 days |
| Analgesic Use | 4 weeks |
| Quality of Life Assessment | 4 weeks |
| Adverse Effects of Treatment | 4 days |
| Post-operative Complications the following complications will be noted: Nausea, vomiting, abdominal distension, fever, urinary tract infection, thrombophlebitis, wound infection, wound hematoma, ileus, vaginal bleeding. | 4 weeks |
Countries
Israel
Outcome results
None listed