Acupuncture for the Prevention of Postdates Pregnancy

NCT ID: NCT00312585

Last Updated: 2016-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-03-31

Brief Summary

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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

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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

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Acupuncture

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

Sham Acupuncture

Group Type SHAM_COMPARATOR

Sham comparator

Intervention Type PROCEDURE

Usual care only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Acupuncture

Intervention Type PROCEDURE

Sham comparator

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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University of North Carolina at Chapel Hill

Principal Investigators

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Teresa Harper, MD

Role: PRINCIPAL_INVESTIGATOR

UNC-Chapel Hill Department of Ob/Gyn

Locations

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UNC-Chapel Hill Family Medicine Center

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 16966110 (View on PubMed)

Other Identifiers

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G0418

Identifier Type: -

Identifier Source: org_study_id

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