Efficacy of Acupuncture on Induction of Labor

January 19, 2010 updated by: University of Modena and Reggio Emilia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Early Phase 1

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

  • Italy
      • Modena, Italy, 41100
        • University of Modena and Reggio Emilia
    • Mo
      • Modena, Mo, Italy, 41100
        • University of Modena and Reggio Emilia

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 to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Physiological pregnant women at 40 weeks + 4 days of gestation

Exclusion Criteria:

  • Fetal or maternal disease

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
acupuncture daily fo 7 days
Procedure: acupuncture
acupuncture application
No Intervention: 2
observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
to evaluate safety of acupuncture
Time Frame: 7 days
7 days

Collaborators and Investigators

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

Sponsor

University of Modena and Reggio Emilia

Investigators

  • Principal Investigator: facchinetti Fabio, MD, University of Modena and Reggio Emilia

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

November 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

December 11, 2007

First Submitted That Met QC Criteria

January 19, 2010

First Posted (Estimate)

January 20, 2010

Study Record Updates

Last Update Posted (Estimate)

January 20, 2010

Last Update Submitted That Met QC Criteria

January 19, 2010

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • acupuncture

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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