Can Acupuncture be Used as Preparation for Induction of Labour - Full Text View

Sponsor:	Skejby Hospital
Collaborators:	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 labor or even be used as method for induction, and thereby eliminating other and more potentially harmful methods.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomised Study of the Effect of Acupuncture as Induction of Labour

Resource links provided by NLM:

MedlinePlus related topics: Acupuncture Acute Bronchitis

U.S. FDA Resources

Further study details as provided by Skejby Hospital:

Primary Outcome Measures:

In active delivery or not (over or equal to 3 cm) [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	125
Study Start Date:	November 2005
Study Completion Date:	December 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A in points bilaterally inBL 67, LI 4, SP6, one in GV20.	Device: acupuncture acupuncture in points bilaterally: BL 67, LI 4, SP6, one in GV20. Other Names: Seirin Steel needles and Park Sham needles
Sham Comparator: 2 sham acupuncture	Device: acupuncture acupuncture in points bilaterally: BL 67, LI 4, SP6, one in GV20. Other Names: Seirin Steel needles and Park Sham needles

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.

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

Contacts and Locations

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

Sponsors and Collaborators

Skejby Hospital

Skejby Research Fond

Ringkjøbing County Research Fond

Union of Midwives Research Fond

Investigators

Principal Investigator:

Niels Uldbjerg, Professor

More Information

No publications provided by Skejby Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2010 Jun 24.

Responsible Party:	Jette Modlock, Skejby Hospital
ClinicalTrials.gov Identifier:	NCT00245752 History of Changes
Other Study ID Numbers:	20040001
Study First Received:	October 26, 2005
Last Updated:	February 4, 2009
Health Authority:	Denmark: Ethics Committee

Keywords provided by Skejby Hospital:

post term pregnancy
acupuncture
induction

ClinicalTrials.gov processed this record on February 09, 2012