Third Stage of LaborPhase 3NCT01156194
Homeopathic Remedy for the Third Stage of Delivery
A Phase 3 study testing Homeopathy 1 and Homeopathy 2 in people with Third Stage of Labor, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Third Stage of Labor
- What is being tested?
- Homeopathy 1 and Homeopathy 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Jan 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy women in 3rd stage of labor
- age 20-35
- second to fifth gestation
- spontaneous PV delivery
- term delivery (37-42nd weeks)
Who cannot join
- scarred uterus
- multifetal pregnancy
- history of bleeding problems
- caesarian section delivery
- chorioamnionitis
- pregnancy-induced hypertension
Show all 9Show fewer
- gestational diabetes mellitus
- polyhydramnios, premature rupture of membrane
- suspected macrosomy/SGA
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Third Stage of Labor
- Being tested
- Homeopathy 1, Homeopathy 2, Placebo
- Keywords
- third stage, labor, postpartum hemorrhage, homeopathy, arnica, bellis perennis
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homeopathy 1Drug
Arnica montana C6 and Bellis perennis C6
Homeopathy 2Drug
Arnica montana C30 and Bellis perennis C30
PlaceboDrug
globule identical to true homeopathy comparators
| Study group | Role | What they receive |
|---|---|---|
| Homeopathy 1 | Active comparator | Arnica montana C6 and Bellis perennis C6 Receives: Drug: Homeopathy 1 |
| Homeopathy 2 | Active comparator | Arnica montana C30 and Bellis perennis C30 Receives: Drug: Homeopathy 2 |
| Placebo | Placebo comparator | globules identical to true comparators Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin levels at 2d postpartum
Measured: 48h
Secondary outcomes (8)
incidence of endometritis
Measured: 7d
time to extrusion of placenta following birth
Measured: 24h
duration of lochiae secretion
Measured: 7days
duration of third stage of labor
Measured: 24h
assessment of quality-of-life parameters
Measured: 7 days
assess toxic effects of the homeopathic remedies
Measured: 7 days
serum cortisol levels
Measured: within 12h postpartum
state of perineum postpartum
Measured: 48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Third Stage of LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menachem Oberbaum, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156194
- Sponsor's protocol ID
- ArBel.2010
- Status last verified
- Feb 2012
- First submitted
- 1 Jul 2010
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Homeopathic Remedy on the Third Stage of Delivery: a Prospective, Randomized, Double-Blind Study.
- ClinicalTrials.gov ID
- NCT01156194
- Acronym / sponsor ID
- ArBel.2010
- Conditions
- Third Stage of Labor
- Keywords
- third stage, labor, postpartum hemorrhage, homeopathy, arnica, bellis perennis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 2 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Homeopathy 1 | Active comparator | Drug: Homeopathy 1Arnica montana C6 and Bellis perennis C6 |
| Homeopathy 2 | Active comparator | Drug: Homeopathy 2Arnica montana C30 and Bellis perennis C30 |
| Placebo | Placebo comparator | Drug: Placeboglobules identical to true comparators |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy women in 3rd stage of labor
- age 20-35
- second to fifth gestation
- spontaneous PV delivery
- term delivery (37-42nd weeks)
Key exclusion criteria (9 listed)
- scarred uterus
- multifetal pregnancy
- history of bleeding problems
- caesarian section delivery
- chorioamnionitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Homeopathy 1Arnica montana C6 and Bellis perennis C6 | Drug | Homeopathy 1 |
| Homeopathy 2Arnica montana C30 and Bellis perennis C30 | Drug | Homeopathy 2 |
| Placeboglobule identical to true homeopathy comparators | Drug | Placebo |
Primary outcome
Hemoglobin levels at 2d postpartum
Time frame: 48h
8 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
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Active, not recruitingObservational study
Intact Cord Placental Delivery vs Delayed Cord Clamping
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Homeopathy 1 and Homeopathy 2 in people with Third Stage of Labor, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin levels at 2d postpartum (time frame: 48h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2012.