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Can Acupuncture be Used as Preparation for Induction of Labour
This study has been completed.
Study NCT00245752   Information provided by Skejby Hospital
First Received: October 26, 2005   Last Updated: February 4, 2009   History of Changes

October 26, 2005
February 4, 2009
November 2005
July 2008   (final data collection date for primary outcome measure)
In active delivery or not (over or equal to 3 cm) [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
  • In active delivery or not (over or equal to 3 cm)
  • The test person will be effect evaluated 24 hours after the first acupuncture treatment,
  • Delivered or not.
Complete list of historical versions of study NCT00245752 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Internal examination to assess the
  • Degree of dilatation of orificium
  • Ruptured membranes or not,
  • Increase in uterine activity or not,
 
Can Acupuncture be Used as Preparation for Induction of Labour
Randomised Study of the Effect of Acupuncture as Induction of Labour

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.

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.

Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Pregnancy Overdue - Week 41+6
Device: acupuncture
  • Active Comparator: in points bilaterally inBL 67, LI 4, SP6, one in GV20.
  • Sham Comparator: sham acupuncture
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
125
December 2008
July 2008   (final data collection date for primary outcome measure)

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
Female
 
Yes
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00245752
Jette Modlock, Skejby Hospital
20040001
Skejby Hospital
  • Skejby Research Fond
  • Ringkjøbing County Research Fond
  • Union of Midwives Research Fond
Principal Investigator: Niels Uldbjerg, Professor unaffiliated
Skejby Hospital
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP