LaborEarly Phase 1NCT01052857
Efficacy of Acupuncture on Induction of Labor
A Early Phase 1 study testing acupuncture in people with Labor and Pregnancy, run by University of Modena and Reggio Emilia at 2 sites in Italy.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of acupuncture for the induction of labor in pregnant women at the 40 weeks + 4 days of gestation. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- What is being tested?
- acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesItaly
- Study dates
- Nov 2007to Jan 2009
- Phase
- Early Phase 1
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Physiological pregnant women at 40 weeks + 4 days of gestation
Who cannot join
- Fetal or maternal disease
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
University of Modena and reggio emilia
Modena, modena, 41100
University of Modena and Reggio Emilia
Modena, Mo, 41100
About this study
The purpose of this study is to evaluate the efficacy and safety of acupuncture for the induction of labor in pregnant women at the 40 weeks + 4 days of gestation.
Read the detailed description
Women at 40+2-40+4 gestational age were allocated to receive acupuncture twice a week or observation in order to observe the efficacy of acupuncture in labour onset.
- Being tested
- acupuncture
- Keywords
- to evaluate acupuncture as possible alternative treatment for induction of labor, Induction, treatment, posterm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
acupuncture application
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | acupuncture daily fo 7 days Receives: Procedure: acupuncture |
| 2 | No intervention | observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the efficacy of acupuncture administered daily from 40 weeks + 4 days of gestation for induction of labor respect with placebo
Measured: 7 days
Secondary outcomes (1)
to evaluate safety of acupuncture
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startNov 2007
- Primary completionMay 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Investigators
- facchinetti Fabio, MD, Principal investigator, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052857
- Sponsor's protocol ID
- acupuncture
- Status last verified
- Dec 2007
- First submitted
- 11 Dec 2007
- Last updated
- 20 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acupuncture on Induction of Labor
- ClinicalTrials.gov ID
- NCT01052857
- Acronym / sponsor ID
- acupuncture
- Keywords
- to evaluate acupuncture as possible alternative treatment for induction of labor, Induction, treatment, posterm
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 20 Jan 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 purpose of this study is to evaluate the efficacy and safety of acupuncture for the induction of labor in pregnant women at the 40 weeks + 4 days of gestation.
Detailed description
Women at 40+2-40+4 gestational age were allocated to receive acupuncture twice a week or observation in order to observe the efficacy of acupuncture in labour onset.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: acupunctureacupuncture daily fo 7 days |
| 2 | No intervention | –observation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Physiological pregnant women at 40 weeks + 4 days of gestation
Key exclusion criteria (1 listed)
- Fetal or maternal disease
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 |
|---|---|---|
| acupunctureacupuncture application | Procedure or surgery | 1 |
Primary outcome
to evaluate the efficacy of acupuncture administered daily from 40 weeks + 4 days of gestation for induction of labor respect with placebo
Time frame: 7 days
1 secondary outcome
to evaluate safety of acupuncture
Time frame: 7 days
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 20 Jan 2010.
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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.
facchinetti Fabio, MD principal investigator
University of Modena and Reggio Emilia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing acupuncture in people with Labor and Pregnancy, run by University of Modena and Reggio Emilia at 2 sites in Italy.
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 1 inclusion and 1 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 20 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
to evaluate the efficacy of acupuncture administered daily from 40 weeks + 4 days of gestation for induction of labor respect with placebo (time frame: 7 days). 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 20 Jan 2010.