NCT01052857

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 11, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 20, 2010

Completed
Last Updated

January 20, 2010

Status Verified

December 1, 2007

Enrollment Period

6 months

First QC Date

December 11, 2007

Last Update Submit

January 19, 2010

Conditions

LaborPregnancy

Keywords

to evaluate acupuncture as possible alternative treatment for induction of laborInductiontreatmentposterm

Outcome Measures

Primary Outcomes (1)

  • to evaluate the efficacy of acupuncture administered daily from 40 weeks + 4 days of gestation for induction of labor respect with placebo

    7 days

Secondary Outcomes (1)

  • to evaluate safety of acupuncture

    7 days

Study Arms (2)

1

EXPERIMENTAL

acupuncture daily fo 7 days

Procedure: acupuncture

2

NO INTERVENTION

observation

Interventions

acupuncturePROCEDURE

acupuncture application

1

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Fetal or maternal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Modena and reggio emilia

Modena, modena, 41100, Italy

Location

University of Modena and Reggio Emilia

Modena, Mo, 41100, Italy

Location

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • facchinetti Fabio, MD

    University of Modena and Reggio Emilia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 11, 2007

First Posted

January 20, 2010

Study Start

November 1, 2007

Primary Completion

May 1, 2008

Study Completion

January 1, 2009

Last Updated

January 20, 2010

Record last verified: 2007-12

Locations

IT(2)