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NCT01052857 Clinical Trial

Efficacy of Acupuncture on Induction of Labor

Pregnancy Clinical Trial

Official title:
Efficacy of Acupuncture on Induction of Labor

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01052857
Other study ID # acupuncture
Secondary ID
Status Completed
Phase Phase 0
First received December 11, 2007
Last updated January 19, 2010
Start date November 2007
Est. completion date January 2009

Study information
Verified date December 2007
Source University of Modena and Reggio Emilia
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date January 2009
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Fetal or maternal disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• acupuncture
acupuncture application

Locations
Country Name City State
Italy University of Modena and Reggio Emilia Modena Mo
Italy University of Modena and reggio emilia Modena

Sponsors (1)
Lead Sponsor Collaborator
University of Modena and Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary to evaluate the efficacy of acupuncture administered daily from 40 weeks + 4 days of gestation for induction of labor respect with placebo 7 days Yes
Secondary to evaluate safety of acupuncture 7 days Yes
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