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Can Acupuncture be Used as Preparation for Induction of Labour

This study is currently recruiting participants.
Information provided by Skejby Hospital

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Descriptive Information Fields
Brief Title  Can Acupuncture be Used as Preparation for Induction of Labour
Official Title  Randomised Study of the Effect of Acupuncture as Induction of Labour
Brief Summary

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.

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.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Primary Outcome Measure  In active delivery or not (over or equal to 3 cm) [ Time Frame: 24 hrs. ] [ Designated as safety issue: No ]
Secondary Outcome Measure  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 ]
Condition  Pregnancy Overdue - Week 41+6
Intervention  Device: acupuncture
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  124
Start Date  November 2005
Completion Date September 2008
Eligibility 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
Gender Female
Ages
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Jette Modlock, develop midw     45-99276356     jemod@ringamt.dk    
Location Countries  Denmark
Administrative Information Fields
NCT ID  NCT00245752
Organization ID 20040001
Secondary IDs ††
Study Sponsor  Skejby Hospital
Collaborators †† Skejby Research Fond
Ringkjøbing County Research Fond
Union of Midwives Research Fond
Investigators 
Principal Investigator:     Niels Uldbjerg, Professor     unaffiliated    
Information Provided By Skejby Hospital
Verification Date June 2008
First Received Date  October 26, 2005
Last Updated Date July 1, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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