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Can Acupuncture Be Used as Preparation for Induction of Labour

This study is currently recruiting participants.
Verified by Skejby Hospital, February 2006

Sponsors and Collaborators: Skejby Hospital
Skejby Research Fond
Ringkjøbing County Research Fond
Union of Midwives Research Fond
Information provided by: Skejby Hospital
ClinicalTrials.gov Identifier: NCT00245752
  Purpose

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


Condition Intervention Phase
Pregnancy Overdue - Week 41+6
Procedure: acupuncture
Phase II

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further study details as provided by Skejby Hospital:

Primary Outcome Measures:
  • The test person will be effect evaluated 24 hours after the first acupuncture treatment,
  • Delivered or not.
  • In active delivery or not (over or equal to 3 cm)

Secondary Outcome Measures:
  • Internal examination to assess the
  • Degree of dilatation of orificium
  • Ruptured membranes or not,
  • Increase in uterine activity or not,

Estimated Enrollment:   124
Study Start Date:   November 2005
Estimated Study Completion Date:   December 2006

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 disruptio as result of the use of endocervical ballon catheter. In connection with manual rupture of membranes there is an increased risk of umbillical 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 studygroup on acupuncture points on hands, feet, ancles 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

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  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245752

Contacts
Contact: Jette Modlock, develop midw     45-99276356     jemod@ringamt.dk    

Locations
Denmark
Skejby Hospital     Recruiting
      Århus, Denmark, 8000
      Contact: Jette Modlock, develop midw     45 99276356     jemod@ringamt.dk    

Sponsors and Collaborators
Skejby Hospital
Skejby Research Fond
Ringkjøbing County Research Fond
Union of Midwives Research Fond

Investigators
Principal Investigator:     Niels Uldbjerg, Professor     unaffiliated    
  More Information

Study ID Numbers:   20040001
First Received:   October 26, 2005
Last Updated:   February 1, 2006
ClinicalTrials.gov Identifier:   NCT00245752
Health Authority:   Denmark: Ethics Committee

Keywords provided by Skejby Hospital:
post term pregnancy  
acupuncture  
induction  

Study placed in the following topic categories:
Pregnancy, Prolonged

ClinicalTrials.gov processed this record on May 15, 2008