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Can Acupuncture be Used as Preparation for Induction of Labour

This study has been completed.
Sponsor:
Collaborators:
Skejby Research Fond
Ringkjøbing County Research Fond
Union of Midwives Research Fond
Information provided by:
Skejby Hospital
ClinicalTrials.gov Identifier:
NCT00245752
First received: October 26, 2005
Last updated: February 4, 2009
Last verified: February 2009
History of Changes
  Purpose

The purpose of the study is to evaluate whether acupuncture can be used to ripen cervix before medicinal induction of labor or even be used as method for induction, and thereby eliminating other and more potentially harmful methods.


Condition Intervention Phase
Pregnancy Overdue - Week 41+6
 Device: acupuncture
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Study of the Effect of Acupuncture as Induction of Labour

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Skejby Hospital:

Primary Outcome Measures:
  • In active delivery or not (over or equal to 3 cm) [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Degree of dilatation of orificium [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
  • Ruptured membranes or not, [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
  • Increase in uterine activity or not, [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: November 2005
Study Completion Date: December 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
in points bilaterally inBL 67, LI 4, SP6, one in GV20.
 Device: acupuncture
acupuncture in points bilaterally: BL 67, LI 4, SP6, one in GV20.
Other Names:
  • Seirin Steel needles
  • and Park Sham needles
Sham Comparator: 2
sham acupuncture
 Device: acupuncture
acupuncture in points bilaterally: BL 67, LI 4, SP6, one in GV20.
Other Names:
  • Seirin Steel needles
  • and Park Sham needles

Detailed Description:

Acupuncture has become a natural part of the range of treatments in obstetric departments in Denmark, but there is only little evidence to the effect of acupuncture.

Many of the induction procedures currently in use in Denmark also have a little risk of side effects. to mention a few: There is a increased risk of maternal and neonatal infection, bleeding, ruptured membranes and placental disruption as result of the use of endocervical balloon catheter. In connection with manual rupture of membranes there is an increased risk of umbilical prolapse, maternal and neonatal infection, affected fetal heart rate, scratches on the scalp and placental bleeding. By using misoprostol there has been seen hyperstimulation of uterus causing affected fetal heart rate.

Many women are asking for alternatives to the existing methods used in obstetric dept.s.

In order to assess the effect, or lack of, acupuncture might have, we want to use acupuncture in the study group on acupuncture points on hands, feet, ankles and back of the head. The control group will get placebo acupuncture needles on same locations. The included women will be treated with the kind of acupuncture that counts for the group to which shes been allocated on gestational age 41+6 at 8:00 am and 2:30 pm.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Gestational age 41+6
  • Normal pregnancy, expecting a healthy baby
  • Verified due date

Exclusion Criteria:

  • Women who do not speak or understand Danish
  • Multiple pregnancy
  • In active labour
  • Previous sectio
  • Maternal diseases (i.e. Diabetes, preeclampsia, heart diseases)
  • Fetal diseases (i.e. foetus mors, IUGR, hydrocephalus)
  • Previous complicated delivery i.e. low Apgar score
  • Allergic to metal
  • Anticoagulatory treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245752

Sponsors and Collaborators
Skejby Hospital
Skejby Research Fond
Ringkjøbing County Research Fond
Union of Midwives Research Fond
Investigators
Principal Investigator: Niels Uldbjerg, Professor
  More Information

No publications provided by Skejby Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jette Modlock, Skejby Hospital
ClinicalTrials.gov Identifier: NCT00245752     History of Changes
Other Study ID Numbers: 20040001
Study First Received: October 26, 2005
Last Updated: February 4, 2009
Health Authority: Denmark: Ethics Committee

Keywords provided by Skejby Hospital:
post term pregnancy
acupuncture
induction

ClinicalTrials.gov processed this record on May 22, 2013