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Completed

NCT Number: NCT00245752

Can Acupuncture be Used as Preparation for 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acupuncture

Device

acupuncture in points bilaterally: BL 67, LI 4, SP6, one in GV20.

Other names: Seirin Steel needles, and Park Sham needles

Primary outcomes

  1. In active delivery or not (over or equal to 3 cm)

    Time frame: 24 hrs

Secondary outcomes

  1. Degree of dilatation of orificium

    Time frame: 24 hrs

  2. Ruptured membranes or not,

    Time frame: 24 hrs

  3. Increase in uterine activity or not,

    Time frame: 24 hrs

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital Skejby

Other

Collaborators

  • Ringkjøbing County Research Fond
  • Skejby Research Fond
  • Union of Midwives Research Fond

Registry information

Official study title

Randomised Study of the Effect of Acupuncture as Induction of Labour

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Oct 28, 2005
Registry last updated
Feb 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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