Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Can Acupuncture be Used as Preparation for Induction of Labour

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00245752
Recruitment Status : Completed
First Posted : October 28, 2005
Last Update Posted : February 5, 2009
Sponsor:
Collaborators:
Skejby Research Fond
Ringkjøbing County Research Fond
Union of Midwives Research Fond
Information provided by:
Aarhus University Hospital Skejby

Tracking Information
First Submitted Date  ICMJE October 26, 2005
First Posted Date  ICMJE October 28, 2005
Last Update Posted Date February 5, 2009
Study Start Date  ICMJE November 2005
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2009)
In active delivery or not (over or equal to 3 cm) [ Time Frame: 24 hrs ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 27, 2005)
  • 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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2008)
  • Degree of dilatation of orificium [ Time Frame: 24 hrs ]
  • Ruptured membranes or not, [ Time Frame: 24 hrs ]
  • Increase in uterine activity or not, [ Time Frame: 24 hrs ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2005)
  • Internal examination to assess the
  • Degree of dilatation of orificium
  • Ruptured membranes or not,
  • Increase in uterine activity or not,
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Can Acupuncture be Used as Preparation for Induction of Labour
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pregnancy Overdue - Week 41+6
Intervention  ICMJE Device: acupuncture
acupuncture in points bilaterally: BL 67, LI 4, SP6, one in GV20.
Other Names:
  • Seirin Steel needles
  • and Park Sham needles
Study Arms  ICMJE
  • Active Comparator: A
    in points bilaterally inBL 67, LI 4, SP6, one in GV20.
    Intervention: Device: acupuncture
  • Sham Comparator: 2
    sham acupuncture
    Intervention: Device: acupuncture
Publications * Modlock J, Nielsen BB, Uldbjerg N. Acupuncture for the induction of labour: a double-blind randomised controlled study. BJOG. 2010 Sep;117(10):1255-61. doi: 10.1111/j.1471-0528.2010.02647.x. Epub 2010 Jun 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2009)
125
Original Enrollment  ICMJE
 (submitted: October 27, 2005)
124
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Denmark
 
Administrative Information
NCT Number  ICMJE NCT00245752
Other Study ID Numbers  ICMJE 20040001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jette Modlock, Skejby Hospital
Study Sponsor  ICMJE Aarhus University Hospital Skejby
Collaborators  ICMJE
  • Skejby Research Fond
  • Ringkjøbing County Research Fond
  • Union of Midwives Research Fond
Investigators  ICMJE
Principal Investigator: Niels Uldbjerg, Professor
PRS Account Aarhus University Hospital Skejby
Verification Date February 2009

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