Acupuncture for the Prevention of Postdates Pregnancy

April 5, 2016 updated by: University of North Carolina, Chapel Hill

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

89

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7595
        • UNC-Chapel Hill Family Medicine Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham Acupuncture
Procedure: Sham comparator
Experimental: Acupuncture
Procedure: Acupuncture
No Intervention: Usual care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
prevention of inpatient induction of labor

Secondary Outcome Measures

Outcome Measure
neonatal outcomes
rate of cesarean delivery
rates of chorioamnionitis
length of maternal hospital stay
rates of assisted delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: Teresa Harper, MD, UNC-Chapel Hill Department of Ob/Gyn

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

April 6, 2006

First Submitted That Met QC Criteria

April 6, 2006

First Posted (Estimate)

April 10, 2006

Study Record Updates

Last Update Posted (Estimate)

April 7, 2016

Last Update Submitted That Met QC Criteria

April 5, 2016

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • G0418

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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