Efficacy of Acupuncture on Induction of Labor

This study has been completed.
Sponsor:
Information provided by:
University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier:
NCT01052857
First received: December 11, 2007
Last updated: January 19, 2010
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Labor
Pregnancy
Procedure: acupuncture
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Acupuncture on Induction of Labor

Resource links provided by NLM:


Further study details as provided by University of Modena and Reggio Emilia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • to evaluate safety of acupuncture [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: November 2007
Study Completion Date: January 2009
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
acupuncture daily fo 7 days
Procedure: acupuncture
acupuncture application
No Intervention: 2
observation

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Fetal or maternal disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052857

Locations
Italy
University of Modena and Reggio Emilia
Modena, Mo, Italy, 41100
University of Modena and reggio emilia
Modena, Italy, 41100
Sponsors and Collaborators
University of Modena and Reggio Emilia
Investigators
Principal Investigator: facchinetti Fabio, MD University of Modena and Reggio Emilia
  More Information

No publications provided

Responsible Party: Facchinetti Fabio, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT01052857     History of Changes
Other Study ID Numbers: acupuncture
Study First Received: December 11, 2007
Last Updated: January 19, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by University of Modena and Reggio Emilia:
to evaluate acupuncture as possible alternative treatment for induction of labor
Induction
treatment
posterm

ClinicalTrials.gov processed this record on August 20, 2014