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Acupuncture for the Prevention of Postdates Pregnancy

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ClinicalTrials.gov Identifier: NCT00312585
Recruitment Status : Completed
First Posted : April 10, 2006
Last Update Posted : April 7, 2016
Sponsor:
Information provided by:
University of North Carolina, Chapel Hill

Brief 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.

Condition or disease Intervention/treatment Phase
Pregnancy Procedure: Acupuncture Procedure: Sham comparator Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Acupuncture to Prevent Postdates Pregnancy
Study Start Date : February 2005
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Acupuncture Procedure: Acupuncture
Sham Comparator: Sham Acupuncture Procedure: Sham comparator
No Intervention: Usual care only



Primary Outcome Measures :
  1. prevention of inpatient induction of labor

Secondary Outcome Measures :
  1. rate of cesarean delivery
  2. rates of chorioamnionitis
  3. length of maternal hospital stay
  4. rates of assisted delivery
  5. neonatal outcomes


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • first, full-term pregnancy
  • 38-41 weeks gestation
  • English or Spanish speaking
  • Bishop score of 7 or less

Exclusion Criteria:

  • uncertain pregnancy dating
  • transportation difficulties
  • previous inability to tolerate acupuncture
  • age less than 18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312585


Locations
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United States, North Carolina
UNC-Chapel Hill Family Medicine Center
Chapel Hill, North Carolina, United States, 27599-7595
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Teresa Harper, MD UNC-Chapel Hill Department of Ob/Gyn

Publications of Results:
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Responsible Party: Remy Coeytaux, MD, University of North Carolina at Chapel Hill
ClinicalTrials.gov Identifier: NCT00312585     History of Changes
Other Study ID Numbers: G0418
First Posted: April 10, 2006    Key Record Dates
Last Update Posted: April 7, 2016
Last Verified: May 2011

Keywords provided by University of North Carolina, Chapel Hill:
pregnancy
acupuncture