PregnancyPhase 2NCT00312585
Acupuncture for the Prevention of Postdates Pregnancy
A Phase 2 study testing Acupuncture in people with Pregnancy, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this study is to assess if acupuncture can shorten the time to delivery for women who are experiencing their first, full-term pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Mar 2007
- Phase
- Phase 2
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- first, full-term pregnancy
- 38-41 weeks gestation
- English or Spanish speaking
- Bishop score of 7 or less
Who cannot join
- uncertain pregnancy dating
- transportation difficulties
- previous inability to tolerate acupuncture
- age less than 18
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC-Chapel Hill Family Medicine Center
Chapel Hill, North Carolina, 27599-7595
About this study
Official title: A Randomized Controlled Trial of Acupuncture to Prevent Postdates Pregnancy
The purpose of this study is to assess if acupuncture can shorten the time to delivery for women who are experiencing their first, full-term pregnancy.
Read the detailed description
There are certain medical conditions that can complicate pregnancies after 40 weeks gestation. However, it is not always safe or easy to put these women into labor. Acupuncture has been used in Asia for hundreds of years to induce contractions and begin the labor process. Acupuncture is not typically used in the United States to induce labor, however. The purpose of this study is to determine whether a series of up to five acupuncture treatments can prevent postdates pregnancy.
- Conditions
- Pregnancy
- Being tested
- Acupuncture, Sham comparator
- Keywords
- pregnancy, acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Sham comparatorProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Not described Receives: Procedure: Acupuncture |
| Sham Acupuncture | Sham comparator | Not described Receives: Procedure: Sham comparator |
| Usual care only | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention of inpatient induction of labor
Secondary outcomes (5)
rate of cesarean delivery
rates of chorioamnionitis
length of maternal hospital stay
rates of assisted delivery
neonatal outcomes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2006 (estimated)
- Study startFeb 2005
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Investigators
- Teresa Harper, MD, Principal investigator, UNC-Chapel Hill Department of Ob/Gyn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312585
- Sponsor's protocol ID
- G0418
- Status last verified
- May 2011
- First submitted
- 6 Apr 2006
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Harper TC, Coeytaux RR, Chen W, Campbell K, Kaufman JS, Moise KJ, Thorp JM. A randomized controlled trial of acupuncture for initiation of labor in nulliparous women. J Matern Fetal Neonatal Med. 2006 Aug;19(8):465-70. doi: 10.1080/14767050600730740.
PubMed 16966110
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Acupuncture to Prevent Postdates Pregnancy
- ClinicalTrials.gov ID
- NCT00312585
- Acronym / sponsor ID
- G0418
- Conditions
- Pregnancy
- Keywords
- pregnancy, acupuncture
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 10 Apr 2006 (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 assess if acupuncture can shorten the time to delivery for women who are experiencing their first, full-term pregnancy.
Detailed description
There are certain medical conditions that can complicate pregnancies after 40 weeks gestation. However, it is not always safe or easy to put these women into labor. Acupuncture has been used in Asia for hundreds of years to induce contractions and begin the labor process. Acupuncture is not typically used in the United States to induce labor, however. The purpose of this study is to determine whether a series of up to five acupuncture treatments can prevent postdates pregnancy.
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 |
|---|---|---|
| Acupuncture | Experimental | Procedure: Acupuncture |
| Sham Acupuncture | Sham comparator | Procedure: Sham comparator |
| Usual care only | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- first, full-term pregnancy
- 38-41 weeks gestation
- English or Spanish speaking
- Bishop score of 7 or less
Key exclusion criteria (4 listed)
- uncertain pregnancy dating
- transportation difficulties
- previous inability to tolerate acupuncture
- age less than 18
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 |
|---|---|---|
| Acupuncture | Procedure or surgery | Acupuncture |
| Sham comparator | Procedure or surgery | Sham Acupuncture |
Primary outcome
prevention of inpatient induction of labor
5 secondary outcomes
rate of cesarean delivery
rates of chorioamnionitis
length of maternal hospital stay
rates of assisted delivery
neonatal outcomes
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 7 Apr 2016.
- Results publication: PubMed 16966110Harper TC, Coeytaux RR, Chen W, Campbell K, Kaufman JS, Moise KJ, Thorp JM. A randomized controlled trial of acupuncture for initiation of labor in nulliparous women. J Matern Fetal Neonatal Med. 2006 Aug;19(8):465-70. doi: 10.1080/14767050600730740.
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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.
Teresa Harper, MD principal investigator
UNC-Chapel Hill Department of Ob/Gyn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acupuncture in people with Pregnancy, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 4 inclusion and 4 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 7 Apr 2016. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
prevention of inpatient induction of labor. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00312585, which also lists 1 linked publication.
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 7 Apr 2016.