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

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

MedlinePlus related topics:

Acupuncture Childbirth

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Official Title:	Randomised Study of the Effect of Acupuncture as Induction of Labour

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 ]

Estimated Enrollment:	124
Study Start Date:	November 2005
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 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.
2: Sham Comparator sham acupuncture	Device: acupuncture acupuncture in points bilaterally: BL 67, LI 4, SP6, one in GV20.

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

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

Responsible Party:	Skejby Hospital ( Jette Modlock )
Study ID Numbers:	20040001
First Received:	October 26, 2005
Last Updated:	July 1, 2008
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 July 03, 2008

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